Evaluation of the safety, efficacy, and economic evaluation of complex chuna treatment versus simple chuna treatment for non-acute low back pain accompanied by pelvic deviation: randomized, accessor-blind, multicenter pilot clinical trial
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007090
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion criteria
1. patient having pelvic deviation with non-acute low back pain(onset before more than 2 weeks) and Numeric Rating Scale score above 5
2. patient who has been confirmed to have pelvic deviation by manual diagnose of Korean Medicine dictor using X-ray
3. aged above 19 and below 65
4. patient who is capable of ordinary communication
5. participant who has signed the clinical trail consent form with voluntary participation decision
Exclusion criteria
1. patient who is diagnosed with specific severe disease which could cause low back pain, or the cause of low back pain is not pelvic deviation (vertebral metastasis of tumor, acute fracture and dislocation, polio, etc.)
2. 2. patient with absolute contraindication of Chuna Manual Therapy(acute cauda equina syndrome, vertebral dislocation, cerebral aneurysm, etc.)
3. patient who is considered inappropriate for the clinical trial by the staffs(e.g. lumbosacropelvic operation history, knee operation history, innate vertebral disease, nerve root block operation history, etc.)
4. patient who has received Chuna Manual Therapy within a week, or taking medicine such as steroids, immunodepressant, mental disorder medicine, or other drugs which could affect study result(e.g.NSAIDs)
5. operation or medical procedure is scheduled which could affect judgement of clinical trial result during the treatment period
6. patient with chronic disease which could affect the effect of the clinical study : cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
7. patient who has participated other clinical trials within 1 month
8. patient who is incapable of ordinary communication because of dementia or mild cognition disorder, etc.
9. pregnant women
10. person who has difficulty with signing the clinical trial consent form or is considered incapable of carrying out the normal clinical trial procedure
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ow Back Pain Numeric Rating Scale, NRS
- Secondary Outcome Measures
Name Time Method Oswestry disability index, ODI;Patient Global Impression of Change, PGIC;Credibility and Expectancy;5-level EuroQol 5-dimension(EQ-5D-5L);EuroQol Visual Analogue Scale(EQ-VAS);12-Item Short-Form Health Survey(SF-12v2)