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

This is a Prospective,randomized, clinical trial to compare efficacy of two topical formulations of Diclofenac Diethylamine in the Treatment of Acute Painful Musculoskeletal Conditions being carried out in a tertiary care centre of Pune. Patients with acute musculo-skeletal pain (total of 140) are being randomise in to two groups and given the two above mentioned formulations. The primary and secondary objectives mentioned before are assessed using VAS and other scales as mentioned in the methodology. The measurements of the same are being carried out on Day 3 and 7 of the intervention.Results will be tabulated,statistically analysed and forwarded.

Results:

Both the topical formulations of diclofenac were found to be effective and safe in management in acute painful musculoskeletal conditions when compared with baseline assessment. However, topical solution of diclofenac 4.64% w/v was superior to diclofenac topical gel 1.16% w/w in the both primary and secondary efficacy endpoints. The pain intensity difference was significantly lesser with Diclofenac topical 4.64% topical solution as compared to diclofenac topical gel 1.16% w/w on day 3 (P < 0.05) and day 7 (P < 0.05). Further, it was observed that, there was more proportion of groups B patients (22.85%) who required rescue analgesia when treated with topical diclofenac gel as compared to group A patients (1.42%) treated with Diclofenac topical 4.64% topical solution.