Clinical study to evaluate the efficacy and safety of heating and cooling combination therapeutic device in chronic low back pai
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001399
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Low back pain in the last 3 months (12 weeks) or more
2. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
3. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period
4. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form
1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment
2. Patients who have systematic disease (e.g. cancer, infection, etc.)
3. Skin disease in pain area (e.g. burn, ecchymosis, etc.)
4. Psychiatric disease that may affect the collected data
5. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
6. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
7. Hypersensitivity in heating and cooling stimulation
8. History of alcoholic or drug abuse within the last 12 months
9. Pregnant and lactating women
10. Participate in the other clinical trials within the last 3 months or after enroll this trial
11. When researchers evaluate that it is not appropriate to participate in this clinical test
12. Hypertension or participants who equip the electronic medical machine
13. Patients who have an acute disease
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100mm Visual Analogue Scale (VAS)
- Secondary Outcome Measures
Name Time Method Korean Oswestry disability index;Korean version of the Roland-Morris disability questionnaire;Traditional Medicine Back pain Questionnaire;Modified schöber test;Finger-to-floor distance;Finger-to-floor distance;Adverse event