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

Phase 1

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Biological: Platelet-Rich Plasma; Drug: Hyaluronic Acid; Other: Exercise

• Registration Number: NCT03548662
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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 Timeline

• Study Start: 2014-03-04
• Study First Submitted: 2017-10-10
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-06
• Last Update Submitted: 2018-06-06
• Study First Posted: 2018-06-07
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-Rich Plasma Protein (PRP) Group	Platelet-Rich Plasma	Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Platelet-Rich Plasma Protein (PRP) Group	Exercise	Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Hyaluronic Acid Group	Exercise	Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
Hyaluronic Acid Group	Hyaluronic Acid	Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise

Primary Outcome Measures

Name	Time	Method
Constant-Murley shoulder score	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 Outcome Measures

Name	Time	Method
Size of rotator cuff tear	Change is measured from baseline to 1.5 and 3 months	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.
Numeric Pain Rating Scale	Change is measured from baseline to 1.5 and 3 months	The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable
Shoulder Pain and Disability Index (SPADI)	Change is measured from baseline to 1.5 and 3 months	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).
Shoulder range of motion	Change is measured from baseline to 1.5 and 3 months	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.

Trial Locations

Locations (1)

Taipei veteran general hospital; 🇨🇳 Taipei, Taiwan