Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

Study Overview
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Brief Summary
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The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.

Official Title
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Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.

Conditions
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Rotator Cuff Tear

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Shoulder pain for at least two weeks. Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound. Exclusion Criteria: Prior surgery to the injured shoulder Full thickness rotator cuff tear Pregnancy Cancer Current treatment with anticoagulation medication Steroid injection in the past 6 months in the injured shoulder Prior PRP treatment to the injured shoulder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet-rich plasma protein (PRP)<br>Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks. | Biological: Platelet Rich Plasma (PRP)<br>* Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.<br>|
| Active Comparator: Corticosteroid<br>Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. | Drug: Corticosteroid<br>* Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site. For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) | Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable. | baseline and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH) |  | baseline six weeks, 3 months, 6 months | 
| Percent change in Visual Analog Pain scale (VAS) | Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain). | Baseline, six weeks, three months, six months, one year | 
| Percent change in American Shoulder and Elbow Surgeons (ASES) scale | American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score. | Baseline, six weeks, three months, six months, one year | 
| Size of rotator cuff tear size. | Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size. | Baseline, six months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective Randomized Controlled Double Blinded Trial, Rotator Cuff Tear, Platelet Rich Plasma, Corticosteroid, Ultrasound