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

Pusan National University Korean Medicine Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新: 2022年4月4日

试验速览

暂无简介。

•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

发起方

Pusan National University Korean Medicine Hospital