Trial Outcomes & Findings for Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy (NCT NCT05751785)
NCT ID: NCT05751785
Last Updated: 2025-07-22
Results Overview
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
COMPLETED
NA
48 participants
6-month
2025-07-22
Participant Flow
A total of 48 participants consented to be in the study. However, 2 participants were withdrawn prior to randomization due to failing formal screening criteria. This left 46 participants to be randomized into a study arm assignment.
Formal Screening (prior to study arm randomization): Post-consent, secondary exclusion of pregnancy will be determined by an hCG urine pregnancy test for females of child-bearing age and capacity. Additionally, all participants will be screened for insertional AT as the primary clinical diagnosis with a 3 part test. If the insertional AT component is identified as the primary source of Achilles pain, we formally withdrew the participants from the study prior to randomization.
Participant milestones
| Measure |
Physical Therapy (PT) Only
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Photobiomodulation Therapy (PBMT)
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
PT + Shockwave Therapy (SWT)
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + SWT and PBMT
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
|---|---|---|---|---|
|
Baseline to 3-Month Follow-Up
STARTED
|
11
|
11
|
12
|
12
|
|
Baseline to 3-Month Follow-Up
COMPLETED
|
9
|
10
|
11
|
10
|
|
Baseline to 3-Month Follow-Up
NOT COMPLETED
|
2
|
1
|
1
|
2
|
|
3-Month Follow-Up to End of Study
STARTED
|
9
|
10
|
11
|
10
|
|
3-Month Follow-Up to End of Study
Cross-over Treatment: PT Only
|
2
|
0
|
0
|
1
|
|
3-Month Follow-Up to End of Study
Cross-over Treatment: PT+PBMT
|
1
|
0
|
2
|
0
|
|
3-Month Follow-Up to End of Study
Cross-over Treatment: PT+SWT
|
1
|
3
|
1
|
1
|
|
3-Month Follow-Up to End of Study
Cross-over Treatment: PT+SWT+PBMT
|
5
|
6
|
6
|
7
|
|
3-Month Follow-Up to End of Study
Cross-over Treatment: Declined Additional Treatment
|
0
|
1
|
1
|
1
|
|
3-Month Follow-Up to End of Study
COMPLETED
|
8
|
9
|
9
|
10
|
|
3-Month Follow-Up to End of Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Baseline characteristics by cohort
| Measure |
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White (not Hispanic
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian or Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American (not Hispanic)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
46 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselineThe VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Victorian Institute of Sports Assessment - Achilles (VISA-A)
|
46.92 score on a scale
Standard Deviation 13.17
|
37.55 score on a scale
Standard Deviation 15.56
|
36.08 score on a scale
Standard Deviation 20.55
|
43.82 score on a scale
Standard Deviation 18.88
|
PRIMARY outcome
Timeframe: 3-weekThe VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Victorian Institute of Sports Assessment - Achilles (VISA-A)
|
58.30 score on a scale
Standard Deviation 18.25
|
56.33 score on a scale
Standard Deviation 19.86
|
50.17 score on a scale
Standard Deviation 16.92
|
63.90 score on a scale
Standard Deviation 12.91
|
PRIMARY outcome
Timeframe: 6-weekThe VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Victorian Institute of Sports Assessment - Achilles (VISA-A)
|
63.20 score on a scale
Standard Deviation 19.59
|
61.11 score on a scale
Standard Deviation 23.80
|
54.09 score on a scale
Standard Deviation 17.35
|
64 score on a scale
Standard Deviation 14.75
|
PRIMARY outcome
Timeframe: 12-weekThe VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Victorian Institute of Sports Assessment - Achilles (VISA-A)
|
68.40 score on a scale
Standard Deviation 15.90
|
69.33 score on a scale
Standard Deviation 17.67
|
58.10 score on a scale
Standard Deviation 16.21
|
61.10 score on a scale
Standard Deviation 20.63
|
PRIMARY outcome
Timeframe: 6-monthThe VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Victorian Institute of Sports Assessment - Achilles (VISA-A)
|
69 score on a scale
Standard Deviation 18.99
