A comparative study of the treatment of pelvic lesions in patients with non-acute low back pain.
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009210
- 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
- 81
Inclusion criteria
1. Patients with non-acute low back pain (lasting more than 2 weeks after onset) accompanied by pelvic misalignment and a pain score of Numeric Rating Scale (NRS) 5 or higher.
2. Patients diagnosed with pelvic deviation through manual diagnosis by a Korean Medicine Rehabilitation Medicine specialist with more than 2 years of clinical experience, and identified as having pelvic misalignment within the abnormal range (1SD = or = -1SD) through 3D body analysis.
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(Observational studies without intervention in other clinical studies, and clinical studies that are judged to have little correlation with Chuna and are therefore unlikely to have an impact on this study are excluded.)
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; 3D Body Shape Analysis Indicators;5-level EuroQol 5-dimension; EQ-5D-5L;EuroQol Visual Analogue Scale; EQ-VAS;12-Item Short-Form Health Survey; SF-12v2;Cost Data Investigation; Economic Evaluation Indicators