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

Arthritis Shoulder Clinical Trial

— GHOA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949087
• Other study ID #: ORA 18060603
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Rush University Medical Center
• Contact: Carla M Edwards, PhD
• Phone: 312.563.5735
• Email: carla_edwards[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis Shoulder
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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