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
Abstract
BACKGROUND

Low back pain (LBP) is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting. LBP can arise from various causes, with stiffness in the paraspinal muscles being a notable contributor. The administration of Botulinum toxin type A (BoNT-A) has been found to alleviate back pain by relaxing these stiff muscles. While BoNT-A is approved for use in numerous conditions, a limited number of randomized clinical trials (RCTs) validate its efficacy specifically for treating LBP.

AIM

To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP (CLBP).

METHODS

In this RCT, adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled. Participants were allocated to either the Drug group, receiving 200 Ipsen Units (2 mL) of BoNT-A, or the Control group, which received a 2 mL placebo. Over a 2-month follow-up period, both groups were assessed using the Visual Analog Scale (VAS) for pain intensity and the Oswestry Disability Index (ODI) for disability at the start and conclusion of the study. A decrease in pain by 50% was deemed clinically significant.

RESULTS

The study followed 40 patients for two months, with 20 in each group. A clinically significant reduction in pain was observed in 36 participants. There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months. Nonetheless, when comparing the mean score changes, only the reduction in ODI scores (15 in the placebo group vs 16.5 in the drug group, clinically insignificant) was statistically significant (P = 0.012), whereas the change in mean VAS scores was not significant (P = 0.45).

CONCLUSION

The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients.

Keywords: Botulinum toxin type A; Chronic low back pain; Randomized control study; Double-blinded; Pain management; Therapeutic efficacy

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.