Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone
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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.
KeywordsAceclofenac-tizanidine Acute LBP Aceclofenac
This study has been sponsored by Ipca Laboratories Limited. The authors would like to thank Ms. Smita Talekar, for her technical assistance right from the inception of the study, and Mr. Mitesh Sharma, biostatistician for statistical analysis and data management for this study. Dr. Anil Pareek and Nitin Chandurkar, who are employees of Ipca Laboratories Limited, were involved in the conceptualization, coordination and execution of the study at all the centres. The experiment complies with the current laws of the country in which they were performed inclusive of the ethics approval.
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