Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.

Official Title
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Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis

Conditions
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Arthritis Shoulder

Intervention / Treatment
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* Procedure: Glenohumeral Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥18y.o. of age Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation. Baseline pain level of VAS >4 Exclusion Criteria: Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis) Ipsilateral shoulder surgery within 1 year Any glenohumeral joint injection within 3 months Allergy to lidocaine Known pregnancy Workers compensation case regarding shoulder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid Injection Group<br>80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection | Procedure: Glenohumeral Injection<br>* Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.<br>|
| Active Comparator: Platelet-Rich Plasma Injection Group<br>15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP | Procedure: Glenohumeral Injection<br>* Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale-Pain (VAS) | Validated patient-reported metric scale of pain: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) | 12 weeks |