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

Partial Tear of Rotator Cuff Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02246530
• Other study ID #: F131231006
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 2021

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Partial Tear of Rotator Cuff
• Rotator Cuff Injuries
• Tendinopathy
• Tendinopathy of Rotator Cuff

Intervention

Procedure:
• PRP injection into PTRCT
Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury. PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.

Drug:
• Subacromial steroid bursal injection
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound

Locations

Country	Name	City	State
United States	UAB Highlands	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Ultrasound	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.	6 months post procedure
Secondary	Shoulder Pain and Disability Index	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.	Week 3 post procedure SPADI Scores for the control and treatment groups.
Secondary	Shoulder Pain and Disability Index	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.	Week 6 post procedure SPADI Scores for the treatment and control groups.
Secondary	Shoulder Pain and Disability Index	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.	6 months post procedure SPADI scores for the treatment and control groups.