The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Constant-Murley shoulder score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Platelet-Rich Plasma Protein (PRP) Group
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Intervention: Platelet-Rich Plasma (Biological)
Platelet-Rich Plasma Protein (PRP) Group
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Intervention: Exercise (Other)
Hyaluronic Acid Group
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
Intervention: Hyaluronic Acid (Drug)
Hyaluronic Acid Group
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
Intervention: Exercise (Other)
Outcomes
Primary Outcomes
Constant-Murley shoulder score
Time Frame: Change is measured from baseline to 1.5 and 3 months
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.
Secondary Outcomes
- Size of rotator cuff tear(Change is measured from baseline to 1.5 and 3 months)
- Numeric Pain Rating Scale(Change is measured from baseline to 1.5 and 3 months)
- Shoulder Pain and Disability Index (SPADI)(Change is measured from baseline to 1.5 and 3 months)
- Shoulder range of motion(Change is measured from baseline to 1.5 and 3 months)