Effects of acupuncture on the signal changes in the primary sensory cortex for patients with lumbar disc herniation or lumbar spinal stenosis with radiating leg pain: a parallel randomised controlled multicentre exploratory trial and a cross-sectional study

Pusan National University Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年12月2日

适应症

试验速览

暂无简介。

•1. Patient group
•1) 19 to 75 years
•2) Over 3 months after diagnosis of lumbar disc herniation or lumbar spinal stenosis.
•3) Patient who submits document proving selection criterion 2).
•4) Radiating leg pain numeric rating scale score of at least 4 over the last week.
•5) Voluntary written consent to the subject consent form.
•2. Normal group
•1) 30 to 75 years
•2) No back pain and lower back pain over the last 3 months
•3) No other pain
•4) MRI (magnetic resonance imaging) available

•1. Patient group
•1) History/Current history of fracture, tumor or infection of lumbar spine
•2) Those who need emergency surgery due to cauda equina syndrome or those with neurological abnormalities lasting 1 month.
•3) Those who have undergone surgery on the back area
•4) Those who have been treated for lumbar disc herniation or lumbar spinal stenosis within one week of the screening visit
•5) MRI examination not possible
•6) Seriously unstable medical condition or serious psychiatric illness
•7) Diseases that cause brain damage or severe pain
•8) Psychotropic drugs (excluding non-toxic analgesics)
•9) Pregnant women, nursing mothers
•10) Hypersensitivity to acupuncture
•11) Participating in other clinical studies
•12) Residents of collective dwelling facilities such as social welfare institutions
•13) Difficult to cooperate in the research process.
•2. Normal group
•1) Pregnant women, nursing mothers
•2) Participating in other clinical studies
•3) Diseases that cause brain damage or severe pain
•4) Drugs that affect brain activation (psychotropic medications, antipyretics, etc.)

发起方