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

Primary Purpose

Partial Tear of Rotator Cuff, Tendinopathy of Rotator Cuff

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRP injection into PTRCT
Subacromial steroid bursal injection
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Tear of Rotator Cuff

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB Highlands

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PRP injection into PTRCT

Subacromial steroid bursal injection

Arm Description

Treatment - PRP injection

Current standard of care for treatment of resistant partial thickness rotator cuff tears

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 21, 2014
Last Updated
May 12, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02246530
Brief Title
Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Official Title
Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study terminated prematurely due to inability to complete recruitment of subjects for each of the trial groups (treatment and control).
Study Start Date
July 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Tear of Rotator Cuff, Tendinopathy of Rotator Cuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP injection into PTRCT
Arm Type
Active Comparator
Arm Description
Treatment - PRP injection
Arm Title
Subacromial steroid bursal injection
Arm Type
Active Comparator
Arm Description
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Intervention Type
Procedure
Intervention Name(s)
PRP injection into PTRCT
Other Intervention Name(s)
Biologics
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Subacromial steroid bursal injection
Other Intervention Name(s)
Procedure
Intervention Description
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
Primary Outcome Measure Information:
Title
Diagnostic Ultrasound
Description
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.
Time Frame
6 months post procedure
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index
Description
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.
Time Frame
Week 3 post procedure SPADI Scores for the control and treatment groups.
Title
Shoulder Pain and Disability Index
Description
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.
Time Frame
Week 6 post procedure SPADI Scores for the treatment and control groups.
Title
Shoulder Pain and Disability Index
Description
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.
Time Frame
6 months post procedure SPADI scores for the treatment and control groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects between ages 19 to 75, both male and female 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 Failed a trial of physical therapy of at least 4 weeks Exclusion Criteria: Full thickness tears (well documented need for surgical correction) sensory or neurologic complaint affecting the shoulder of interest Coagulation disorder, platelet disorder Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy Prior surgery to either cervical spine or shoulder Active military Injury part of worker compensation claim
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Breanna Willeford, DO
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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