An open labeled randomized controlled trial of pregabalin versus amitriptyline in chronic low backache.

BACKGROUND: There is no head on comparison of amitriptyline (AMT) and pregabalin (PG) in relieving pain and disability in chronic low backache (CLBA). This randomized controlled trial reports the efficacy and safety of AMT and PG in CLBA.

METHODS: Patients with CLBA, 15-65 years of age without specific cause and significant neurological deficit were included. Severity of pain was assessed by Visual Analogue Scale (VAS) and disability by Oswestry Disability Index (ODI). Patients were followed up at 6 and 14 weeks and their VAS score, ODI and side effect were noted. Primary outcome was pain relief (>50% improvement in VAS score) at 14 weeks and secondary outcome were reduction in ODI (>20%) and side effects.

RESULTS: 200 patients with CLBA were randomized to AMT (n=103) and PG (n=97) using random numbers. The VAS score and ODI improved significantly following AMT and PG at 6 and 14 weeks compared to baseline. The improvement in pain (57.3% Vs 39.2%; P=0.01) and disability (65% Vs 49.5%; P=0.03) however was more in AMT group. The composite side effects were similar in both groups.

CONCLUSION: AMT and PG are effective in CLBA but AMT reduced pain and disability significantly compared to PG.