Double-Blind, Randomized Crossover Study of the Percutaneous Efficacy and Tolerability of a Topical Indomethacin Spray versus Placebo in the Treatment of Tendinitis

Abstract

Percutaneous efficacy and tolerability of a new topical indomethacin spray compared with a corresponding placebo product were evaluated in a double-blind, randomized crossover study in 30 patients with tendinitis, i.e. 28 patients with peri-arthritis of the shoulder and two with epicondylitis. Each patient was treated with 4% indomethacin spray or the corresponding placebo product three to five times daily for a period of 14 days and then received the other treatment for the same period of time. The indomethacin spray demonstrated a clear efficacy compared with the placebo based on both objective criteria (elevation, abduction and internal rotation) and subjective criteria (spontaneous pain, pain on movement, pressure-induced pain, functional disturbances and sleep disturbances). Tolerability was excellent: only two patients had minor local cutaneous irritation with the indomethacin spray, which did not require interruption of treatment. Treatment with indomethacin spray appeared to be effective in 80% and well-tolerated in 93% of the patients studied.