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Open Access Research article

Intra-articular injections of sodium hyaluronate (Hyalgan®) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the asian population

Teng-Le Huang123, Chi-Ching Chang4, Chian-Her Lee5, Shih-Ching Chen6, Chien-Hung Lai7 and Ching-Lin Tsai8*

Author Affiliations

1 Department of Orthopaedic, China Medical University Hospital, No.2 Yu-Der Road, Taichung 404, Taiwan

2 Department of Sports Medicine, College of Health Care, China Medical University, No.91, Hsueh-Shih Road, Taichung, Taiwan 404, Taiwan

3 School of Medicine, College of Medicine, China Medial University, No.91, Hsueh-Shih Road, Taichung, Taiwan 404, Taiwan

4 Department of Medicine, Division of Rheumatology, Immunology, Allergy, Taipei Medical University Hospital, 250 Wu-Hsing Street, Taipei City 110, Taiwan

5 Department of Orthopaedic, Taipei Medical University Hospital, 250 Wu-Hsing Street, Taipei City 110, Taiwan

6 Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, 250 Wu-Hsing Street, Taipei City 110, Taiwan

7 Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, 250 Wu-Hsing Street, Taipei City 110, Taiwan

8 Department of Orthopaedic, National Taiwan University and University Hospital, 7 Chung Shan South Road, Taipei, Taiwan

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BMC Musculoskeletal Disorders 2011, 12:221  doi:10.1186/1471-2474-12-221

Published: 6 October 2011

Abstract

Background

The efficacy and tolerability of 500-730 kDa sodium hyaluronate (Hyalgan®) for treatment of osteoarthritis (OA) pain has been established in clinical trials, but few data are available in the Asian population. We conducted a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and tolerability of this preparation in a Taiwanese population.

Methods

Two hundred patients with mild to moderate OA of the knee were randomized to receive five weekly intra-articular injections of sodium hyaluronate or placebo. The primary efficacy outcome was the change from baseline to Week 25 in patients' evaluation of pain using a 100-mm visual analog scale (VAS) during the 50-foot walking test. Additional outcomes included Western Ontario and McMaster Universities (WOMAC) scores, time on the 50-foot walking test, patient's and investigator's subjective assessment of effectiveness, acetaminophen consumption, and the amounts of synovial fluid.

Results

The Hyalgan® treatment group showed a significantly greater improvement from baseline to Week 25 in VAS pain on the 50-foot walking test than the placebo group (p = 0.0020). The Hyalgan® group revealed significant improvements from baseline to week 25 in WOMAC pain and function score than the placebo group (p = 0.005 and 0.0038, respectively) Other outcomes, such as time on the 50-foot walking test and subjective assessment of effectiveness, did not show any significant difference between groups. Both groups were safe and well tolerated.

Conclusions

The present study suggests that five weekly intra-articular injections of sodium hyaluronate are well tolerated, can provide sustained relief of pain, and can improve function in Asian patients with osteoarthritis of the knee.

Level of Evidence

Therapeutic study, Level I-1a (randomized controlled trial with a significant difference).

Trial registration

ClinicalTrials.gov Identifier: NCT01319461