Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation
A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Mar 2018
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2018
CompletedFirst Submitted
Initial submission to the registry
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 23, 2018
March 1, 2018
1.2 years
March 12, 2018
March 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
Finite element analysis
12 weeks
Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
12 weeks
Visual analogue scale (VAS)
12 weeks
Oswestry Disability Index (ODI)
12 weeks
Biering-Sørensen test
12 weeks
- +2 more secondary outcomes
Study Arms (1)
LDH patients
EXPERIMENTAL"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.
Interventions
Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006, China
Related Publications (1)
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.
PMID: 11479757RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2018
First Posted
March 23, 2018
Study Start
March 10, 2018
Primary Completion
May 31, 2019
Study Completion
December 31, 2021
Last Updated
March 23, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share