|
67.50 score on a scale
Standard Deviation 19.51
|
61.22 score on a scale
Standard Deviation 18.21
|
76.11 score on a scale
Standard Deviation 20.37
|
PRIMARY outcome
Timeframe: BaselineThe Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
59.55 score on a scale
Standard Deviation 12.90
|
47.91 score on a scale
Standard Deviation 14.47
|
46.75 score on a scale
Standard Deviation 16.87
|
50.10 score on a scale
Standard Deviation 19.64
|
PRIMARY outcome
Timeframe: 3-weekThe Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
57.70 score on a scale
Standard Deviation 17.60
|
51.33 score on a scale
Standard Deviation 18.76
|
47.75 score on a scale
Standard Deviation 17.58
|
60.90 score on a scale
Standard Deviation 19
|
PRIMARY outcome
Timeframe: 6-weekThe Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
64.30 score on a scale
Standard Deviation 9.68
|
60.78 score on a scale
Standard Deviation 12.60
|
55.27 score on a scale
Standard Deviation 14.43
|
62.11 score on a scale
Standard Deviation 15.71
|
PRIMARY outcome
Timeframe: 12-weekThe Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
60.40 score on a scale
Standard Deviation 18.58
|
65.11 score on a scale
Standard Deviation 14.47
|
54.10 score on a scale
Standard Deviation 18.18
|
65.30 score on a scale
Standard Deviation 15.30
|
PRIMARY outcome
Timeframe: 6-monthThe Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Lower Extremity Functional Scale (LEFS)
|
67.10 score on a scale
Standard Deviation 10.94
|
62.38 score on a scale
Standard Deviation 17.09
|
62.33 score on a scale
Standard Deviation 15.53
|
64.89 score on a scale
Standard Deviation 19.14
|
PRIMARY outcome
Timeframe: BaselineThe Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
3.27 score on a scale
Standard Deviation 1.96
|
4.27 score on a scale
Standard Deviation 1.66
|
5.58 score on a scale
Standard Deviation 2.29
|
3.50 score on a scale
Standard Deviation 2.87
|
PRIMARY outcome
Timeframe: 3-weekThe Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
2.60 score on a scale
Standard Deviation 1.80
|
2.67 score on a scale
Standard Deviation 1.33
|
4.17 score on a scale
Standard Deviation 2.15
|
2.50 score on a scale
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: 6-weekThe Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
1.80 score on a scale
Standard Deviation 1.72
|
2.33 score on a scale
Standard Deviation 1.83
|
3.64 score on a scale
Standard Deviation 2.84
|
2.22 score on a scale
Standard Deviation 1.93
|
PRIMARY outcome
Timeframe: 12-weekThe Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
2.00 score on a scale
Standard Deviation 1.84
|
1.89 score on a scale
Standard Deviation 1.91
|
2.80 score on a scale
Standard Deviation 2.04
|
2.30 score on a scale
Standard Deviation 2.65
|
PRIMARY outcome
Timeframe: 6-monthThe Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Defense and Veteran's Pain Rating Scale (DVPRS)
|
2.60 score on a scale
Standard Deviation 2.65
|
1.88 score on a scale
Standard Deviation 1.90
|
2.11 score on a scale
Standard Deviation 2.47
|
1.67 score on a scale
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: BaselineThe University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index (UWRI)
|
12.18 score on a scale
Standard Deviation 7.57
|
9.91 score on a scale
Standard Deviation 6.24
|
12 score on a scale
Standard Deviation 7
|
12 score on a scale
Standard Deviation 5.88
|
PRIMARY outcome
Timeframe: 3-weekThe University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index (UWRI)
|
14.10 score on a scale
Standard Deviation 8.17
|
15.56 score on a scale
Standard Deviation 4.69
|
13.42 score on a scale
Standard Deviation 9.38
|
14.90 score on a scale
Standard Deviation 7.12
|
PRIMARY outcome
Timeframe: 6-weekThe University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index (UWRI)
|
16.40 score on a scale
Standard Deviation 8.09
|
16.11 score on a scale
Standard Deviation 6.64
|
13.36 score on a scale
Standard Deviation 8.05
|
16.44 score on a scale
Standard Deviation 8
|
PRIMARY outcome
Timeframe: 12-weekThe University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index (UWRI)
|
20.80 score on a scale
