KCT0007167
Completed
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Sponsor
- WONTECH
- Enrollment
- 106
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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