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
ARTICLE HIGHLIGHTS
Research background

Chronic low back pain (CLBP) is a highly prevalent cause of disability worldwide. Of the numerous causes of low back pain, lumbar disc herniation (LDH) is a major contributor accounting for around 9% of CLBP in the population. The main symptom of LDH is chronic pain in the lower spine area that can impact the quality of life and heavily burden individuals, their families, and society. Standard treatments include pain management with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and anticonvulsants, steroid injections, and spinal surgeries.

Research motivation

Multiple adverse effects of the standard treatment options for low back pain limit their use and highlight the pressing need for a new conservative, safe and effective mode of treatment.

Research objectives

This is the first clinical study that attempts to demonstrate the efficacy and safety of Dr Allen’s Device for Low Back Pain Treatment in patients with chronic low back pain due to lumbar disc herniation (LDH) or non-specific low back pain (NSLBP), as well as the ability of this therapy to improve health-related quality of life.

Research methods

A total of 55 patients with chronic low back pain were recruited and randomised for the clinical trial. Thermobalancing therapy with Dr Allen’s Device for Low Back Pain Treatment was used as a monotherapy for a 3-month period. The Numerical Pain Rating Scale (NPRS) and the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) were used to assess the effectiveness of treatment. The effect on chronic low back pain was assessed as the primary health outcome.

Research results

The study showed that most patients in the treatment group experienced a significant pain reduction in the low back area, an improvement in the lumbar function, walking ability, social life, and mental health, with no patients showing worsening of these parameters. It was confirmed that the treatment with Dr Allen’s Device was effective and safe in patients with non-specific low back pain and lumbar disc herniation.

Research conclusions

Thermobalancing therapy with Dr Allen’s Device can be recommended for an effective at-home management of chronic low back pain.

Research perspectives

The results suggest that this treatment may also be effective and safe for other types of chronic back pain and further research in this direction is needed.