Standard Deviation 7.07
|
17.89 score on a scale
Standard Deviation 4.95
|
15.50 score on a scale
Standard Deviation 6.99
|
17.30 score on a scale
Standard Deviation 7.40
|
PRIMARY outcome
Timeframe: 6-monthThe University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
University of Wisconsin Running Injury and Recovery Index (UWRI)
|
20.20 score on a scale
Standard Deviation 7.43
|
16.25 score on a scale
Standard Deviation 6.67
|
19.11 score on a scale
Standard Deviation 10.43
|
20.78 score on a scale
Standard Deviation 10.67
|
PRIMARY outcome
Timeframe: BaselinePatient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
43.92 score on a scale
Standard Deviation 5.99
|
46.96 score on a scale
Standard Deviation 9.02
|
53.81 score on a scale
Standard Deviation 10.55
|
49.20 score on a scale
Standard Deviation 8.29
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
43.88 score on a scale
Standard Deviation 4.82
|
44.55 score on a scale
Standard Deviation 6.09
|
49.63 score on a scale
Standard Deviation 11.19
|
41 score on a scale
Standard Deviation 0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
43.95 score on a scale
Standard Deviation 6.78
|
53.49 score on a scale
Standard Deviation 12.56
|
49.33 score on a scale
Standard Deviation 12.54
|
42.73 score on a scale
Standard Deviation 6.92
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain
|
56.69 score on a scale
Standard Deviation 4.77
|
57.86 score on a scale
Standard Deviation 6.32
|
59.46 score on a scale
Standard Deviation 7.31
|
53.65 score on a scale
Standard Deviation 7.74
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
48.16 score on a scale
Standard Deviation 8.55
|
52.35 score on a scale
Standard Deviation 4.67
|
54.44 score on a scale
Standard Deviation 2.30
|
50.59 score on a scale
Standard Deviation 8.91
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical Function
|
44.32 score on a scale
Standard Deviation 6.85
|
40.13 score on a scale
Standard Deviation 4.36
|
40.36 score on a scale
Standard Deviation 6.19
|
46.52 score on a scale
Standard Deviation 8.83
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Social Function
|
54.99 score on a scale
Standard Deviation 7.67
|
52.75 score on a scale
Standard Deviation 8.96
|
50.20 score on a scale
Standard Deviation 9.06
|
53.27 score on a scale
Standard Deviation 7.64
|
PRIMARY outcome
Timeframe: 3-weekPatient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
43.38 score on a scale
Standard Deviation 6.22
|
47.54 score on a scale
Standard Deviation 8.76
|
52.88 score on a scale
Standard Deviation 16.25
|
47.99 score on a scale
Standard Deviation 8.38
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
43.59 score on a scale
Standard Deviation 5.63
|
45.39 score on a scale
Standard Deviation 6.50
|
51.37 score on a scale
Standard Deviation 13.63
|
43.12 score on a scale
Standard Deviation 6.36
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
43.89 score on a scale
Standard Deviation 8.29
|
48.90 score on a scale
Standard Deviation 7.05
|
49.92 score on a scale
Standard Deviation 16.15
|
43.08 score on a scale
Standard Deviation 10.13
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain
|
53 score on a scale
Standard Deviation 6.47
|
56.80 score on a scale
Standard Deviation 3.68
|
55.35 score on a scale
Standard Deviation 7.37
|
50.93 score on a scale
Standard Deviation 9.12
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
47.92 score on a scale
Standard Deviation 7.77
|
50.58 score on a scale
Standard Deviation 6.45
|
52.48 score on a scale
Standard Deviation 9.23
|
50.19 score on a scale
Standard Deviation 8.25
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical Function
|
48.36 score on a scale
Standard Deviation 7.94
|
43.02 score on a scale
Standard Deviation 5.78
|
43.05 score on a scale
Standard Deviation 7.02
|
49.35 score on a scale
Standard Deviation 8.29
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Social Function
|
56.12 score on a scale
Standard Deviation 8.16
|
50.85 score on a scale
Standard Deviation 6.03
|
50.93 score on a scale
Standard Deviation 7.93
|
54.56 score on a scale
Standard Deviation 7.17
|
