Status:
UNKNOWN
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
Lead Sponsor:
Eun Jung Kim
Collaborating Sponsors:
Ministry of Health & Welfare, Korea
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
The purpose of this study is to verify the efficacy and safety of heating and cooling combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).
Detailed Description
The investigators targeted the patients with chronic LBP. After treatment in 2 groups - real heating and cooling combination treatment and sham heating and cooling combination treatment - the investig...
Eligibility Criteria
Inclusion
- At least 20 years of age, but below 75 years of age
- Low back pain in the last 3 months or more
- Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
- Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
- An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.
Exclusion
- Trauma to or surgery on the lumbar region within 6 months prior to enrollment
- Low back pain accompanied by sciatica
- Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
- A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
- Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
- Hypersensitivity in heating and cooling stimulation
- Pregnant and lactating women
- Participate in the other clinical trials within the last 3 months or after enroll this trial
- When researchers evaluate that it is not appropriate to participate in this clinical test
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02289170
Start Date
September 1 2014
End Date
September 1 2015
Last Update
November 13 2014
Active Locations (1)
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1
Donnguk University Oriental Medical Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-865