The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear

Study Overview
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Brief Summary
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This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.

Detailed Description
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The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.

Official Title
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The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Biological: Platelet-Rich Plasma
* Drug: Hyaluronic Acid
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 and 85 years old, without significant cognition impairment (MMSE>20) Shoulder pain score(NRS)> 5 Partial tear of supraspinatus tendon, proved by ultrasonography or MRI Patients who signed informed consent Patients who agreed to stop using analgesics during the experimental period Exclusion Criteria: Thrombocytopenia (platelets less than 15000 per microliter) Patient who is using anticoagulant or has history of coagulation dysfunction Uncontrolled infection End stage malignant disease Infection or other skin condition over injection site History of shoulder or humeral fracture, dislocation or operation Psychiatric problems that precludes informed consent or inability to read or write Other serious problems that preclude participation of the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-Rich Plasma Protein (PRP) Group<br>Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise | Biological: Platelet-Rich Plasma<br>* Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA<br>* Other names: RegenKit® PRP;Other: Exercise<br>* passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise<br>|
| Active Comparator: Hyaluronic Acid Group<br>Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise | Drug: Hyaluronic Acid<br>* Hyruan Plus Inj. produced by LG Life Sciences, Ltd.<br>* Other names: Hyruan Plus Inj.;Other: Exercise<br>* passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley shoulder score | The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100. | Change is measured from baseline to 1.5 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable | Change is measured from baseline to 1.5 and 3 months | 
| Shoulder range of motion | The shoulder range of motion (ROM) is measured in both active and passive manner and in four direction including flexion, extension, internal rotation and external rotation. | Change is measured from baseline to 1.5 and 3 months | 
| Shoulder Pain and Disability Index (SPADI) | SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. The scores from both domains are averaged to derive a total score with 0 being the best outcome (less disability) and 100 the worst (greater disability). | Change is measured from baseline to 1.5 and 3 months | 
| Size of rotator cuff tear | Rotator cuff tear size will be determined using ultrasound imaging. The image will be conducted in sagittal plan, transverse plan and will measure the maximal size of tear. | Change is measured from baseline to 1.5 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tear, Platelet Rich Plasma, Ultrasound, Exercise, Hyaluronic Acid