HYPOTHESIS

A randomized, double-blind, placebo-controlled study of sodium hyaluronate (ARTZ Dispo) treatment was performed in 51 patients with rotator cuff lesions without complete tears. We hypothesized that ARTZ Dispo would render better results than the placebo.

MATERIALS AND METHODS

Twenty-five patients (ARTZ Dispo group) had injections of 25 mg/wk of sodium hyaluronate into the subacromial bursa for 5 consecutive weeks. Twenty-six patients (placebo group) were given 2.5 mL of normal saline solution with the same injection protocol as the ARTZ Dispo group. No significant difference in age, height, weight, gender, vocation, involved shoulder, duration of symptoms, baseline Constant score, or visual analog scale (VAS) score existed between the 2 groups.

RESULTS

The 2 groups did not significantly differ with regard to Constant scores, VAS scores, or global improvement assessments 1 week after injections. The ARTZ Dispo group had a better Constant score (P = .0095) and VAS score (P = .0018) than the placebo group 6 weeks after treatment. Patients in the placebo group were given 5 sodium hyaluronate injections, rather than placebo, after disclosure of the blind list, if they wished. Forty-one patients who underwent hyaluronate injection exhibited a significantly improved Constant score, from 64.0 +/- 11.7 at baseline to 88.9 +/- 10.4 (P < .0001), and a significantly improved VAS score, from 6.4 +/- 1.3 to 1.5 +/- 1.6 (P < .0001), at a mean follow-up of 33.1 months. No significant adverse effect was noted.

CONCLUSIONS

Subacromial injections of sodium hyaluronate are effective in treating rotator cuff lesions without complete tears.