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Treatment of Persistent Shoulder Pain with Sodium Hyaluronate: A Randomized, Controlled Trial

A Multicenter Study

¹ Brown Alpert Medical School, Rhode Island Shoulder and Elbow Service, University Orthopedics, 2 Dudley Street, Providence, RI 02901. E-mail address: Theodore_Blaine{at}Brown.edu
² Department of Medicine, Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106. E-mail address: Roland.moskowitz{at}uhhs.com
³ The Arthritis Group, 7908 Bustleton Avenue, Philadelphia, PA 19152
⁴ CORE Orthopaedic Medical Center, 332 Santa Fe Drive, Suite 110, Encinitas, CA 92024
⁵ Mease Medical Arts—Dunedin, 1056 Virginia Street, 4th Floor, Dunedin, FL 34698
⁶ 8451 Shade Avenue, #108, Sarasota, FL 34243
⁷ One Battery Park, New York, NY 10016
⁸ 9854 West Bald Mountain Court, Agua Dulce, CA 91390

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from sanofi-aventis. In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (sanofi-aventis). Also, a commercial entity (sanofi-aventis) paid or directed in any one year, or agreed to pay or direct, benefits of less than $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.

Methods: Six hundred and sixty patients with persistent shoulder pain and limitation resulting from glenohumeral joint osteoarthritis, rotator cuff tear, and/or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind, randomized, phosphate-buffered saline solution-controlled study, and 456 patients completed twenty-six weeks of follow-up. Patients were randomized to receive either five weekly intra-articular injections of sodium hyaluronate, three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution, or five weekly intra-articular injections of saline solution. The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment (as assessed with use of a 100-mm visual analog scale) and the treatment effect throughout twenty-six weeks.

Results: For the overall intent-to-treat population, patients who were managed with sodium hyaluronate had greater pain relief than controls did; significant differences were noted at Week 7 (for the five-injection hyaluronate group), Week 17 (for the three and five-injection hyaluronate groups), and Week 26 (for the three-injection hyaluronate group). Analysis of the stratified populations clearly established that this effect was due to benefits experienced by the patients with osteoarthritis. The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection (p = 0.003) and five-injection (p = 0.002) groups, with no significant difference for either regimen in patients without osteoarthritis. The safety profile was very favorable, with no product-related serious adverse effects and no between-group differences for any reported adverse event.

Conclusions: Although the primary end point of this study (that is, improvement in terms of shoulder pain at thirteen weeks) was not achieved, the overall findings, including secondary end points, indicate that sodium hyaluronate (500 to 730 kDa) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other standard nonoperative interventions.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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