Sodium hyaluronate for the treatment of chronic shoulder pain associated with
glenohumeral osteoarthritis: a multicenter, randomized, double-blind,
placebo-controlled trial.
Author(s): Kwon YW, Eisenberg G, Zuckerman JD.
Affiliation(s): Division of Shoulder and Elbow Surgery, Department of Orthopaedic Surgery, NYU
Hospital for Joint Diseases, New York, NY, USA. Electronic address:
young.kwon@nyumc.org.
Publication date & source: 2013, J Shoulder Elbow Surg. ,
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.
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