The Efficacy of Radiofrequency-Thermal Stimulation in Acupoints for Chronic Low Back Pain: A Preliminary Study of a Randomized, Patient-Blinded, Placebo Control Trial.
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002137
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 56
1. Patients with a minimum pain intensity score greater than 30 mm on a visual analogue scale (VAS, 0 to 100 mm)
2. Diagnosed as the low back pain with medical evidences (e.g. previous radiographic records and independent physical examination)
3. Voluntary participation who clearly understood purpose and characteristics of the clinical trials signed informed consent form
1. Patients who required the aid of medical devices or attached implantable equipment that could be affected by electromagnetic fields, such as pacemakers or hearing aids
2. Unendurable pain, bone fractures, severe disc herniation, or spinal tumours.
3. Taking drugs such as corticosteroids, anticonvulsants, or anti-inflammatory agents.
4. Pregnancy
5. Patients who experienced any adverse effects due to the physical stimulation therapy
6. Cognitive or mental dysfunction
7. Participated in other clinical trials within the last month
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in visual analogue scale (VAS, 100 mm) from the baseline to follow-up period
- Secondary Outcome Measures
Name Time Method Change of pressure pain threshold (PPT) ;Change of patient's global impression of change (PGIC) ;European Quality of Life-5 Dimensions (EQ-5D)