Prospective, open-label, randomized, parallel group, comparative clinical study of two topical formulations of diclofenac diethylamine in the treatment of acute painful musculoskeletal conditions

Abstract

Background: Oral nonsteroidal anti-inflammatory drugs have been used in the management of musculoskeletal pain due to inconsistent skin penetration of topical formulations. The quick penetrating solution of diclofenac is a novel topical solution of diclofenac diethylamine (4.64%), which has increased skin penetration. The present study was designed to compare the efficacy and safety of quick penetrating solution of diclofenac with diclofenac gel in patients with acute musculoskeletal pain. Materials and Methods: A randomized controlled clinical trial was conducted in 140 patients suffering from acute musculoskeletal pain who were randomized to receive diclofenac diethylamine 4.64% w/v topical solution (Group A) or diclofenac diethylamine 1.16% gel (Group B). The pain intensity difference (PID) between patients in both groups at rest and during movement of the affected area on day 3 and day 7 after injury was noted using the visual analog scale (VAS) and were compared with the baseline. A comparison of the requirement of oral rescue analgesics and adverse effects in both groups was also carried out. Results: The PID in VAS from baseline was significantly better in patients in Group A than patients in Group B on days 3 (3.74 and 2.42;P