Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Dec 18, 2023; 14(12): 878-888
Published online Dec 18, 2023. doi: 10.5312/wjo.v14.i12.878
Efficacy and safety of thermobalancing therapy with Dr Allen’s Device for chronic low back pain: A randomised controlled trial
Simon Allen, Abid Rashid, Ariana Adjani, Muhammad Akram, Fahad Said Khan, Rehan Sherwani, Muhammad Talha Khalil
Simon Allen, Director and Head of Medical Research, Fine Treatment, Oxford OX2 7SL, United Kingdom
Abid Rashid, Director of Faculty of Medical Sciences, Government College University Faisalabad, Faisalabad 38000, Pakistan
Ariana Adjani, Senior Researcher, Fine Treatment, Oxford OX2 7SL, United Kingdom
Muhammad Akram, Muhammad Talha Khalil, Department of Eastern Medicine, Government College University Faisalabad, Faisalabad 38000, Pakistan
Fahad Said Khan, Faculty of Medical and Health Sciences, University of Poonch Rawalakot, Rawalakot 12350, Pakistan
Rehan Sherwani, College of Statistical and Actuarial Science, University of the Punjab, Lahore 54000, Pakistan
Author contributions: Allen S, Rashid A, Adjani A and Akram M designed the research study; Akram M, Khan FS and Khalil MT performed the research; Sherwani R contributed as statistician; Allen S, Rashid A, Adjani A and Akram M analysed the data and wrote the manuscript; All authors have read and approved the final manuscript.
Institutional review board statement: This study was performed in line with the principles of the Declaration of Helsinki. The study was reviewed and approved by the Ethics Review Committee of the Government College University Faisalabad (Approval No. GCUF/ERC/111).
Clinical trial registration statement: This study is registered at https://www.irct.ir/trial/69235. The IRCT registration number is: IRCT20211022052833N2.
Informed consent statement: All study participants provided informed written consent prior to study enrolment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The datasets used and/or analysed during the current study and the full trial protocol are available from the corresponding author upon reasonable request.
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: Simon Allen, MD, PhD, Director and Head of Medical Research, Fine Treatment, 14 Drew House, Islip Road, Oxford OX2 7SL, United Kingdom. info@finetreatment.com
Received: June 20, 2023
Peer-review started: June 20, 2023
First decision: August 30, 2023
Revised: September 12, 2023
Accepted: November 8, 2023
Article in press: November 8, 2023
Published online: December 18, 2023
Processing time: 177 Days and 18.2 Hours
Core Tip

Core Tip: This prospective randomised controlled trial assessed the efficacy and safety of novel Thermobalancing therapy and wearable Dr Allen’s Device for chronic low back pain. Patients with non-specific low back pain and lumbar disc herniation were assessed by the Numerical Pain Rating Scale, and the Japanese Orthopedic Association Back Pain Evaluation Questionnaire. Research results showed a significant reduction in pain and the improvement in patients’ health-related quality of life in the treatment group. No adverse effects were observed. Therefore, Thermobalancing therapy with Dr Allen’s Device can be recommended for the at-home management of chronic low back pain.