Platelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)
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|ClinicalTrials.gov Identifier: NCT03136965|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Patellar Tendinitis||Biological: PRP Procedure: Dry Needling Procedure: Dry Needling - Sham||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blinded randomized controlled trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.|
|Official Title:||Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers|
|Actual Study Start Date :||April 25, 2017|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Injection of autologous platelet rich plasma (PRP)
Placebo Comparator: Dry Needling Procedure
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Procedure: 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 Comparator: Sham Procedure
Group 3 (sham) will undergo US-guided sham dry needling procedure.
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.
- Measure of pain level [ Time Frame: 52 weeks ]A quality of life measure, the VISA-P will be used to evaluate pain before and after the intervention.
- Measure of activity level [ Time Frame: 52 weeks ]A quality of life measure, the VISA-P will be used to evaluate activity level before and after the intervention.
- MRI Scan To demonstrate treatment-related changes in pathologic imaging features of PT (thickness and T2 signal intensity). [ Time Frame: 52 weeks ]To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
- Ultrasound Scan to demonstrate treatment-related changes in pathologic imaging features of PT (thickness, echogenicity, and hyperemia) [ Time Frame: 52 weeks ]To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
- Isokinetic Dynamometer measure of flexor and extensor muscle strength before and after the intervention [ Time Frame: 52 weeks ]Flexor and extensor muscle strength will be measured with this device before and after the intervention.
- Relationship between changes in novel quantitative MRI and US parameters of PT and clinical and biomechanical improvement following treatment. [ Time Frame: 52 weeks ]To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136965
|Contact: Gemma Gliori, MSemail@example.com|
|Contact: Suzanne Hanson, BSfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin, Madison||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator: Kenneth Lee, MD|
|Principal Investigator:||Kenneth Lee, MD||University of Wisconsin, Madison|