A randomized, outcome assessor-blinded, placebo-controlled, single center pilot clinical trial to evaluate the safety and different efficacy of different wavelength of invasive laser medical device combined with electrical stimulator(Ellise) on chronic non speicific low back pain

WONTECH0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年1月28日

适应症

试验速览

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•Participants meeting all of the following criteria will be included in this trial:1) male or female aged 19 to 70 years; 2) experiencing CLBP lasting for at least the previous three months; 3) Scoring = 40 points on a 100-mm VAS for pain at the time of screening; 4) Korean language fluency that is adequate for reliable completion of all study assessments; and 5) voluntary provision of informed consent.

•The exclusion criteria are as follows: 1) Radicular pain or progressive neurological deficit; 2) diagnosis of serious spinal pathology(e.g., cancer, recent vertebral fracture, spinal infection, and inflammatory spondylitis); 3) presence of serious chronic disease (e.g., cancer, severe cardiovascular, cerebrovascular, liver, kidney disease, or diabetic neuropathy); 4) history of treatment for alcohol/drug dependency or mental diseases(e.g., schizophrenia, demetia, or epilepsy) in the six months preceding enrollment; 5) LBP is not caused by spinal or soft tissue diseases(e.g., trauma, ankylosing spondylitis, fibromyalgia, rheumatoid arthritis, or gout); 6) presence of contradictions for LA or EA, such as blood clotting abnormalities(e.g., hemophilia), severe skin disease in the lumbar region, presence of metalic device in the lumbar spine, or attaching of electronic medical device(e.g.,pacemaker); 7) Previous lumbar spinal surgery within a year or scheduled procedures during the study; 8) pregnancy or planning to become pregnant; and 9) concurrent participation in other clinical trials.

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