Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial.

BACKGROUND: Rotator cuff disease is a common cause of shoulder pain. There are studies about the effectiveness of sodium hyaluronate injection on shoulder and knee pain, but few studies demonstrating the efficacy of sodium hyaluronate ultrasonography guided injection for rotator cuff disease. This study evaluates effectiveness of ultrasonography guided subacromial sodium hyaluronate injection in patients with impingment syndrome without rotator cuff complete tear.

MATERIALS AND METHODS: This prospective, double-blind, placebo controlled clinical trial study was performed among 40 patients with subacromial impingement syndrome without complete tear of rotator cuff. Patients randomly injected ultrasonography guided in 2 groups: Case group by 20 mg of sodium hyaluronate (Fermathron™) and control group by 0.9% normal saline. Both groups received 3 weekly injections. The pain score (100 mm visual analogue score [VAS]) was evaluated before first injection and one week after each injection. The constant score was evaluated before first and 12 week after last injection. Data was analyzed statistically by Independent t-test.

RESULTS: In both groups mean VAS has decreased, but more significantly in case group (P < 0.001). Mean constant score was significantly higher in case group 12 weeks after last injection (P < 0.001). The constant score improved 12 weeks after the last injection in both groups with a significantly better result in case group (P < 0.001).

CONCLUSION: Subacromial injections of sodium hyaluronate are effective in treating rotator cuff disease without complete tears.