Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation

Study Overview
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Brief Summary
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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) theoryunbalanced bones and musclesthat 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.

Detailed Description
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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.

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

Conditions
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Low Back Pain, Disc, Herniated

Intervention / Treatment
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* Other: Tuina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 BMI<24 Signed the Informed Consent Form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDH patients<br>ribs and bones Tuina therapy According to the diagnostic criteria ofvertebral 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. | Other: Tuina<br>* Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed. | 6 weeks | 
| Oswestry Disability Index (ODI) | Assessment of symptoms and severity of low back pain | 6 weeks | 
| Biering-Sørensen test | Assessment of endurance of the lumbar paraspinal muscle | 6 weeks | 
| Rapid reaction time | Measurement of rapid reaction time will be conducted in surface electromyo gram | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finite element analysis | Intervertebral disc biomechanical analysis | 12 weeks | 
| Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy | Identification of brain activation in the motor area during Tuina. | 12 weeks | 
| Visual analogue scale (VAS) | Assessment of pain intensity before treatment of all patients,collate related | 12 weeks | 
| Oswestry Disability Index (ODI) | Assessment of symptoms and severity of low back pain | 12 weeks | 
| Biering-Sørensen test | Assessment of endurance of the lumbar paraspinal muscle | 12 weeks | 
| Cross sectional area of multifidus | Measurement of Cross Sectional Area of Multifidus will be performed on MR images | 12 weeks | 
| Rapid reaction time | Measurement of rapid reaction time will be conducted in surface electromyo gram | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effect mechanism, Low Back Pain, Tuina therapy, lumbar disc herniation, central motion control, functional magnetic resonanceimaging, Chronic nonspecific low Back pain