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A randomized, open-label, assessment–blind, parallel designed pilot clinical study to evaluate the efficacy and safety of Laser with RF Moxibustion Unit(COT-C1) in patients with chronic low back pain

A randomized, open-label, assessment–blind, parallel designed pilot clinical study to evaluate the efficacy and safety of Laser with RF Moxibustion Unit(COT-C1) in patients with chronic low back pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002371
Enrollment
40
Registered
2017-07-07
Start date
2017-07-24
Completion date
Unknown
Last updated
2019-03-11

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 treatment is applied 10 times for 4 weeks. Most painful 4 points in 8 acupuncture points by the same selection method is used for all the patients assigned to this study. The trea

Sponsors

Dongguk University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 20 years of age, but below 75 years of age 2. Low back pain in the last 3 months(12 weeks) or more 3. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS) 4. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period. 5. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.

Exclusion criteria

Exclusion criteria: 1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment 2. Low back pain accompanied by sciatica 3. Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.) 4. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks 5. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.) 6. Hypersensitivity in heating stimulation, laser therapy and high frequency therapy 7. Pregnant and lactating women 8. Participate in the other clinical trials within the last 3 months or after enroll this trial 9. When researchers evaluate that it is not appropriate to participate in this clinical test

Design outcomes

Primary

MeasureTime frame
100mm Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
Korean Oswestry disability index(KODI);Korean Roland-Morris Disability Questionnaire (KRMDQ);100mm Visual Analogue Scale (VAS);Adverse event

Countries

Korea, Republic of

Contacts

Public ContactCHANYUNG JUNG

Dongguk University

yyoung81@hanmail.net+82-31-961-9074

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026