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

Phase 1

Terminated

• Conditions: Rotator Cuff Tear
• Interventions: Drug: Corticosteroid; Biological: Platelet Rich Plasma (PRP)

• Registration Number: NCT01688362
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Study Start: 2012-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-02
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Corticosteroid	Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.
platelet-rich plasma protein (PRP)	Platelet Rich Plasma (PRP)	Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.

Primary Outcome Measures

Name	Time	Method
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)	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.

Secondary Outcome Measures

Name	Time	Method
Percent change in American Shoulder and Elbow Surgeons (ASES) scale	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.
Percent change in Disabilities of the Arm, Shoulder, and Hand score. (DASH)	baseline six weeks, 3 months, 6 months
Percent change in Visual Analog Pain scale (VAS)	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).
Size of rotator cuff tear size.	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.

Trial Locations

Locations (1)

University of North Carolina Department of Orthopaedics; 🇺🇸 Chapel Hill, North Carolina, United States