PRIMARY outcome
Timeframe: 6-weekPatient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
44.52 score on a scale
Standard Deviation 7.11
|
43.30 score on a scale
Standard Deviation 8.49
|
53.60 score on a scale
Standard Deviation 12.99
|
43.44 score on a scale
Standard Deviation 6.08
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
43.92 score on a scale
Standard Deviation 6.54
|
44.24 score on a scale
Standard Deviation 6.82
|
52.16 score on a scale
Standard Deviation 13.81
|
44.07 score on a scale
Standard Deviation 5.75
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
47.89 score on a scale
Standard Deviation 9.72
|
49.86 score on a scale
Standard Deviation 6.73
|
49.05 score on a scale
Standard Deviation 13.77
|
42.13 score on a scale
Standard Deviation 8.75
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain
|
51.21 score on a scale
Standard Deviation 7.18
|
51.57 score on a scale
Standard Deviation 6.30
|
55.26 score on a scale
Standard Deviation 7.51
|
50.84 score on a scale
Standard Deviation 7.60
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
50.45 score on a scale
Standard Deviation 3.60
|
49.27 score on a scale
Standard Deviation 6.89
|
49.96 score on a scale
Standard Deviation 9.85
|
53.06 score on a scale
Standard Deviation 8.19
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical Function
|
46.73 score on a scale
Standard Deviation 6.17
|
46.18 score on a scale
Standard Deviation 6.97
|
46.33 score on a scale
Standard Deviation 5.80
|
48.34 score on a scale
Standard Deviation 8.73
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Social Function
|
54.02 score on a scale
Standard Deviation 7.26
|
54.44 score on a scale
Standard Deviation 8.12
|
55.08 score on a scale
Standard Deviation 10.09
|
53.00 score on a scale
Standard Deviation 7.33
|
PRIMARY outcome
Timeframe: 12-weekPatient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
43.18 score on a scale
Standard Deviation 6.49
|
43.30 score on a scale
Standard Deviation 8.49
|
52.07 score on a scale
Standard Deviation 10.44
|
46.59 score on a scale
Standard Deviation 7.26
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
44.27 score on a scale
Standard Deviation 7.53
|
43.94 score on a scale
Standard Deviation 8.33
|
50.04 score on a scale
Standard Deviation 9.76
|
45.54 score on a scale
Standard Deviation 5.95
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
46.74 score on a scale
Standard Deviation 8.28
|
47.43 score on a scale
Standard Deviation 7.48
|
50.91 score on a scale
Standard Deviation 11.42
|
46.16 score on a scale
Standard Deviation 9.14
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain
|
50.46 score on a scale
Standard Deviation 8.04
|
48.56 score on a scale
Standard Deviation 8.55
|
53.72 score on a scale
Standard Deviation 8.91
|
51.44 score on a scale
Standard Deviation 8.99
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
51.71 score on a scale
Standard Deviation 7.33
|
53.71 score on a scale
Standard Deviation 4.37
|
54.57 score on a scale
Standard Deviation 3.82
|
50.51 score on a scale
Standard Deviation 9.36
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical Function
|
48.70 score on a scale
Standard Deviation 5.81
|
49.71 score on a scale
Standard Deviation 7.41
|
45.27 score on a scale
Standard Deviation 5.30
|
49.70 score on a scale
Standard Deviation 9.32
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Social Function
|
60.40 score on a scale
Standard Deviation 4.98
|
54.26 score on a scale
Standard Deviation 5.75
|
52.36 score on a scale
Standard Deviation 7.85
|
55.00 score on a scale
Standard Deviation 8.17
|
PRIMARY outcome
Timeframe: 6-monthPatient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
43.95 score on a scale
Standard Deviation 7.62
|
42.94 score on a scale
Standard Deviation 6.98
|
55.58 score on a scale
Standard Deviation 14.81
|
45.47 score on a scale
Standard Deviation 7.31
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
44.63 score on a scale
Standard Deviation 7.85
|
43.24 score on a scale
Standard Deviation 5.92
|
49.96 score on a scale
Standard Deviation 9.45
|
44.07 score on a scale
Standard Deviation 5.75
