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Recruiting NCT04949087

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

No phase Interventional Arthritis Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glenohumeral Injection.
Who it may be relevant to
Registry conditions: Arthritis Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Visual Analog Scale-Pain (VAS) [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT04949087 · ORA 18060603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