Evaluation of analgesic effect of tapentadol, a central novel analgesic versus tramadol, a widely used opioid analgesic in treatment of low back pain: a randomized controlled trial.

ABSTRACT

Background: The objective of the study was to compare efficacy and tolerability (safety) of tapentadol with tramadol in the treatment of low back pain. Methods: The study was a prospective, randomized, single blinded, total 102 patients are recruited for study in which 44 patients are prescribed (50mgtwice daily) tapentadol and 58 patients prescribed (50mg twice daily) tramadol for 4 weeks. Follow-up was done on days 7, 14, 28 and 4 week after stoppage of treatment. Assessment of improvement were performed by Indian Health Assessment Questionnaire Disability Index (Indian HAQDI), Visual Analogue Scale (VAS), Numerical Rating Scale (NRS) and measurement of Pain Relief Rate (PRR). Adverse events were recorded. Results: Scores in Indian HAQDI, VAS and NRS improved significantly in both groups in the last visit but more so with tapentadol. PRR was reasonably higher with tapentadol [27(n=44)61.36%] patients experiencing significant to complete pain relief at the end of the study, compared to tramadol [25(n=58) 43.10%]. Adverse effects was less in tapentadol group [15(n=44)34.09%] versus 33(n=58)56.89%], p<0.05]. Conclusion: Tapentadol has better sustained efficacy and tolerability than tramadol in low back pain.