Trial Outcomes & Findings for Low-Level Laser Therapy for Plantar Fasciitis (NCT NCT05763381)
NCT ID: NCT05763381
Last Updated: 2025-06-04
Results Overview
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
3-Week
Results posted on
2025-06-04
Participant Flow
71 consented to participate in the study.
71 participants consented, 2 were withdrawn prior to randomization (1 self-withdrawal, 1 withdrawn by PI). 69 were randomized to the study treatments.
Participant milestones
| Measure |
The Usual Care + PBM Group
Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size).
PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons.
At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
|
Overall Study
Cross-over to Intervention
|
0
|
26
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
The Usual Care + PBM Group
Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size).
PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons.
At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Low-Level Laser Therapy for Plantar Fasciitis
Baseline characteristics by cohort
| Measure |
The Usual Care + PBM Group
n=34 Participants
Participants that were assigned to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received receive 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=35 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time was calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
Total
n=69 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
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White(Not Hispanic)
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=34 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=35 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
11.65 Percentage of function
Standard Deviation 5.84
|
11.72 Percentage of function
Standard Deviation 6.29
|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
47.00 Percentage of function
Standard Deviation 13.97
|
45.28 Percentage of function
Standard Deviation 12.42
|
PRIMARY outcome
Timeframe: 3-WeekPopulation: 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up.
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=33 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
54.00 Percentage of function
Standard Deviation 11.82
|
53.79 Percentage of function
Standard Deviation 12.68
|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
15.42 Percentage of function
Standard Deviation 5.91
|
13.27 Percentage of function
Standard Deviation 6.72
|
PRIMARY outcome
Timeframe: 6-weekPopulation: 62 enrolled participants completed 6-week follow-up and were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up.
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=31 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
56.81 Percentage of function
Standard Deviation 14.79
|
53.26 Percentage of function
Standard Deviation 14.64
|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
17.84 Percentage of function
Standard Deviation 6.60
|
13.58 Percentage of function
Standard Deviation 7.06
|
PRIMARY outcome
Timeframe: 3-monthPopulation: 31 participants from the Usual Care + PBM Group and 4 participants from the Usual Care + Sham (Placebo) PBM Group completed 3-month randomized followed up. 26 randomized participants from the Usual Care + Sham (Placebo) PBM Group crossed over at 6-week follow-up and received the study intervention.
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=4 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
17.35 Percentage of function
Standard Deviation 8.49
|
10.75 Percentage of function
Standard Deviation 8.17
|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
58.29 Percentage of function
Standard Deviation 18.06
|
52.00 Percentage of function
Standard Deviation 18.69
|
PRIMARY outcome
Timeframe: BaselineDefense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=34 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=35 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
4.97 pain units on a scale
Standard Deviation 2.09
|
5.17 pain units on a scale
Standard Deviation 1.85
|
PRIMARY outcome
Timeframe: 3-WeekPopulation: 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up.
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=33 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
4.19 pain units on a scale
Standard Deviation 2.09
|
4.03 pain units on a scale
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: 6-WeekPopulation: 62 enrolled participants were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up.
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=31 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
3.71 pain units on a scale
Standard Deviation 1.99
|
4.00 pain units on a scale
Standard Deviation 2.05
|
PRIMARY outcome
Timeframe: 3-MonthPopulation: 31 participants from the Usual Care + PBM Group and 4 participants from the Usual Care + Sham (Placebo) PBM Group completed 3-month randomized followed up. 26 randomized participants from the Usual Care + Sham (Placebo) PBM Group crossed over at 6-week follow-up and received the study intervention.
Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=33 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=26 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
3.47 pain units on a scale
Standard Deviation 2.60
|
4.50 pain units on a scale
Standard Deviation 3.20
|
PRIMARY outcome
Timeframe: BaselinePlantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=34 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=35 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Ultrasound Measurement (Plantar Fascial Thickness)
|
4.18 millimeters
Standard Deviation 1.98
|
4.29 millimeters
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: 3-WeekPopulation: 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up.
Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=33 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Ultrasound Measurement (Plantar Fascial Thickness)
|
3.955 millimeters
Standard Deviation 1.24
|
4.375 millimeters
Standard Deviation 1.165
|
PRIMARY outcome
Timeframe: 6-WeekPopulation: 62 enrolled participants were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up.
Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=31 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=31 Participants
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Ultrasound Measurement (Plantar Fascial Thickness)
|
4.155 millimeters
Standard Deviation 1.825
|
4.665 millimeters
Standard Deviation 1.045
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-Week Cross-overThe FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
57.07 Percentage of function
Standard Deviation 14.88
|
—
|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
16.11 Percentage of function
Standard Deviation 7.92
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Week Cross-overThe FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
56.27 Percentage of function
Standard Deviation 17.32
|
—
|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
16.69 Percentage of function
Standard Deviation 8.88
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-Week Cross-overDefense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
3.11 units on a scale
Standard Deviation 2.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Week Cross-OverDefense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
|
3.50 units on a scale
Standard Deviation 2.34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-month Cross-overThe FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Sports (7-item)
|
16.11 Percentage of function
Standard Deviation 7.92
|
—
|
|
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (21- item)
|
57.00 Percentage of function
Standard Deviation 17.09
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-month Cross-overDefense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.
Outcome measures
| Measure |
The Usual Care + PBM Group
n=26 Participants
Participants that were assigned to this group received treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons.
|
|---|---|---|
|
Pain Diary and Veterans Pain Rating Scale (DVPRS)
|
3.65 units on a scale
Standard Deviation 2.40
|
—
|
Adverse Events
The Usual Care + PBM Group
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
The Usual Care + Sham (Placebo) PBM Group
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The Usual Care + PBM Group
n=31 participants at risk
Participants that were assigned to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=33 participants at risk
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time was calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage was warmed in the sham-PBMT. The device was turned on, so the red aiming beam will be visible, but the operator did not activate the switch to emit photons.
|
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
n=26 participants at risk
Participants that were decided to cross-over to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Arm Injury
|
3.2%
1/31 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/33 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
3.2%
1/31 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/33 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Musculoskeletal and connective tissue disorders
Fluid in the Foot
|
0.00%
0/31 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.0%
1/33 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.8%
1/26 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/31 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/33 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.8%
1/26 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Surgical and medical procedures
Hand Surgery
|
0.00%
0/31 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.0%
1/33 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
Other adverse events
| Measure |
The Usual Care + PBM Group
n=31 participants at risk
Participants that were assigned to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
The Usual Care + Sham (Placebo) PBM Group
n=33 participants at risk
Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment.
Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time was calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage was warmed in the sham-PBMT. The device was turned on, so the red aiming beam will be visible, but the operator did not activate the switch to emit photons.
|
The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention
n=26 participants at risk
Participants that were decided to cross-over to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.
Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size).
PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/31 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.0%
1/33 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Skin and subcutaneous tissue disorders
Skin reaction to unknown
|
0.00%
0/31 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
3.0%
1/33 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
|
Injury, poisoning and procedural complications
Scar from Dry Needling
|
3.2%
1/31 • Number of events 1 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/33 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
0.00%
0/26 • All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
|
Additional Information
Elizabeth Metzger, Scientific Program Manager
The Geneva Foundation
Phone: 253-383-1398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place