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

March 16, 2018 updated by: The First Affiliated Hospital of Zhejiang Chinese Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: keding Shao, master
  • Phone Number: +86-0571-86613536
  • Email: knail@163.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: 6 weeks
Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.
6 weeks
Oswestry Disability Index (ODI)
Time Frame: 6 weeks
Assessment of symptoms and severity of low back pain
6 weeks
Biering-Sørensen test
Time Frame: 6 weeks
Assessment of endurance of the lumbar paraspinal muscle
6 weeks
Rapid reaction time
Time Frame: 6 weeks
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
Time Frame: 12 weeks
Intervertebral disc biomechanical analysis
12 weeks
Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
Time Frame: 12 weeks
Identification of brain activation in the motor area during Tuina.
12 weeks
Visual analogue scale (VAS)
Time Frame: 12 weeks
Assessment of pain intensity before treatment of all patients,collate related
12 weeks
Oswestry Disability Index (ODI)
Time Frame: 12 weeks
Assessment of symptoms and severity of low back pain
12 weeks
Biering-Sørensen test
Time Frame: 12 weeks
Assessment of endurance of the lumbar paraspinal muscle
12 weeks
Cross sectional area of multifidus
Time Frame: 12 weeks
Measurement of Cross Sectional Area of Multifidus will be performed on MR images
12 weeks
Rapid reaction time
Time Frame: 12 weeks
Measurement of rapid reaction time will be conducted in surface electromyo gram
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2018

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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