pilot clinical trial to evaluate the safety and different efficacy of different wavelength of Ellise on chronic non specific low back pain

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004610

Enrollment

Registered

2020-01-07

Start date

2020-05-12

Completion date

Unknown

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The control group will receive sham invasive laser acupuncture(ILA) for 10 min and real electroacupuncture(50Hz, triangular wave) for 10 min, while 650 nm and 830 nm groups will recei

830 ILA group, 830nm wavelength: 20mW, 50Hz)for 10 min and real electroacupuncture(50Hz, triangular wave) at BL23, BL24, BL25, GB30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale	—

Secondary

Measure	Time frame
Oswestry Disability Index;European Quality of Life Five Dimension. Five Level Scale	—

Countries

Korea, Republic of

Contacts

Public ContactJaeHong Kim

Dongshin University

Outcome results