The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.

Detailed Description
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We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.

Official Title
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The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Biological: Platelet Rich Plasma (PRP)
* Drug: Corticosteroid (CS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing symptomatic for minimum of 3 months patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections) Exclusion Criteria: prior surgical intervention on affected shoulder full thickness rotator cuff tear concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis) confounding cervical neck pain or radiculopathy more than 3 previous CS injections a CS injection within 6 months of study intervention elite level athlete worker's compensation case litigation or secondary gain issues unwilling or unable to provide informed consent or complete study outcomes

Ages Eligible for Study
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Minimum Age: 18 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: Two arm parallel randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma (PRP)<br>Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection. | Biological: Platelet Rich Plasma (PRP)<br>* RegenLab, Lausanne, Switzerland<br>|
| Active Comparator: Corticosteroid (CS)<br>Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself. | Drug: Corticosteroid (CS)<br>* 40mg/ml triamcinolone in 2 ml 0.5% bupivicaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | visual analog scale for pain | change from baseline at 6 weeks, 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons shoulder score (ASES) | ASES score | change from baseline at 6 weeks, 3 months, 12 months | 
| Western Ontario Rotator Cuff Index (WORC) | WORC score | change from baseline at 6 weeks, 3 months, 12 months | 
| Failure | 1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery | anytime from injection out to 12 months | 
| Anatomic changes | ultrasound evidence of progression to a full thickness tear | 3 months and 12 months post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear