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

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ClinicalTrials.gov Identifier: NCT03475095
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Disc, Herniated Other: Tuina Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function
Actual Study Start Date : March 10, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Hernia

Arm Intervention/treatment
Experimental: LDH patients
"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.
Other: Tuina
Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.




Primary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: 6 weeks ]
    Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.

  2. Oswestry Disability Index (ODI) [ Time Frame: 6 weeks ]
    Assessment of symptoms and severity of low back pain

  3. Biering-Sørensen test [ Time Frame: 6 weeks ]
    Assessment of endurance of the lumbar paraspinal muscle

  4. Rapid reaction time [ Time Frame: 6 weeks ]
    Measurement of rapid reaction time will be conducted in surface electromyo gram


Secondary Outcome Measures :
  1. Finite element analysis [ Time Frame: 12 weeks ]
    Intervertebral disc biomechanical analysis

  2. Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy [ Time Frame: 12 weeks ]
    Identification of brain activation in the motor area during Tuina.

  3. Visual analogue scale (VAS) [ Time Frame: 12 weeks ]
    Assessment of pain intensity before treatment of all patients,collate related

  4. Oswestry Disability Index (ODI) [ Time Frame: 12 weeks ]
    Assessment of symptoms and severity of low back pain

  5. Biering-Sørensen test [ Time Frame: 12 weeks ]
    Assessment of endurance of the lumbar paraspinal muscle

  6. Cross sectional area of multifidus [ Time Frame: 12 weeks ]
    Measurement of Cross Sectional Area of Multifidus will be performed on MR images

  7. Rapid reaction time [ Time Frame: 12 weeks ]
    Measurement of rapid reaction time will be conducted in surface electromyo gram



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475095


Contacts
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Contact: honggen Du, master +86-0571-87070217 duhonggen1212@163.com
Contact: keding Shao, master +86-0571-86613536 knail@163.com

Locations
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China, Zhejiang
The First Affiliated Hospital of Zhejiang Chinese Medical University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: honggen Du, MD    +86-057187070217    duhonggen1212@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University
Investigators
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Principal Investigator: maosheng Xu, Doctor The First Affiliated Hospital of Zhejiang Chinese Medical University
Principal Investigator: honhquan Song, Bachelor The First Affiliated Hospital of Zhejiang Chinese Medical University
Principal Investigator: hui Wei, Bachelor The First Affiliated Hospital of Zhejiang Chinese Medical University

Publications of Results:
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Responsible Party: The First Affiliated Hospital of Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT03475095     History of Changes
Other Study ID Numbers: LDH-001
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The First Affiliated Hospital of Zhejiang Chinese Medical University:
Low Back Pain
Tuina therapy
lumbar disc herniation
central motion control
functional magnetic resonanceimaging
effect mechanism
Chronic nonspecific low Back pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Hernia
Intervertebral Disc Displacement
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases