Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale-Pain (VAS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double-blinded, randomized
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Corticosteroid Injection Group
80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
Intervention: Glenohumeral Injection (Procedure)
Platelet-Rich Plasma Injection Group
15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP
Intervention: Glenohumeral Injection (Procedure)
Outcomes
Primary Outcomes
Visual Analog Scale-Pain (VAS)
Time Frame: 12 weeks
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)
Secondary Outcomes
No secondary outcomes reported