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

BACKGROUND: More than 80% of the population suffer from low back pain at some time during their lives. An orthopedic device (LSM-01) will be used to alleviate back pain caused by muscle tension. LSM-01, which has a rotating roller, stimulates meridian-muscles around the governor vessel, bladder meridian, and gall bladder meridian. METHODS: This study will be a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Subjects will be randomly allocated to the treatment group (LSM-01) or the control group (sham device). The duration of the clinical trial will be 2 weeks. The primary outcomes will be measured using the visual analog scale; the secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and Patient Global Impression of Change. Statistical analysis will be performed for the full study population. Analysis of covariance will be conducted to identify differences in pain before and after the application of the device. DISCUSSION: This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this investigation includes a limited number of subjects. The results of this pilot trial will form a basis for a large-scale clinical trial, which will be conducted in the future. CLINICAL TRIAL REGISTRATION: This study protocol is registered with the Clinical Research Information Service (CRIS) of Korea. Clinical trial registration number: CRIS-KCT0006425. Registered: October 5, 2021; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=L&pageSize=10&page=undefined&seq=20056&status=5&seq_group=20056