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Observational Study
©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Mar 20, 2026; 16(1): 107203
Published online Mar 20, 2026. doi: 10.5662/wjm.v16.i1.107203
Comparative effectiveness of amitriptyline vs duloxetine in the treatment of chronic low back pain: An observational study
Nityananda Sardar, Raktim Swarnakar, Soumyadipta Ghosh, Pankaj Kumar Mandal
Nityananda Sardar, Soumyadipta Ghosh, Pankaj Kumar Mandal, Physical Medicine and Rehabilitation, R. G. Kar Medical College and Hospital, Kolkata 700004, West Bengal, India
Raktim Swarnakar, Faculty of Physical Medicine and Rehabilitation, National Cancer Institute, Jhajjar Campus, All India Institute of Medical Sciences, New Delhi 110029, India
Author contributions: Sardar N, Swarnakar R, Ghosh S, and Mandal PK contributed to conception and design; Sardar N and Swarnakar R contributed to the literature search and writing; All authors read and approved the final version of the manuscript to be published.
Institutional review board statement: Ethics approval was obtained from the Institutional Ethical Committee of R.G. Kar Medical College and Hospital (No. RKC/687), Kolkata, West Bengal, India.
Informed consent statement: Written informed consent was obtained from all participants.
Conflict-of-interest statement: All authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement- checklist of items.
Data sharing statement: All the data regarding the article are available within the manuscript. However, if further data is needed, it will be made available from the corresponding author upon reasonable scientific request.
Corresponding author: Raktim Swarnakar, MD, Assistant Professor, Faculty of Physical Medicine and Rehabilitation, National Cancer Insitute, Jhajjar Campus, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. raktimswarnakar@hotmail.com
Received: March 19, 2025
Revised: May 15, 2025
Accepted: August 15, 2025
Published online: March 20, 2026
Processing time: 329 Days and 21.1 Hours
Abstract
BACKGROUND

Chronic nonspecific low back pain is defined as pain that persists for greater than 12 weeks and mainly occurs in the lower back with no evidence of associated underlying serious conditions [like malignancy, inflammation (like ankylosing spondylitis) or infection, vertebral fracture, etc.].

AIM

To compare the efficacy and safety of amitriptyline with duloxetine in treating chronic low back pain (CLBP).

METHODS

The present study was a two-arm observational study conducted over 18 months in a tertiary rehabilitation setting. A total of 254 patients were included in the study.

RESULTS

The mean age was significantly higher in the amitriptyline group (34.78 ± 8.22 years) compared with the duloxetine group (29.98 ± 7.28 years, P < 0.0001). Baseline visual analog scale (VAS) scores were also significantly different between groups (amitriptyline: 7.92 ± 0.56; duloxetine: 8.46 ± 0.79; P < 0.0001). Within-group analysis showed a significant reduction in VAS scores over time in both groups (P < 0.001). At 12 weeks the duloxetine group showed significantly lower VAS scores (0.92 ± 0.78) compared with the amitriptyline group (1.87 ± 1.71; P < 0.0001). Analysis of variance, adjusting for age and baseline VAS, confirmed a significant group effect on pain reduction at 12 weeks (P < 0.001), favoring duloxetine. Side effects were generally mild. The most common in the amitriptyline group were dry mouth (17.3%) and drowsiness (7.9%) while in the duloxetine group, dry mouth (15.7%) and constipation (2.4%) were most reported.

CONCLUSION

Amitriptyline and duloxetine effectively treat CLBP; however, considering side effects and more sustained pain relief, duloxetine appears to be the better option. Nonetheless, treatment choice should consider individual patient profiles.

Keywords: Amitriptyline; Duloxetine; Chronic low back pain; Neuropathic pain; Pain

Core Tip: This study compared the efficacy and safety of amitriptyline and duloxetine in treating chronic low back pain. Both medications were effective in reducing pain as evidenced by statistically significant improvements in the visual analog scale at 1 week, 4 weeks, and 12 weeks. However, duloxetine demonstrated a more favorable side effect profile and better long-term sustained effects with fewer anticholinergic and sedative effects compared with amitriptyline. These findings suggest that while both drugs are viable options for chronic low back pain management, duloxetine may be preferred for patients seeking a treatment with fewer side effects. The choice of medication should be individualized based on patient-specific factors and health conditions.