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
40.42 score on a scale
Standard Deviation 5.90
|
44.89 score on a scale
Standard Deviation 7.97
|
46.17 score on a scale
Standard Deviation 14.26
|
44.87 score on a scale
Standard Deviation 10.47
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain
|
48.11 score on a scale
Standard Deviation 7.24
|
52.46 score on a scale
Standard Deviation 5.85
|
52.63 score on a scale
Standard Deviation 7.36
|
50.30 score on a scale
Standard Deviation 10.43
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
50.49 score on a scale
Standard Deviation 3.60
|
50.48 score on a scale
Standard Deviation 7.53
|
52.40 score on a scale
Standard Deviation 11.16
|
50.90 score on a scale
Standard Deviation 10.77
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical Function
|
50.98 score on a scale
Standard Deviation 6.56
|
49.79 score on a scale
Standard Deviation 8.10
|
46.46 score on a scale
Standard Deviation 8.10
|
48.64 score on a scale
Standard Deviation 9.43
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Social Function
|
59.82 score on a scale
Standard Deviation 6.58
|
53.86 score on a scale
Standard Deviation 6.15
|
52.27 score on a scale
Standard Deviation 7.65
|
55.78 score on a scale
Standard Deviation 9.69
|
PRIMARY outcome
Timeframe: BaselineMeasures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Cross-sectional Area
|
0.85 cm
Standard Deviation 0.27
|
0.64 cm
Standard Deviation 0.11
|
0.69 cm
Standard Deviation 0.29
|
0.65 cm
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 12-weekMeasures of interest include cross-sectional area. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Cross-sectional Area
|
1.50 cm
Standard Deviation 1.39
|
0.67 cm
Standard Deviation 0.42
|
0.62 cm
Standard Deviation 0.22
|
0.71 cm
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 6-monthMeasures of interest include cross-sectional area. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Cross Sectional Area
|
0.80 cm
Standard Deviation 0.31
|
0.76 cm
Standard Deviation 0.38
|
0.70 cm
Standard Deviation 0.33
|
0.74 cm
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: BaselineMeasures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Width
|
.69 cm
Standard Deviation .16
|
.563 cm
Standard Deviation .10
|
.59 cm
Standard Deviation .31
|
.59 cm
Standard Deviation .13
|
PRIMARY outcome
Timeframe: 12-weekMeasures of interest include width of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Width
|
.66 cm
Standard Deviation .14
|
.66 cm
Standard Deviation .21
|
.65 cm
Standard Deviation .25
|
.56 cm
Standard Deviation .21
|
PRIMARY outcome
Timeframe: 6-monthMeasures of interest include width of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Width
|
.68 cm
Standard Deviation .14
|
.63 cm
Standard Deviation .19
|
.59 cm
Standard Deviation .14
|
.65 cm
Standard Deviation .12
|
PRIMARY outcome
Timeframe: BaselineMeasures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Degree of Thickening
|
1.49 cm
Standard Deviation .24
|
1.4 cm
Standard Deviation .18
|
1.45 cm
Standard Deviation .16
|
1.52 cm
Standard Deviation .10
|
PRIMARY outcome
Timeframe: 12-weekMeasures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Degree of Thickening
|
1.49 cm
Standard Deviation .20
|
1.43 cm
Standard Deviation .22
|
1.46 cm
Standard Deviation .23
|
1.37 cm
Standard Deviation .44
|
PRIMARY outcome
Timeframe: 6-monthMeasures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Degree of Thickening
|
1.55 cm
Standard Deviation .25
|
1.45 cm
Standard Deviation .24
|
1.37 cm
Standard Deviation .13
|
1.53 cm
Standard Deviation .17
|
PRIMARY outcome
Timeframe: BaselineMeasures of interest include relative neovascularity. A study team member will assess ultrasound measures at baseline for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Relative Neovascularity
|
1.00 score on a scale
Standard Deviation 1.15
|
.25 score on a scale
Standard Deviation .66
|
.43 score on a scale
Standard Deviation .73
|
.67 score on a scale
Standard Deviation .94
|
PRIMARY outcome
