Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma

Not Applicable

Terminated

• Conditions: Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff
• Interventions: Procedure: PRP injection into PTRCT; Drug: Subacromial steroid bursal injection

• Registration Number: NCT02246530
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.

Detailed Description

Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Primary Completion: 2021-01
• Study Completion: 2021-03
• Results First Submitted: 2022-02-07
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-12
• Results First Posted: 2022-05-16
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. subjects between ages 19 to 75, both male and female
2. radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears
3. Failed a trial of physical therapy of at least 4 weeks

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Exclusion Criteria

1. Full thickness tears (well documented need for surgical correction)
2. sensory or neurologic complaint affecting the shoulder of interest
3. Coagulation disorder, platelet disorder
4. Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
5. Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
6. Prior surgery to either cervical spine or shoulder
7. Active military
8. Injury part of worker compensation claim

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP injection into PTRCT	PRP injection into PTRCT	Treatment - PRP injection
Subacromial steroid bursal injection	Subacromial steroid bursal injection	Current standard of care for treatment of resistant partial thickness rotator cuff tears

Primary Outcome Measures

Name	Time	Method
Diagnostic Ultrasound	6 months post procedure	Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.; Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index	6 months post procedure SPADI scores for the treatment and control groups.	Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.; In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.; 2 participants in the control (corticosteroid injection) group completed the study.

Trial Locations

Locations (1)

UAB Highlands; 🇺🇸 Birmingham, Alabama, United States