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

NCT ID: NCT03475095

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-10

Study Completion Date

2021-12-31

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) 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.

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.

Conditions

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Low Back Pain Disc, Herniated

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tuina

Intervention Type OTHER

Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.

Interventions

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Tuina

Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.

Intervention Type OTHER

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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maosheng Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang Chinese Medical University

honhquan Song, Bachelor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang Chinese Medical University

hui Wei, Bachelor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang Chinese Medical University

Locations

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The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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honggen Du, master

Role: CONTACT

+86-0571-87070217

keding Shao, master

Role: CONTACT

+86-0571-86613536

Facility Contacts

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honggen Du, MD

Role: primary

+86-057187070217

References

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Tsuji T, Matsuyama Y, Sato K, Hasegawa Y, Yimin Y, Iwata H. Epidemiology of low back pain in the elderly: correlation with lumbar lordosis. J Orthop Sci. 2001;6(4):307-11. doi: 10.1007/s007760100023.

Reference Type RESULT
PMID: 11479757 (View on PubMed)

Other Identifiers

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LDH-001

Identifier Type: -

Identifier Source: org_study_id

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