Timeframe: 12-weekMeasures of interest include relative neovascularity. A study team member will assess ultrasound measures at 12 weeks for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Relative Neovascularity
|
1.10 score on a scale
Standard Deviation 1.30
|
.56 score on a scale
Standard Deviation 1.07
|
.60 score on a scale
Standard Deviation .80
|
.89 score on a scale
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: 6-monthsMeasures of interest include relative neovascularity. A study team member will assess ultrasound measures at 6 months for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Relative Neovascularity
|
.60 score on a scale
Standard Deviation .92
|
.88 score on a scale
Standard Deviation 1.27
|
.89 score on a scale
Standard Deviation .99
|
.56 score on a scale
Standard Deviation .83
|
PRIMARY outcome
Timeframe: BaselineMeasures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Elastography
|
6.57 m/s
Standard Deviation .54
|
6.64 m/s
Standard Deviation .72
|
6.17 m/s
Standard Deviation .94
|
7.37 m/s
Standard Deviation .75
|
PRIMARY outcome
Timeframe: 12-weekMeasures of interest include elastography. A study team member will assess ultrasound measures at 12 weeks for both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Elastography
|
6.02 m/s
Standard Deviation .56
|
6.70 m/s
Standard Deviation .66
|
6.40 m/s
Standard Deviation 1.04
|
6.63 m/s
Standard Deviation .70
|
PRIMARY outcome
Timeframe: 6 MonthsMeasures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Elastography
|
6.89 m/s
Standard Deviation .72
|
6.63 m/s
Standard Deviation .79
|
6.34 m/s
Standard Deviation .80
|
6.76 m/s
Standard Deviation .95
|
PRIMARY outcome
Timeframe: BaselineQuantitative function in heel raises to fatigue on both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
|
15.73 heel raises
Standard Deviation 7.86
|
16.5 heel raises
Standard Deviation 8.62
|
12.67 heel raises
Standard Deviation 7.63
|
15.50 heel raises
Standard Deviation 9.09
|
PRIMARY outcome
Timeframe: 12-weekQuantitative function in heel raises to fatigue on both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
|
21.90 heel raises
Standard Deviation 6.09
|
28 heel raises
Standard Deviation 10.12
|
21.80 heel raises
Standard Deviation 8.45
|
20.60 heel raises
Standard Deviation 7.63
|
PRIMARY outcome
Timeframe: 6 MonthsQuantitative function in heel raises to fatigue on both limbs.
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
|
21.90 heel raises
Standard Deviation 10.52
|
22.13 heel raises
Standard Deviation 5.56
|
20.22 heel raises
Standard Deviation 4.13
|
21.44 heel raises
Standard Deviation 6.96
|
PRIMARY outcome
Timeframe: BaselineQuantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=12 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=11 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=12 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=11 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Hops
|
2.70 score on a scale
Standard Deviation 1.85
|
3.18 score on a scale
Standard Deviation 2.21
|
4.92 score on a scale
Standard Deviation 3.15
|
3.20 score on a scale
Standard Deviation 2.71
|
PRIMARY outcome
Timeframe: 12-weekQuantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=9 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=11 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Hops
|
1.90 score on a scale
Standard Deviation 1.45
|
.44 score on a scale
Standard Deviation .68
|
3.20 score on a scale
Standard Deviation 2.44
|
2.40 score on a scale
Standard Deviation 1.85
|
PRIMARY outcome
Timeframe: 6 MonthsQuantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Outcome measures
| Measure |
PT + SWT and PBMT
n=10 Participants
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=8 Participants
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=9 Participants
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=9 Participants
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Hops
|
2.10 score on a scale
Standard Deviation 2.88
|
.88 score on a scale
Standard Deviation 1.69
|
3.00 score on a scale
Standard Deviation 2.11
|
2.38 score on a scale
Standard Deviation 2.91
|
PRIMARY outcome
Timeframe: BaselineQuantitative function in range of motion (ROM).
