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

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.