Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study

Background: This study assessed the hypothesis that injection of high-molecular weight hyaluronate in the treatment of subacromial impingement syndrome is effective and safe, compared with corticosteroid injection in the shoulder joint. Methods: One hundred five patients were allocated randomly into 2 groups: 1 group was injected once a week for 3 weeks with hyaluronate and the other group was injected once with corticosteroid. All injections were guided to the subacromial space by an ultrasonogram. Eighty patients were followed up for 12 weeks after the injection: 38 patients in the hyaluronate group and 42 patients in the corticosteroid group. The functional outcome was measured using the American Shoulder and Elbow Surgeons standardized shoulder assessment form (ASES). Results: The Visual Analogue Scale (VAS) score at 12 weeks was decreased significantly from 58.6 +/- 19.3 to 24.6 +/- 23.1 in the hyaluronate group (P < .0001) and from 57.2 +/- 19.9 to 36.9 +/- 26.5 (P < .0001) in the corticosteroid group. There was a significant difference in the VAS score between the hyaluronic acid group and corticoid group (P = .0180) at 12 weeks. The functional ASES scores in the hyaluronate and corticosteroid groups were increased from 17.6 +/- 4.8 to 22.4 +/- 6.5 and from 17.3 +/- 4.9 to 21.7 +/- 5.8, respectively, at 12 weeks (P = .4825). There was no difference in the number of patients requiring rescue medication between the hyaluronate group and corticosteroid group at 12 weeks (P = .9254). Conclusion: A subacromial hyaluronate injection to treat impingement syndrome produces similar pain and functional improvement to corticosteroid at a short-term follow-up.