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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475095
• Other study ID #: LDH-001
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2018
• Last updated: March 16, 2018
• Start date: March 10, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2018
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: honggen Du, master
• Phone: +86-0571-87070217
• Email: duhonggen1212[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disc, Herniated
• Hernia
• Intervertebral Disc Displacement
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

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