Sodium hyaluronate for the treatment of chronic shoulder pain associated with glenohumeral osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Nonoperative treatments for glenohumeral osteoarthritis (GH-OA) are limited. Intra-articular therapy with sodium hyaluronate (HA) has been effective in treating OA of the knee. Therefore, we sought to evaluate the efficacy and safety of HA in treating chronic pain associated with GH-OA.

METHODS: This double-blind, randomized, controlled multicenter trial enrolled 300 patients with GH-OA: 150 received HA and 150 received phosphate-buffered saline (PBS) in 3 weekly injections and were evaluated over 26 weeks. Primary and secondary outcome measurements were visual analog scale (VAS) for pain and the percentage of Outcome Measures in Rheumatoid Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) high responders.

RESULTS: In HA and PBS intent-to-treat (ITT) patients, there was a mean improvement from baseline in VAS of 19.88 mm and 16.29 mm at week 26, respectively. Similarly, the percentage of OMERACT-OARSI high responders in the HA group was higher (40.8% vs 34.9%); however, neither difference was statistically significant (P = .1121 and P = .0690, respectively). In a subset of patients without concomitant shoulder pathologies, the differences of VAS and OMERACT-OARSI high-responder rates between groups were 4.0 mm and 8.37%, respectively, which reached statistical significance. Safety analyses showed comparable rates of adverse events between groups, and neither group reported serious treatment-related adverse events.

CONCLUSIONS: A numeric advantage, but without statistical significance, was found for HA ITT patients with GH-OA. Although data for a subset of HA patients without concomitant pathologies reached statistical significance, additional randomized trials are needed to confirm the clinical implication of this outcome.