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

Sponsor

Rush University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04949087

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Shoulder	Procedure: Glenohumeral Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double-blinded, randomized

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Corticosteroid Injection Group 80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection	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.
Active Comparator: 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	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.

Arm

Intervention/Treatment

Experimental: Corticosteroid Injection Group

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

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.

Active Comparator: 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

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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

Informed Consent Form - Jul 30, 2020

More Information

Publications

None provided.

Responsible Party:

Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT04949087

Other Study ID Numbers:

ORA 18060603

First Posted:

Jul 2, 2021

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Jun 27, 2022