Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

April 13, 2017 updated by: University of North Carolina, Chapel Hill

Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.

The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shoulder pain for at least two weeks.
  • Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound.

Exclusion Criteria:

  • Prior surgery to the injured shoulder
  • Full thickness rotator cuff tear
  • Pregnancy
  • Cancer
  • Current treatment with anticoagulation medication
  • Steroid injection in the past 6 months in the injured shoulder
  • Prior PRP treatment to the injured shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelet-rich plasma protein (PRP)
Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.
Biological: Platelet Rich Plasma (PRP)
Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.
Active Comparator: Corticosteroid
Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.
Drug: Corticosteroid

Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site.

For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site.

Other Names:
  • Dexamethasone
  • Bupivacaine
  • Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Time Frame: baseline and one year
Disabilities of the Arm, Shoulder, and Hand (DASH) is a 30-item self-reported questionnaire used assess shoulder function. The DASH is widely used in orthopaedic research and is considered valid and reliable.
baseline and one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)
Time Frame: baseline six weeks, 3 months, 6 months
baseline six weeks, 3 months, 6 months
Percent change in Visual Analog Pain scale (VAS)
Time Frame: Baseline, six weeks, three months, six months, one year
Visual Analog Pain scale (VAS) is a self-reported questionnaire used to measure a patients pain level on a scale from 0 (no pain) to 10 (extreme pain).
Baseline, six weeks, three months, six months, one year
Percent change in American Shoulder and Elbow Surgeons (ASES) scale
Time Frame: Baseline, six weeks, three months, six months, one year
American Shoulder and Elbow Surgeons (ASES) scale is used to measure shoulder function. It is combines both physician assessment and patient self-reported questionnaire date to create the functional score.
Baseline, six weeks, three months, six months, one year
Size of rotator cuff tear size.
Time Frame: Baseline, six months and one year
Rotator cuff tear size will be determined using ultrasound imaging. The mean size at six months and one year will be compared to baseline per-treatment size.
Baseline, six months and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Brendan C Mackinnon-Patterson, BS, MPH, MD, University of North Carolina Department of Orthopaedics
  • Study Director: Berkoff David, MD, University of North Carolina Department of Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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