Outcome measures
| Measure |
PT + SWT and PBMT
n=24 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=22 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=24 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=22 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Ankle Range of Motion (ROM)
|
12.18 degrees
Standard Deviation 4.04
|
12.18 degrees
Standard Deviation 4.39
|
12.67 degrees
Standard Deviation 9.74
|
12.40 degrees
Standard Deviation 4.18
|
PRIMARY outcome
Timeframe: 12-weekQuantitative function in range of motion (ROM)
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=18 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=22 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=20 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Ankle Range of Motion (ROM)
|
10.80 degrees
Standard Deviation 3.37
|
14.89 degrees
Standard Deviation 3.14
|
10.60 degrees
Standard Deviation 3.58
|
13.80 degrees
Standard Deviation 6.29
|
PRIMARY outcome
Timeframe: 6 MonthsQuantitative function in range of motion (ROM)
Outcome measures
| Measure |
PT + SWT and PBMT
n=20 Limbs
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).
|
Physical Therapy (PT) Only
n=16 Limbs
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Shockwave Therapy (SWT)
n=18 Limbs
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + Photobiomodulation Therapy (PBMT)
n=18 Limbs
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
|---|---|---|---|---|
|
Ankle Range of Motion (ROM)
|
11.60 degrees
Standard Deviation 5.12
|
15.75 degrees
Standard Deviation 7.64
|
10.67 degrees
Standard Deviation 4.32
|
10.22 degrees
Standard Deviation 3.46
|
Adverse Events
Physical Therapy (PT) Only
PT + Photobiomodulation Therapy (PBMT)
PT + Shockwave Therapy (SWT)
PT + SWT and PBMT
Serious adverse events
| Measure |
Physical Therapy (PT) Only
n=11 participants at risk
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person).
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 participants at risk
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
PT + Shockwave Therapy (SWT)
n=12 participants at risk
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + SWT and PBMT
n=12 participants at risk
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
|
|---|---|---|---|---|
|
Surgical and medical procedures
Shoulder Surgery
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Surgical and medical procedures
Neck Surgery
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Achilles Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Skin and subcutaneous tissue disorders
Allergy
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Sprained Ankle
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Surgical and medical procedures
Emergency Department
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
Other adverse events
| Measure |
Physical Therapy (PT) Only
n=11 participants at risk
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person).
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
|
PT + Photobiomodulation Therapy (PBMT)
n=10 participants at risk
The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.
Physical Therapy: All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Photobiomodulation Therapy: PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
|
PT + Shockwave Therapy (SWT)
n=12 participants at risk
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.
Shockwave Therapy: A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
|
PT + SWT and PBMT
n=12 participants at risk
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Achilles Pain in non-study leg
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Cervical Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Heel Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Achilles
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Knee Injury
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Aggravated Achilles
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Food poison
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 2 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Foot and Achilles Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased Knee Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Sore Calf
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Running increases Pain
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Surgical and medical procedures
Cortisone Injection
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased soreness from standing
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased soreness in Achilles
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascia in non-study leg
|
9.1%
1/11 • Number of events 2 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Left Knee Injury
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Injury
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Treatment for Pain
|
9.1%
1/11 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased left Achilles Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
10.0%
1/10 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increased Achilles Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 2 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Achilles Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Ankle Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Eye disorders
Injection in the eye
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Soreness, tenderness, and stiffness in a Achilles
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Soreness in Calf
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Slight increase in Achilles symptoms
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Injury, poisoning and procedural complications
Hamstring Injury
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Tightness in Achilles
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Increase in Achilles Symptoms
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Non-Study Foot
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Emergency Department
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Worsening of Pain
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Surgical and medical procedures
Teeth Extraction
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Non-study Achilles
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Lingering Pain in Achilles
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Pain and Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Calf Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Achilles Soreness
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Neck and Back
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Tingling Sensation
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
|
Musculoskeletal and connective tissue disorders
Heel Issue
|
0.00%
0/11 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/10 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
0.00%
0/12 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
8.3%
1/12 • Number of events 1 • All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.
The study overall is considered to be minimal risk for study participants: not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of Achilles tendinopathy. All reportable events, regardless of severity, were reported to the Principal Investigator and the Institutional Review Board. All adverse events were reviewed and made a determination of severity and relationship to participation in the research study.
|
Additional Information
Ms. Elizabeth Metzger, Senior Scientific Program Manager
The Geneva Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place