Tizanidine and
aceclofenac individually have shown efficacy in the treatment of
low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of
aceclofenac-
tizanidine fixed dose combination against
aceclofenac alone in patients with acute
low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18-70 years with acute
low back pain. The patients were randomized to receive either
aceclofenac (100 mg)-tizanidine (2 mg) b.i.d or
aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were
pain intensity (on movement, at rest and at night; on VAS scale) and
pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober's test and lateral body bending test) and patient's and investigator's global efficacy assessment.
aceclofenac-
tizanidine was significantly superior to
aceclofenac for
pain intensity (on movement, at rest and at night; P < 0.05) and
pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the
aceclofenac-
tizanidine treatment as compared to
aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study,
aceclofenac-
tizanidine combination was more effective than
aceclofenac alone and had a favourable safety profile in the treatment of acute
low back pain.