Randomized Clinical Trial
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Sep 20, 2024; 14(3): 93854
Published online Sep 20, 2024. doi: 10.5662/wjm.v14.i3.93854
Botulinum toxin type A for treating chronic low back pain: A double blinded randomized control study
Mantu Jain, Shahnawaz Khan, Paulson Varghese, Sujit Kumar Tripathy, Manaswini Mangaraj
Mantu Jain, Shahnawaz Khan, Paulson Varghese, Sujit Kumar Tripathy, Department of Orthopaedics, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India
Manaswini Mangaraj, Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India
Author contributions: Jain M, Tripathy SK and Mangaraj M conceived the idea; Jain M got the ethical clearance; Jain M, Varghese P, and Tripathy SK recruited the patients; Varghese P, Khan S, Jain M, and Tripathy SK followed up with them; Jain M, Khan S, and Mangaraj M prepared the initial draft of the manuscript, and the others (Tripathy SK and Varghese P) provided critical input; All authors read and agreed to the content of the paper for publication.
Supported by All India Institute of Medical Sciences Bhubaneswar Research Grant, No. AIIMS/BBSR/RS/2022/372.
Institutional review board statement: The Institutional review board approved the study, Institutional Ethical Committee Approval No. T/IM-F/21-22/03.
Clinical trial registration statement: This study has been registered in CTRI (https://ctri.nic.in/Clinicaltrials/login.php), No. CTRI/2022/08/044530.
Informed consent statement: Participation was contingent on patients providing written informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The data will be shared if needed at ortho_sujit@aiimsbhubaneswar.edu.in.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sujit Kumar Tripathy, MS, Professor, Department of Orthopaedics, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar 751019, Odisha, India. ortho_sujit@aiimsbhubaneswar.edu.in
Received: March 6, 2024
Revised: April 22, 2024
Accepted: May 11, 2024
Published online: September 20, 2024
Processing time: 110 Days and 17.3 Hours
Core Tip

Core Tip: This randomized clinical trial investigated Botulinum toxin type A (BoNT-A) for treating chronic low back pain (CLBP) in adults aged 18-60 years old with symptoms persisting for over six months. Participants were divided into two groups: one receiving BoNT-A and the other a placebo, with outcomes measured using the Visual Analog Scale for pain and the Oswestry Disability Index (ODI) for disability. After two months, both groups showed pain reduction, but only the decrease in ODI scores was statistically significant (but clinically insignificant). Ultimately, BoNT-A did not demonstrate a short-term advantage over placebo in reducing pain or improving disability scores in CLBP patients.