The most effective corticosteroid dose in the treatment of glenohumeral osteoarthritis: Feasibility pilot and protocol for double blinded randomized controlled trial

Abstract

Objective

Osteoarthritis affects over 5.4 million people in the United States. A common treatment is to perform intra-articular corticosteroid injections. However, the ideal steroid dose is unknown. This study aimed to pilot a corticosteroid injection protocol for primary glenohumeral OA.

Methods

We conducted a double blinded randomized feasibility pilot study. Patients with primary osteoarthritis of the glenohumeral joint were recruited and randomized to receive 20 ​mg, 40 ​mg, or 80 ​mg of triamcinolone. The primary outcome was the feasibility of the protocol and change in the Shoulder Pain and Disability Index (SPADI) 6 months following injection.

Results

300 patients were screened for participation with 78 meeting inclusion criteria. 19 subjects completed the study. The most common reason for not participating was concern they would receive a smaller dose than previous injections. There was a 26% dropout rate, with 2 patients undergoing a total shoulder arthroplasty. There was no clinically significant difference (p ​= ​0.090) between the groups at 6-months for the SPADI although all treatment groups showed a reduction of SPADI from baseline at 6 months. There was one adverse event in the 20 ​mg group, with a patient experiencing facial flushing after the injection.

Conclusion

We were successful in developing a feasible protocol. In the future excluding those who have received previous injections would be helpful for a higher enrollment rate. This patient concern highlights the need to complete clinical trials to guide medical decisions surrounding corticosteroid administration. NCT03586687.