Clinical trial to evaluate the efficacy and safety of MS-980S medical device in patients with chronic low back pai
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003122
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
1. An adult male and female who are over 19 years of age. Patients with back pain over 3 months(12weeks)
2. Paitents with over 40 score on100mm Visual Analoges Scale (VAS)
3. A patient who fully understands of the test and the risks involved in taking the test and is able to communicate with the examiner well and follow the test compliance
4. The person who signed the agreement with the explanation of the purpose, method and effect of the clinical trial
1. Patients with a history of trauma and surgery in the last 6 months
2. Patients with systemic diseases that cause chronic back pain (cancer, infection, etc.)
3. Patients with burns, tattoos, subcutaneous haemorrhage, and severe skin conditions requiring clinical treatment
4. Mental illness to affect pain and questionnaire
5. Those who have received chronic back pain treatment (medication, korean medicine, physical therapy, etc.) during the last 4 weeks
6. Patients with neurological disease (stroke, peripheral neuropathy, etc.) whose sensation of temperature is poor due to paralysis in local or systemic sensations
7. Subjects with hypersensitivity to thermal stimulation, laser, and high frequency
8. People with a history of alcohol or substance abuse within 12 months
9. Infants, pregnant women, people with a pregnancy plan, lactating women
10. Those who have participated in other clinical trials after this clinical trial enrollment/ Those who participated in clinical trials for back pain within 3 months
11. Those using electronic medical devices for hypertension and electrocardiograph
12.Those who were considered as unsuitable for participation by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100mm VAS(visual analoge scale)
- Secondary Outcome Measures
Name Time Method Ratio of subjects whose 100mm VAS(visual analoge scale) has decreased by more than 50%;Change of ODI (Oswestry Low Back Pain Disability Questionnaire/Oswestry Disability Index);Change of SF(Short-Foam) 36 health survey;Patient satisfaction survey