Platelet-Rich Plasma Therapy for Patellar Tendinopathy

Study Overview
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Brief Summary
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The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.

Detailed Description
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Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.

Official Title
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Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers

Conditions
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Patellar Tendinitis

Intervention / Treatment
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* Biological: PRP
* Procedure: Dry Needling
* Procedure: Dry Needling - Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 39 years Chronic (>3 months) PT Clinical examination consistent with PT MRI or US confirmation of PT Pain score of 3 or greater on a 10-point visual analogue scale Self-report failure of supervised physical therapy Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing). Exclusion Criteria: Inability to comply with study follow-up requirements History of bleeding disorders or other hematologic conditions Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction) Full or partial patellar tendon tear Current use of anticoagulation or immunosuppressive therapy Prior knee trauma requiring medical attention or surgery Worker's compensation injury Daily opioid use for pain Contraindication to MRI. Systemic diseases such as Diabetes and connective tissue diseases. Prior PRP or DN procedure. Women that are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma (PRP)<br>Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP. | Biological: PRP<br>* Injection of autologous platelet rich plasma (PRP)<br>|
| Placebo Comparator: Dry Needling Procedure<br>Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection. | Procedure: Dry Needling<br>* 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.<br>|
| Sham Comparator: Sham Procedure<br>Group 3 (sham) will undergo US-guided sham dry needling procedure. | Procedure: Dry Needling - Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Measure of Pain Level: VISA-P Score | 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. | baseline, 16 weeks, 32 weeks, 52 weeks | 
| Change in Measure of Activity Level: Tegner Activity Level Score | The 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. | baseline, 16 weeks, 32 weeks, 52 weeks | 
| Change in Visual Analogue Scale (VAS) Pain Score | Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain). | baseline, 16 weeks, 32 weeks, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures. | baseline, 16 weeks, 52 weeks | 
| MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures. | baseline, 16 weeks, 52 weeks | 
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. | baseline, 16 weeks, 52 weeks | 
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | To 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. | baseline, 16 weeks, 52 weeks | 
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | To 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. | baseline, 16 weeks, 52 weeks |