Abstract | BACKGROUND: Presently, there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain. Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain resulting from various etiologies. The present study evaluated the efficacy and safety of sodium hyaluronate (Hyalgan; molecular weight, 500 to 730 kDa) for these patients. METHODS: 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.
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Authors | Theodore Blaine, Roland Moskowitz, James Udell, Michael Skyhar, Robert Levin, Jeffrey Friedlander, Michael Daley, Roy Altman |
Journal | The Journal of bone and joint surgery. American volume
(J Bone Joint Surg Am)
Vol. 90
Issue 5
Pg. 970-9
(May 2008)
ISSN: 1535-1386 [Electronic] United States |
PMID | 18451387
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adjuvants, Immunologic
- Hyaluronic Acid
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Topics |
- Adjuvants, Immunologic
(adverse effects, therapeutic use)
- Adult
- Aged
- Double-Blind Method
- Female
- Humans
- Hyaluronic Acid
(adverse effects, therapeutic use)
- Injections, Intra-Articular
- Male
- Middle Aged
- Osteoarthritis
(complications)
- Range of Motion, Articular
- Safety
- Shoulder Pain
(drug therapy, etiology)
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