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

University of North Carolina (UNC)

Status and phase: Terminated; Phase 1

Conditions: Rotator Cuff Tear

Treatments: Drug: Corticosteroid; Biological: Platelet Rich Plasma (PRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01688362

12-1016

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

platelet-rich plasma protein (PRP)

Experimental group

Description:

Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.

Treatment:

Biological: Platelet Rich Plasma (PRP)

Corticosteroid

Active Comparator group

Description:

Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.

Treatment:

Drug: Corticosteroid