Efficacy and Safety of Thread Embedding Therapy for Chronic Low Back Pain: A randomized, controlled, assessor-blinded, multicenter clinical trial
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002666
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
1. Male and female subjects aged from 19 to 65
2. Low Back Pain which lasted more than 3 months is main chief complaint
3. Pain and discomfort due to low back pain is greater than 4 on the 10-cm visual analog scale (VAS) for one week before the enrollment
4. Participants who signed the agreed consent to follow instructions voluntarily after listening to the detailed explanation of this clinical trial
1. Persons who have history of hypersensitive reactions of embedding therapy or acupuncture treatment
2. Those who have abnormalities in the lower neurological examination
3. Those who have cauda equine syndrome or neurological symptoms of sensory or motor paralysis which need surgical treatments.
4. Those who have history of the spinal surgery or plans for surgery during the clinical trial period
5. Neuromuscular scoliosis or neurodegenerative disease
6. Those with diagnosed diseases which can be the possible cause of back pain: vertebral fracture, inflammatory spondylitis, spinal infection, malignant tumor, etc.
7. Female subects who are pregnant, or are brease-feeding or has plans for pregnancy plan, or does not consent to the choice of appropriate method of contraception.
8. Those who received acupuncture, medication, physical therapy, or manipulation therapy related to back pain within the last 2 weeks
9. Those taking anticoagulants
10. Those who have more severe pain in another area other than the low back area
11. If clinical trial investigators judges that it is inappropriate for the subject to be enrolled for a fair reason
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pain scores (VAS)
- Secondary Outcome Measures
Name Time Method Change of pain scores (VAS);the clinical relevances (MCID, reduction ratio of 2 points or more on VAS compared to the 0 week (V1);the clinical relevances (MCID, reduction ratio of VAS 30% or more compared to the 0 week (V1);the clinical relevances (MCID, reduction ratio of VAS 50% or more compared to the 0 week (V1);Change of Roland and Morris Disability Questionnaire (RMDQ) scores;Change of EuroQol (EQ-5D) scores; Change of Patient Global Impression of Change;Cost-benefit analysis and cost-effectiveness analysis between the two groups.