An Open-Label, Randomized, Parallel-Group Study to Assess the Safety, Efficacy, and Tolerability of Tapentadol Versus Tramadol in Outpatients with Moderate to Severe Chronic Low Back Pain at a Tertiary Care Hospital in South India

S Naveen¹, P Elango² and Ramya S^3*

¹Pharmacology Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research (SRIHER) Chennai, India.

²Department of Pharmacology, Bharath Medical College and Hospital (BMCH), Bhaarath Institute of Higher Education and Research (BIHER, Bhaarath University) Chennai, India.

³Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research (SRIHER) Chennai, India.

Corresponding Author E-mail: ramya.s@sriramachandra.edu.in

Abstract: Background: Low back pain is a very common musculoskeletal symptom with multifactorial aetiology. Aims and objectives: Our study aimed at comparing the efficacy, safety, and tolerability of tapentadol versus tramadol in out-patients with moderate to severe chronic low back pain. Methodology: Fifty-two patients with a diagnosis of chronic low back pain for > 3 months were randomly assigned to receive either a 50 mg tablet of tapentadol (twice daily) or 50 mg tablet of tramadol (twice daily) for 1 week. The mean (±SD) difference in the reduction of pain (at end of 1 week) between the two groups was compared employing an independent student t-test for difference in mean values separately for the Visual Analogue Scale (VAS) and Roland Morris Disability Questionnaire (RMDQ) scores. The frequency of the different adverse events between the two groups was compared employing Chi-square test. Results: Except for VAS scores, the baseline demographic parameters of the two groups were comparable. The study found that tapentadol reduced VAS and RMDQ scores more than tramadol (statistically significant p<0.001) between baseline and the end of week 1. Regarding safety and tolerability, the tapentadol group experienced nausea/vomiting and dizziness/somnolence more frequently than the tramadol group, with p-values of 0.011 and 0.001 respectively. Both groups experienced similar rates of headache and constipation, with p-values of 0.668 and 0.610, respectively. Conclusion: When compared to tramadol (50 mg twice daily), tapentadol (50mg twice daily) was found to significantly improve pain and disability in patients with moderate to severe chronic low back pain, while tapentadol had greater frequencies of side effects like nausea, vomiting, dizziness, and somnolence.

Keywords: Efficacy; Low Back Pain; Safety; Tramadol; Tapentadol

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