Clinical evaluation of sodium hyaluronate for the treatment of patients with rotator cuff tear.

A randomized study of two types of conservative treatment of 78 shoulders in 78 patients with rotator cuff tears was performed. Twenty-five milligrams of sodium hyaluronate (SH) was injected into shoulders in one group (SH group) and 2 mg of dexamethasone was injected in the other group (steroid group). Injection of each drug was planned for once per week for 5 consecutive weeks. In the SH group, University of California at Los Angeles score before treatment was 13.6 +/- 2.6 points in 16 patients who did not require surgery (satisfied patients) and 12.8 +/- 3.5 points in 22 patients who required surgery (unsatisfied patients) (not statistically significant). In the steroid group, University of California at Los Angeles score before treatment was 11.9 +/- 3.6 points for 15 satisfied patients and 12.6 +/- 3.9 points for 25 unsatisfied patients (again, not statistically significant). In the SH group, the score at 4 weeks after treatment for satisfied patients increased to 27.6 +/- 3.1 points, whereas that for unsatisfied patients was 14.9 +/- 1.2 points (P <.0001). Similarly, in the steroid group, the score at 4 weeks after the treatment for satisfied patients increased to 26.5 +/- 2.0 points, whereas that for unsatisfied patients was 15.0 +/- 4.0 points (P <.0001). At 24 weeks after treatment, the score for satisfied patients was 26.2 +/- 3.1 points in the SH group and 25.3 +/- 2.5 points in the steroid group. The effective rate of the SH group was 39.5% and that of the steroid group was 35%. Therapeutic efficacy in the SH group was equivalent to that in the steroid group. In both groups, the rate of patients who engaged in manual labor was significantly higher in the group of unsatisfied patients than in that of satisfied patients. No adverse reaction to either treatment was observed. These results suggest that SH is an effective conservative treatment for patients with rotator cuff tears.

RCT Entities:   Population Interventions Outcomes