Efficacy and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial

Background: Low back pain refers to pain that occurs mainly in lumbosacral spine, and is a clinically common symptom that 70% to 90% of people experience at least once during their lives. Objectives: We investigated the effect and safety of orthopedic device (LSM-01) for alleviate back pain caused by muscle tension in a randomized, single-blinded, sham-controlled, parallel-group, pilot trial to establish a basis for large-scale clinical trial. Methods: A total of 30 subjects were randomly assigned to 2 group: treatment group (LSM-01) and control group (sham device) received treatment with each device 2 to 3 times a week for a total of 6 treatment for 2 weeks. Primary outcome was visual analog scale (VAS); Secondary outcomes were pressure pain threshold (PPT), oswestry disability index (ODI), and patient global impression of change (PGIC). Statistical analysis is performed for full analysis set (FAS) population. Analysis of covariance (ANCOVA) for mean difference of VAS change and Mixed models of repeated measurements (MMRM) for the trend of VAS change were conducted to compare the differences between 2 groups before and after participants got treatment with the clinical trial device. Results: One participant dropped out due to personal reason and 29 participants completed the clinical pilot trial. We found that the degree of low back pain (VAS, PPT, PGIC) significantly decreased and after the trial in the treatment group compared to the control group. Also, there were no any side effects. Conclusion: LSM-01 can be effective in improving pain of low back pain. A future large-scale main trial will be conducted based on this pilot study results.