Trial Outcomes & Findings for Platelet-Rich Plasma Therapy for Patellar Tendinopathy (NCT NCT03136965)
NCT ID: NCT03136965
Last Updated: 2023-10-26
Results Overview
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
baseline, 16 weeks, 32 weeks, 52 weeks
Results posted on
2023-10-26
Participant Flow
Participants were recruited from April 2017 to June 2021.
One person was consented and enrolled to the study, but post-imaging analysis, did not have patellar tendinopathy and did not fully onboard to study.
Participant milestones
| Measure |
Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Baseline characteristics by cohort
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Age, Customized
20-29 years old
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Customized
30-39 years old
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 16 weeks, 32 weeks, 52 weeksA quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Change in Measure of Pain Level: VISA-P Score
baseline
|
32.2 score on a scale
Standard Deviation 57.8
|
46.3 score on a scale
Standard Deviation 69.5
|
43.2 score on a scale
Standard Deviation 68.8
|
|
Change in Measure of Pain Level: VISA-P Score
16 weeks
|
52.5 score on a scale
Standard Deviation 78.1
|
56.9 score on a scale
Standard Deviation 82
|
53.7 score on a scale
Standard Deviation 79.4
|
|
Change in Measure of Pain Level: VISA-P Score
32 weeks
|
62.1 score on a scale
Standard Deviation 87.7
|
56.2 score on a scale
Standard Deviation 81.3
|
58.9 score on a scale
Standard Deviation 85.7
|
|
Change in Measure of Pain Level: VISA-P Score
52 weeks
|
64 score on a scale
Standard Deviation 89.6
|
55.6 score on a scale
Standard Deviation 83
|
60.3 score on a scale
Standard Deviation 87
|
PRIMARY outcome
Timeframe: baseline, 16 weeks, 32 weeks, 52 weeksThe Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Change in Measure of Activity Level: Tegner Activity Level Score
baseline
|
2.8 score on a scale
Standard Deviation 5.2
|
5 score on a scale
Standard Deviation 7.2
|
5.3 score on a scale
Standard Deviation 7.8
|
|
Change in Measure of Activity Level: Tegner Activity Level Score
16 weeks
|
3.5 score on a scale
Standard Deviation 6
|
4.5 score on a scale
Standard Deviation 6.9
|
4.6 score on a scale
Standard Deviation 7.1
|
|
Change in Measure of Activity Level: Tegner Activity Level Score
32 weeks
|
4.2 score on a scale
Standard Deviation 6.7
|
5.1 score on a scale
Standard Deviation 7.5
|
4.5 score on a scale
Standard Deviation 7
|
|
Change in Measure of Activity Level: Tegner Activity Level Score
52 weeks
|
4.8 score on a scale
Standard Deviation 7.3
|
5.2 score on a scale
Standard Deviation 7.9
|
4.5 score on a scale
Standard Deviation 7
|
PRIMARY outcome
Timeframe: baseline, 16 weeks, 32 weeks, 52 weeksParticipant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Change in Visual Analogue Scale (VAS) Pain Score
16 weeks
|
2.5 score on a scale
Standard Deviation 5.6
|
4.2 score on a scale
Standard Deviation 7.2
|
2.9 score on a scale
Standard Deviation 6
|
|
Change in Visual Analogue Scale (VAS) Pain Score
baseline
|
5.9 score on a scale
Standard Deviation 9
|
5.5 score on a scale
Standard Deviation 8.3
|
6.1 score on a scale
Standard Deviation 9.2
|
|
Change in Visual Analogue Scale (VAS) Pain Score
32 weeks
|
1.1 score on a scale
Standard Deviation 4.1
|
3.8 score on a scale
Standard Deviation 6.8
|
1.6 score on a scale
Standard Deviation 4.7
|
|
Change in Visual Analogue Scale (VAS) Pain Score
52 weeks
|
0 score on a scale
Standard Deviation 3.2
|
2.8 score on a scale
Standard Deviation 6.1
|
1.8 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: baseline, 16 weeks, 52 weeksPopulation: T2 signal intensity was not measured via MRI, rather MRI was used for exploratory measures using novel software as updated in the Other Pre-specified measures.
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 16 weeks, 52 weeksPopulation: MRI was not used to measure thickness, Ultrasound was used to assess thickness.
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 16 weeks, 52 weeksTo demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
16 weeks
|
6.5 millimeters
Standard Deviation 8.5
|
5.4 millimeters
Standard Deviation 7.3
|
7 millimeters
Standard Deviation 9.1
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
baseline
|
6.6 millimeters
Standard Deviation 8.6
|
5.2 millimeters
Standard Deviation 7.1
|
7 millimeters
Standard Deviation 9
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
52 weeks
|
6 millimeters
Standard Deviation 8
|
5.4 millimeters
Standard Deviation 7.4
|
5.7 millimeters
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: baseline, 16 weeks, 52 weeksTo demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe.
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
baseline
|
1.3 score on a scale
Standard Deviation 2.5
|
1.5 score on a scale
Standard Deviation 2.5
|
1.4 score on a scale
Standard Deviation 2.6
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
Change from Baseline at 16 weeks
|
1.3 score on a scale
Standard Deviation 2.5
|
1.3 score on a scale
Standard Deviation 2.4
|
1.9 score on a scale
Standard Deviation 3
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
Change from Baseline at 52 weeks
|
1.3 score on a scale
Standard Deviation 2.5
|
1.4 score on a scale
Standard Deviation 2.6
|
1.1 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: baseline, 16 weeks, 52 weeksTo demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases.
Outcome measures
| Measure |
Platelet-Rich Plasma (PRP)
n=10 Participants
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP)
|
Dry Needling Procedure
n=10 Participants
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
|
Sham Procedure
n=9 Participants
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
|
|---|---|---|---|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
baseline
|
1.1 score on a scale
Standard Deviation 2.5
|
0.6 score on a scale
Standard Deviation 1.8
|
1.4 score on a scale
Standard Deviation 2.8
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
Change from Baseline at 16 weeks
|
0.7 score on a scale
Standard Deviation 2
|
0.4 score on a scale
Standard Deviation 1.7
|
1.3 score on a scale
Standard Deviation 2.7
|
|
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
Change from Baseline at 52 weeks
|
0.4 score on a scale
Standard Deviation 1.8
|
-0.2 score on a scale
Standard Deviation 1.2
|
0.4 score on a scale
Standard Deviation 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 16 weeks, 52 weeksFlexor and extensor muscle strength will be measured with this device before and after the intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 52 weeksTo investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 16 weeks, 52 weeksExploratory MRI measure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 16 weeks, 52 weeksOutcome measures
Outcome data not reported
Adverse Events
Platelet-Rich Plasma (PRP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dry Needling Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Lee, MD, MBA
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-9387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place