search
Back to results

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

Primary Purpose

Low Back Pain, Disc, Herniated

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tuina
Sponsored by
The First Affiliated Hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Low Back Pain, Tuina therapy, lumbar disc herniation, central motion control, functional magnetic resonanceimaging, effect mechanism, Chronic nonspecific low Back pain

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDH patients

Arm Description

"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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2018
Last Updated
March 16, 2018
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03475095
Brief Title
Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation
Official Title
A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disc, Herniated
Keywords
Low Back Pain, Tuina therapy, lumbar disc herniation, central motion control, functional magnetic resonanceimaging, effect mechanism, Chronic nonspecific low Back pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDH patients
Arm Type
Experimental
Arm Description
"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.
Intervention Type
Other
Intervention Name(s)
Tuina
Intervention Description
Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.
Time Frame
6 weeks
Title
Oswestry Disability Index (ODI)
Description
Assessment of symptoms and severity of low back pain
Time Frame
6 weeks
Title
Biering-Sørensen test
Description
Assessment of endurance of the lumbar paraspinal muscle
Time Frame
6 weeks
Title
Rapid reaction time
Description
Measurement of rapid reaction time will be conducted in surface electromyo gram
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Finite element analysis
Description
Intervertebral disc biomechanical analysis
Time Frame
12 weeks
Title
Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
Description
Identification of brain activation in the motor area during Tuina.
Time Frame
12 weeks
Title
Visual analogue scale (VAS)
Description
Assessment of pain intensity before treatment of all patients,collate related
Time Frame
12 weeks
Title
Oswestry Disability Index (ODI)
Description
Assessment of symptoms and severity of low back pain
Time Frame
12 weeks
Title
Biering-Sørensen test
Description
Assessment of endurance of the lumbar paraspinal muscle
Time Frame
12 weeks
Title
Cross sectional area of multifidus
Description
Measurement of Cross Sectional Area of Multifidus will be performed on MR images
Time Frame
12 weeks
Title
Rapid reaction time
Description
Measurement of rapid reaction time will be conducted in surface electromyo gram
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
honggen Du, master
Phone
+86-0571-87070217
Email
duhonggen1212@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
keding Shao, master
Phone
+86-0571-86613536
Email
knail@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maosheng Xu, Doctor
Organizational Affiliation
The First Affiliated Hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
honhquan Song, Bachelor
Organizational Affiliation
The First Affiliated Hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
hui Wei, Bachelor
Organizational Affiliation
The First Affiliated Hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
honggen Du, MD
Phone
+86-057187070217
Email
duhonggen1212@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11479757
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs