Evaluation of the Efficacy and Safety of an Orthopedic Appliance (LSM-01) for Low Back Pain: A Randomized, Single-Blind, Simulation-Controlled, Parallel-Group Pilot Clinical Trial

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Medicine (Baltimore). 2022 Jan 21;101(3):e28527. doi: 10.1097/MD.0000000000028527.


BACKGROUND: Over 80% of the population suffers from low back pain at some point in their lives. A brace (LSM-01) will be used to relieve back pain caused by muscle tension. The LSM-01, which has a rotating roller, stimulates the meridian muscles around the governor vessel, the bladder meridian and the gallbladder meridian.

METHODS: This study will be a pilot randomized, single-blind, simulation-controlled, parallel-group clinical trial. Subjects will be randomly assigned to the treatment group (LSM-01) or control group (dummy device). The duration of the clinical trial will be 2 weeks. The main results will be measured using the visual analogue scale; secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and patient’s global impression of change. The statistical analysis will be carried out for the entire population studied. An analysis of covariance will be performed to identify differences in pain before and after application of the device.

DISCUSSION: This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this survey includes a limited number of subjects. The results of this pilot trial will form the basis of 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. Listed: 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.

PMID:35060507 | DOI:10.1097/MD.0000000000028527

Sara H. Byrd