Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients into low, medium, and high dose groups of injectable corticosteroids as these doses are typically used in the standard of care for our patients. To date there has been no study to evaluate which dose is most efficient with the fewest side effects for glenohumeral osteoarthritis. The investigators objective will be to provide ultrasound guided intraarticular glenohumeral injections of these randomized concentrations and to evaluate pain and function before and following injection with the Shoulder Pain and Disability Index (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent improvement of the pain and function to the medium and high doses, while minimizing side effects.


Clinical Trial Description

Osteoarthritis (OA) affects 54.4 million US adults and 23.7 million (43.5%) have arthritis-attributable activity limitation. As the condition progresses, pain and functional disability increase. Patients usually begin treatment with conservative measures including physical therapy and administration of nonsteroidal anti-inflammatory drugs before obtaining a corticosteroid injection. Corticosteroid injections have a patient-specific duration that often provide relief for a month before the effects begin to taper with most individuals returning to baseline by 2-3 months post injection. Unfortunately, data on intraarticular injections is not robust and primarily focused on hip, knee, and disease processes rather than the glenohumeral joint. For example, steroid concentrations have been studied in adhesive capsulitis, where 20 and 40mg of triamcinolone acenotide were used with no statistical significance between the two. When a placebo was added, both doses were better than the placebo, but once again no difference was seen between the two steroid concentrations. Another study, looking at knee osteoarthritis, found that high dose steroids had a larger effect on duration, but other studies have shown no difference in duration between the 40mg and 80mg concentration of triamcinolone acetonide. Intraarticular injections do have adverse effects. Similar to steroids taken orally or intravenously, intraarticular injections have a similar side effect profile. Fortunately, intraarticular injections are localized, by the nature of the procedure, and the chances of experiencing a significant side effect is rare. The most common side effects are steroid flare, allergic reaction, facial erythema, hypo-pigmentation, fat pad necrosis, cutaneous atrophy, and a transient increase in blood glucose. Some of the rare side effects have been seen in case reports include idiopathic central serous chorioretinopathy, decrease in breast milk production, sepsis, tendon rupture, and cataracts. In addition, the administration of steroid injections are limited to being done every three months due to risk of weakening tendons, and acceleration of cartilage loss. There is a void of literature for understating the ideal injectable steroid concentrations in glenohumeral osteoarthritis. Because of this, providers who perform intraarticular injections tend to perform them based on prior training experience or anecdotal evidence. We aim to evaluate the ideal steroid concentration that will maximize treatment effect for glenohumeral osteoarthritis, but at the same time minimize side effects, and better train our future providers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03586687
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Terminated
Phase Phase 4
Start date July 13, 2018
Completion date September 28, 2021

See also
  Status Clinical Trial Phase
Completed NCT01726972 - A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Completed NCT06043544 - Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis: Phase 4
Recruiting NCT05847062 - Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty. N/A
Recruiting NCT04105478 - Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis N/A
Recruiting NCT03866330 - Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis Phase 1/Phase 2
Recruiting NCT04845074 - Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis N/A
Completed NCT03379545 - 3D MR Versus 3D CT for Glenohumeral Arthritis N/A
Recruiting NCT06269705 - ZILRETTA in Subjects With Glenohumeral Osteoarthritis Phase 3
Active, not recruiting NCT06171542 - Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis Phase 1
Completed NCT00436969 - ORTHOVISC Shoulder Osteoarthritis Study Phase 3
Recruiting NCT03869229 - Adipose-derived Mesenchymal Stem Cells in Osteoarthritis Phase 1/Phase 2
Completed NCT00500630 - Objective Evaluation of Shoulder Pathology and Surgery N/A