Abstract:
Background Chronic non-specific low back pain (CNLBP) is a highly prevalent musculoskeletal disorder in clinical practice, characterized by a long disease course and complex pathological mechanisms. Graphene-based flexible heating materials, with their unique advantages, have provided a new approach for the non-invasive rehabilitation treatment of CNLBP. Objective To preliminarily evaluate the clinical efficacy of the graphene heating waist belt in the treatment of CNLBP. Methods This prospective self-controlled study enrolled consecutive CNLBP patients presenting to our institution from May 2024 to January 2025. All participants underwent a 2-week physiotherapeutic intervention with the graphene intelligent heating waist belt. Relevant indicators, including pain intensity, lumbar function, psychological status, quality of life, and muscular biomechanical parameters, were evaluated at baseline and at 1 and 2 weeks after treatment initiation. A repeated measures analysis of variance (ANOVA) was used to compare the differences in indicators across the various time points, including the Visual Analogue Scale (VAS), Short-Form McGill Pain Questionnaire (SF-MPQ), Range of Motion (ROM), Oswestry Disability Index (ODI), Japanese Orthopaedic Association Scores for Lumbar Spine (JOA), Fear-Avoidance Beliefs Questionnaire (FABQ), Central Sensitization Inventory (CSI), 36-Item Short Form Survey (SF-36), muscle tension, and Young's modulus. Results A total of 31 patients were enrolled, consisting of 28 males and 3 females, with a mean age of (28.16±3.93) years and a mean disease duration of 2.29 years. After 1 week of treatment, VAS scores (both during movement and at rest), SF-MPQ scores, ODI scores, and the contraction displacement and contraction area under the curve (AUC) of the erector spinae muscle decreased significantly (P<0.05), while lumbar ROM, JOA scores, and the area difference between contraction and relaxation of the erector spinae muscle increased significantly (P<0.05). After 2 weeks of treatment, except for muscle tone indices, the aforementioned measures showed further significant improvements consistent with the initial trend, and FABQ and CSI scores showed significant improvements for the first time (P<0.05). However, no significant changes were observed in SF-36 scores, erector spinae muscle relaxation displacement, relaxation AUC, or Young's modulus throughout the treatment period (P>0.05). Conclusion The graphene heating waist belt plays a positive role in pain relief, lumbar function improvement, and psychological status adjustment for patients with CNLBP, while its short-term effects on improving quality of life and modifying muscular biomechanical characteristics are limited. Further large-scale and rigorously designed clinical trials are required to verify these findings.