Automated Thermo-mechanical Therapy for Immediate Relief in Chronic Non-Specific Lower Back Pain (cNSLBP): A Randomized Controlled Trial

Kyle Donnery^1*Giuseppina Pilloni²Mohamad FallahRad¹Kiwon Lee³Byungyun Han³Soonhi Park³Jihye Kim³Leigh Charvet²Marom Bikson¹

• ¹Department of Biomedical Engineering, The City College of New York, New York, United States
• ²Department of Neurology, NYU Grossman School of Medicine, New York, United States
• ³Clinical Research Institute, Ceragem Clinical Inc, Gyeonggi-do, Republic of Korea

Objective: Chronic non-specific lower back pain (cNSLBP) is a prevalent and disabling condition, imposing a substantial socioeconomic burden due to high healthcare costs and productivity losses, with limited accessible and effective long-term treatment options. Automated Thermo-mechanical Therapy (ATT) is a promising, non-drug intervention that leverages innovative technical advances to provide multimodal pain relief, offering accessibility and low-cost delivery. This study tested ATT for immediate pain relief in individuals with cNSLBP in a single-session, double-blind, randomized controlled trial. Methods: Forty participants with cNSLBP were assigned to receive either active ATT (n=20) or control ATT (n=20) in a 40-minute session with urn randomization. The active device applied heated cylindrical rollers along the spine, using far-infrared heat and mechanical tissue stimulation tailored to spinal alignment. In the control condition, the device used minimal mechanical therapy intensity without heat, targeting only the cervical area to avoid lower back therapeutic effects. Pre-and post-intervention assessments measured changes in pain intensity (primary outcome) via a 100-mm Visual Analogue Scale for Pain (VAS-P100), alongside secondary outcomes assessing pain characteristics, anxiety, and functional mobility. Results: The active ATT group showed a significant reduction in pain on the VAS-P100, with an average decrease of 46.8%, compared to 17.0% in the control group. Participants in the active group also reported significantly greater subjective pain relief (p = 7.88e-05). Secondary outcomes demonstrated significant improvements in lumbar flexibility (Modified-Modified Schober Test, MMST) for the active ATT group compared to the control group (p = 0.0031). No adverse events were reported, and all participants tolerated the intervention well. Conclusions: A single session of ATT provides immediate, significant pain relief in individuals with cNSLBP, supporting its potential as a safe, non-invasive option for managing chronic back pain. Future studies should examine the long-term benefits of repeated ATT sessions and explore mechanistic insights into thermo-mechanical stimulation's effects on pain and function.