Abstract
OBJECTIVE: Shoulder tendinitis and subacromial bursitis are acute, painful inflammatory musculoskeletal conditions that may recur as a result of overuse. We investigated the efficacy of celecoxib in managing patients with acute shoulder tendinitis/bursitis. METHODS: In this double blind, placebo controlled, parallel group study, patients with acute onset shoulder tendinitis and/or subacromial bursitis were randomized to receive one of: celecoxib 400 mg followed by 200 mg bid, naproxen 500 mg bid, or placebo bid for 14 days. The primary measure of efficacy was the mean reduction in Maximum Pain Intensity at Rest, measured using a 100 mm visual analog scale, from baseline to Days 7 and 14. RESULTS: Of the 306 patients randomized to treatment, 254 completed the study. On Day 7, the mean reduction from baseline in Maximum Pain Intensity at Rest was significantly greater in the celecoxib group compared with the placebo group (-27.7 +/- 2.75 mm vs -18.4 +/- 2.63 mm, respectively; p < 0.05). Similarly, on Day 14, the mean reduction from baseline in Maximum Pain Intensity at Rest was greater in the celecoxib group compared with placebo (-35.0 +/- 3.06 mm vs -25.0 +/- 3.05 mm; p < 0.05). The mean reduction from baseline in Maximum Pain Intensity at Rest was also greater in the naproxen group compared with the placebo group at Day 7 (-26.4 +/- 2.70 mm vs -18.4 +/- 2.63 mm; p < 0.05), but not on Day 14. Secondary measures of efficacy also showed treatment with celecoxib to be significantly better than placebo treatment and similar to treatment with naproxen. In addition, celecoxib was well tolerated in these patients. CONCLUSION: Celecoxib showed comparable efficacy to naproxen in relieving the pain of patients with acute shoulder tendinitis and/or subacromial bursitis.