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

Taipei Veterans General Hospital

Status and phase: Completed; Phase 1

Conditions: Rotator Cuff Tear

Treatments: Other: Exercise; Biological: Platelet-Rich Plasma; Drug: Hyaluronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03548662

2014-02-005B

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Platelet-Rich Plasma Protein (PRP) Group

Experimental group

Description:

Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise

Treatment:

Other: Exercise

Biological: Platelet-Rich Plasma

Hyaluronic Acid Group

Active Comparator group

Description:

Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise

Treatment:

Drug: Hyaluronic Acid

Other: Exercise