None listed
Conditions
Interventions
Medical Device : The control group will receive sham invasive laser acupuncture(ILA) for 10 min at bilateral acupoints of BL23, BL24, BL25, GB30.
650 nm laser group will receive ILA(power output 20?,
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder Rate of low back pain with no increase in pain medications | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Oswestry Disability Index;European Quality of Life Five Dimension. Five Level Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactJaeHong Kim
Dongshin University
Outcome results
None listed