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IRCT20211022052833N2 IRCT 2023-04-09 Fine Treatment Thermobalancing therapy for low back pain 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 2023-04-10 anticipated 54 Complete https://irct.ir/trial/69235 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. N/A Chronic low back pain due to lumbar disc herniation or nonspecific low back pain. Intervention 1: Intervention group: 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 (for at least 8 hours a day) throughout the daytime. A physical therapist will guide the participants how to wear the belt and how to remove it. Participants will be guided to note the number of days, on which they are not wearing the belt due to any reason. Participants will use diary to report the use and non-use of the belt. Intervention 2: Control group: Patients in the control group will be placed in watchful waiting list and will not receive any active treatment. https://www.wjgnet.com/2218-5836/full/v14/i12/878.htm 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] Yes - There is a plan to make this available What will be shared: The findiings of the trial will be published in a research jounral and all the documents will be attached as supplementary files. When: The data will be available right after the publication. To whom: The data/ documents will be available only for academicians/ researchers and clinicians. Conditions: The data/ documents can be used only for academic purposes. Where to obtain: From research journal website where the article will be published. How to obtain: No specific processes will be involved as relevant documents/data will be available as supplementary files with published article. Comments:
public Muhammad Akram
Chenab chowk , jhang road opposite Mr Winggs Faisalabad, Faisalabad, Punjab,38000
Faisalabad Pakistan 38000 +92 41 9200670 makram_0451@yahoo.com Government College University Faisalabad Pakistan scientific Muhammad Akram
Chenab chowk , jhang road opposite Mr Winggs Faisalabad, Faisalabad, Punjab,38000
Faisalabad Pakistan 38000 +92 41 9200670 makram_0451@yahoo.com Government College University Faisalabad Pakistan Pakistan Subjects, age greater than 18 years and less than 70 years with chronic low back pain Subjects with diagnosis of lumbar disc herniation or nonspecific low back pain 18 years 70 years Both Subjects with lumbar spinal stenosis, lumbar spondylolisthesis, lumbar scoliosis, or a history of lumbar spine surgery Subjects with severe comorbidities including cancer, heart failure and chronic infectious diseases M54.56 Low back pain, lumbar region Treatment - Devices N/A Intervention group: 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 (for at least 8 hours a day) throughout the daytime. A physical therapist will guide the participants how to wear the belt and how to remove it. Participants will be guided to note the number of days, on which they are not wearing the belt due to any reason. Participants will use diary to report the use and non-use of the belt. Control group: Patients in the control group will be placed in watchful waiting list and will not receive any active treatment. Pain. Timepoint: Before intervention and 1, 3 months after intervention. Method of measurement: Numerical Pain Rating Scale. Disability. Timepoint: Before intervention and 1, 3 months after intervention. Method of measurement: Roland Morris Disability Questionnaire. Low back pain symptoms. Timepoint: Before intervention and 1, 3 months after intervention. Method of measurement: The Japanese Orthopedic Association Back Pain Evaluation Questionnaire. Fine Treatment Approved 2021-10-03 Ethics Review Committee of the Government College University Faisalabad Chenab chowk , jhang road opposite Mr Winggs Faisalabad, Faisalabad, Punjab,38000 Faisalabad Punjab Pakistan