Thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain due to lumbar disc herniation or non-specific low back pain

To determine the effectiveness of thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain (CLBP) due to lumbar disc herniation or non-specific low back pain

Two arm parallel design randomized controlled trial.

The study will be conducted at Physical Therapy clinic of Government College University Faisalabad. Potential participants visiting clinic who fulfil edibility criteria will be provided with participant information sheet and if agree to participate, informed consent will be obtained. After baseline assessment participants will be randomized.

Inclusion criteria: Subjects with chronic low back pain, age ≥18 years ≤ 70 years. Subjects should be diagnosed with lumbar disc herniation or nonspecific low back pain. Exclusion criteria: patients with lumbar spinal stenosis, lumbar spondylolisthesis, lumbar scoliosis, or a history of lumbar spine surgery. Also, should be excluded people with severe comorbidities including cancer, heart failure and chronic infectious diseases.

Participants in the treatment group will receive thermobalancing with Dr Allen’s Device for 3 months. Dr Allen’s Device consist of a soft belt, which contains thermoelement(s) from the special mixture of natural waxes, is used. Participants will be guided to wear the belt for maximum time throughout the daytime. Patients in the control group will be placed in watchful waiting list and will not receive any active treatment.

Pain (Numerical Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire) and low back pain symptoms (The Japanese Orthopedic Association Back Pain Evaluation Questionnaire) will be assessed at baseline, after 1 and 3 months after the treatment.

The trial is completed

After completion of baseline Case report form, the participants (individuals) will be randomized to either the treatment or control group. Through simple randomization methods, participants will be randomized based on 1:1 allocation ratio. The randomization will be performed online based on a computer-generated randomization sequence using Openepi (www.openepi.com). The random sequence obtained from Openepi software will be stored with the trial data manager. After recruitment of the participant, research assistant will inform trial data manager to generate a randomization link from the software for the participant. After generating randomization link by the trial data manager, a research assistant will open the randomization link which will show the assigned group for the participants. The participant will be allocated to either treatment group or control group accordingly. The allocation will not be concealed as trail data manager, research assistant and participant will be aware of the allocation.

The findiings of the trial will be published in a research jounral and all the documents will be attached as supplementary files.

The data will be available right after the publication.

The data/ documents will be available only for academicians/ researchers and clinicians.

The data/ documents can be used only for academic purposes.

From research journal website where the article will be published.

No specific processes will be involved as relevant documents/data will be available as supplementary files with published article.

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. Allen S, Rashid A, Adjani A, Akram M, Khan FS, Sherwani R, Khalil MT. Efficacy and safety of thermobalancing therapy with Dr Allen’s Device for chronic low back pain: A randomised controlled trial. World J Orthop 2023; 14(12): 878-888 [PMID: 38173805 DOI: 10.5312/wjo.v14.i12.878]