Clinical trial NCT03475095: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 6 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 6 weeks
measure: Biering-Sørensen test
timeFrame: 6 weeks
measure: Rapid reaction time
timeFrame: 6 weeks
Secondary outcomes:
measure: Finite element analysis
timeFrame: 12 weeks
measure: Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
timeFrame: 12 weeks
measure: Visual analogue scale (VAS)
timeFrame: 12 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 12 weeks
measure: Biering-Sørensen test
timeFrame: 12 weeks
measure: Cross sectional area of multifidus
timeFrame: 12 weeks
measure: Rapid reaction time
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: maosheng Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: honhquan Song, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: hui Wei, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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.