跳至主要内容
临床试验/NCT03475095
NCT03475095Unknown不适用

A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function

The First Affiliated Hospital of Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Biering-Sørensen test

研究概览

简要总结

Lumbar disk herniation (LDH)is a prevalent health problem around the world. It can cause symptoms of low back pain, numbness or weakness.The understanding of low back pain in traditional Chinese medicine(TCM) theory"unbalanced bones and muscles"that is consistent with the description of modern medicine on LDH function pathology. Tuina is one of Diagnosis and treatment methods in TCM which has been used as a noninvasive treatment of LDH. However, the mechanism of Tuina therapy in LDH is still unclear.The purpose of this study is to establish a platform of the therapeutic effect and mechanical effect of LDH in the treatment of LDH,explore the characteristics of Tuina by the motor control in lumbar CNS,observe the patterns and regularities in the function of related brain regionin of patients with acute or chronic LDH and reveal the mechanism of Tuina of improving the control of lumbar spine CNS movement.

详细描述

Clinical researches has demonstrated the effectiveness of Tuina on lumbar disc herniation (LDH), but the mechanism remains unclear.The existing researches mainly focus on the mechanical mechanism of the local stability reconstruction of the lumbar spine. Our previous study found that LDH patients have lumbar CNS motion control disorder, and preliminary studies have shown that Tuina can improve the lumbar CNS motion control efficiency, also fMRI studies found that abnormal motion related brain areas had an active trend during the acute phase and a suppressed trend in the chronic period.Therefore,we hypothesize that Tuina could improve the lumbar CNS motion control in LDH patients, and could response to the effect of local mechanical lumbar as well as bidirectionally regulate the function of lumbar stabilizers, which facilitates the stable reconstruction of lumbar. This project will illuminate the effect of Tuina improving the lumbar CNS motion control by applying the latest fMRI, surface electromyography and data mining technology to the acute and chronic LDH patients with a combination of efficacy and experimental verification to reveal the mechanism of CNS bidirectional regulation of paraspinal muscle activity by the response of related brain regions to mechanical effects after Tuina on the lumbar. This project provides a new thinking to the research of the therapeutic mechanism of LDH, which is a scientific significance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • accord with the diagnostic criteria of lumbar disc herniation in the seventh edition of "Surgery", and diagnosed by MRI, the course of acute patients ≤ 1 month, the course of chronic patients ≥ 3 months
  • Age:25~40 years old
  • VAS score ≥30/100
  • Waist ODI index≥20%
  • Self-rating anxiety scale (SAS)<59 points, Self-rating Depression Scale (SDS) <53 points
  • Signed the Informed Consent Form

排除标准

  • History of spinal surgery or history of severe spine trauma
  • Combined with other lumbar conditions may interfere with clinical outcomes (e.g. bone tuberculosis, tumors and severe osteoporosis)
  • Combines cardiovascular disease, blood system, digestive system and other serious medical diseases or psychosis
  • Women at childbearing age and of pregnancy desire during the study
  • combined with autoimmune diseases, allergy Sexual diseases, acute and chronic infectious diseases
  • Presence of any major physical or neurological illness
  • MRI contraindication
  • MRI showed nucleus pulposus free, cauda equina syndrome
  • vision loss, vestibular dysfunction

研究组 & 干预措施

LDH patients

Experimental

"ribs and bones" Tuina therapy According to the diagnostic criteria of"vertebral dislocation",determine the position,degree and direction of the dislocation,assess the activity of the affected vertebrae.Treated with combining Tuina of muscle-loosing and bone-setting such as reinforcing ribs,kneading and plucking method,20 min every treatment,twice a week for a total time of 4 weeks.

干预措施: Tuina (Other)

结局指标

主要结局

Biering-Sørensen test

时间窗: 6 weeks

Assessment of endurance of the lumbar paraspinal muscle

Visual analogue scale (VAS)

时间窗: 6 weeks

Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.

Oswestry Disability Index (ODI)

时间窗: 6 weeks

Assessment of symptoms and severity of low back pain

Rapid reaction time

时间窗: 6 weeks

Measurement of rapid reaction time will be conducted in surface electromyo gram

次要结局

  • Oswestry Disability Index (ODI)(12 weeks)
  • Cross sectional area of multifidus(12 weeks)
  • Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy(12 weeks)
  • Visual analogue scale (VAS)(12 weeks)
  • Finite element analysis(12 weeks)
  • Biering-Sørensen test(12 weeks)
  • Rapid reaction time(12 weeks)

研究者

发起方
The First Affiliated Hospital of Zhejiang Chinese Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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