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

Not Applicable

Recruiting

• Conditions: Arthritis Shoulder
• Interventions: Procedure: Glenohumeral Injection

• Registration Number: NCT04949087
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Study Start: 2023-03-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid Injection Group	Glenohumeral Injection	80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
Platelet-Rich Plasma Injection Group	Glenohumeral Injection	15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale-Pain (VAS)	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)

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States