A randomized, patient-blinded, placebo-controlled, prospective multi-center confirmative clinical trial to evaluate the safety and short-term efficacy of 650nm wavelength invasive laser medical device (Ellise) on non specific chronic low back pain

WONTECH0 个研究点目标入组 106 人开始时间: 待定最近更新: 2023年11月13日

适应症

试验速览

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•Participants who meet all of the following criteria will be included in this trial:
•1) aged between 19 and 70 years
•2) has NSCLBP lasting for at least the preceding three months and has occurred on at least 14 days of each of the preceding 3 months
•3) has no change in history of medications for 4 weeks before screening. For participants with medications prescribed and used for NSCLBP, usage shall be at a stable dose in the 4 weeks prior to the screening visit
•4) has moderate pain ( 100mm VAS scores for pain was 35-74) at the time of screening
•5) has adequate level of Korean language proficiency for the reliable completion of all study assessments
•6) voluntarily provides informed consent.

•The exclusion criteria are as follows:
•1) radicular pain or progressive neurological deficits
•2) diagnosis of a serious spinal pathology (cancer, recent vertebral fracture, spinal infection, inflammatory spondylitis, or cauda equina syndrome)
•3) presence of a serious chronic disease (cancer, severe cardiovascular, cerebrovascular, liver, kidney disease, or diabetic neuropathy)
•4) history of treatment for alcohol/drug dependency or mental illness (schizophrenia, dementia, epilepsy, or depression) in the 6 months preceding enrollment
•5) LBP caused by trauma, ankylosing spondylitis, fibromyalgia, rheumatoid arthritis, or gout
•6) presence of contradictions for LA , such as blood clotting abnormalities (hemophilia), severe skin disease in the lumbar region, presence of metallic devices in the lumbar spine, or presence of electronic medical devices (pacemaker)
•7) moderate or severe depression (scored = 23 points on a Korean version of Beck depression inventory-? ) at the time of screening
•8) previous lumbar spinal surgery within a year or scheduled procedures during the study
•9) pregnancy or planning to become pregnant
•10) concurrent participation in other clinical trials
•11) for the purpose of social insurance or compensation
•12) not suitable for ILA and our rescue regimen

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