A multiple centre study to check the efficacy and safety of Topical formulation of Diclofenac plus Thiocolchicoside in comparison with Diclofenac Gel in acute low back pain.
This study was a randomised, two arm, open label, active controlled, multicentric clinical study to evaluate the safety and efficacy of a topical fixed dose combination of a muscle relaxant Thiocolchicoside and a non steroidal anti-inflammatory drug, Diclofenac in comparison with Diclofenac topical Gel (1.16 w/w) in acute non specific low back pain in total of 150 patients at multiple sites in India. Patients were randomised to receive either Diclofenac plus Thiocolchicoside topical solution or topical Diclofenac Gel. The primary outcome was pain relief with study medication, to be assessed on Day 3 . The secondary outcome was pain relief on Day 7, pain relief scores for the entire treatment period, Rolland Moris Disability score along with patients & physicians global assessment on Day 7.
Pain relief on Day 3 and Day 7 of treatment was significantly higher in Diclofenac + Thiocolchicoside group as compared to the Diclofenac Gel group. Pain relief score for the entire treatment period and Roland and Morris Disability scoring were significantly higher in the Diclofenac + Thiocolchicoside group as compared to Diclofenac Gel group. Both physicians and patients global assessment were favorable towards Diclofenac + Thiocolchicoside group as compared to Diclofenac Gel group.
Thus it can be concluded that Topical solution of Diclofenac + Thiocolchicoside is more effective as compared to Diclofenac Topical Gel in the management of acute nonspecific low back pain. No adverse event was reported among both the treatment groups and both the treatment were found safe.
Pain relief on Day 3 and Day 7 of treatment was significantly higher in Diclofenac + Thiocolchicoside group as compared to the Diclofenac Gel group. Pain relief score for the entire treatment period and Roland and Morris Disability scoring were significantly higher in the Diclofenac + Thiocolchicoside group as compared to Diclofenac Gel group. Both physicians and patients global assessment were favorable towards Diclofenac + Thiocolchicoside group as compared to Diclofenac Gel group.
Thus it can be concluded that Topical solution of Diclofenac + Thiocolchicoside is more effective as compared to Diclofenac Topical Gel in the management of acute nonspecific low back pain. No adverse event was reported among both the treatment groups and both the treatment were found safe.
