Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system) in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

摘要

BackgroundLow back pain (LBP) is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH^® system (system for automatic thermomechanic massage in health) is a new medical device (MD) that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH^® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP.