Copyright
©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
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).
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
BACKGROUND
Lumbar disc herniation and non-specific low back pain are common conditions that seriously affect patients’ health-related quality of life (HRQoL). Although empirical evidence has demonstrated that novel Thermobalancing therapy and Dr Allen’s Device can relieve chronic low back pain, there have been no randomised controlled trials for these indications.
AIM
To evaluate the efficacy of Dr Allen’s Device in lumbar disc herniation (LDH) and non-specific low back pain (NSLBP).
METHODS
A randomised clinical trial was conducted investigating 55 patients with chronic low back pain due to LDH (n = 28) or NSLBP (n = 27), out of which 15 were randomly assigned to the control group and 40 were assigned to the treatment group. The intervention was treatment with Dr Allen’s Device for 3 mo. Changes in HRQoL were assessed using the Numerical Pain Rating Scale and the Japanese Orthopedic Association Back Pain Questionnaire.
RESULTS
Thermobalancing therapy with Dr Allen’s Device showed a significant reduction in pain in the treatment group (P < 0.001), with no recorded adverse effects. Both pain assessment scales showed a significant improvement in patients’ perception of pain indicating improvement in HRQoL.
CONCLUSION
The out-of-hospital use of Thermobalancing therapy with Dr Allen’s Device for Low Back Treatment relieves chronic low back pain significantly and without adverse effects, improves the level of activity and HRQoL among patients with LDH and NSLBP. This study demonstrates the importance of this safe first-line therapy that can be used for effective at-home management of chronic low back pain.
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.
