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

NCT04949087 | Recruiting DMC

• 1 other identifier: ORA 18060603
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Shoulder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Corticosteroid Injection Group

EXPERIMENTAL

80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection

Procedure: Glenohumeral Injection

Platelet-Rich Plasma Injection Group

ACTIVE COMPARATOR

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

Interventions

Glenohumeral Injection PROCEDURE

Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.

Corticosteroid Injection Group; Platelet-Rich Plasma Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Central Study Contacts

Carla M Edwards, PhD

CONTACT

312.563.5735; carla_edwards@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded, randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: July 2, 2021
• Study Start: March 13, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)