Low Back PainNCT03475095
Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation
A study testing Tuina in people with Low Back Pain and Disc, Herniated, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Disc, Herniated
- What is being tested?
- Tuina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- MRI contraindication
- MRI showed nucleus pulposus free, cauda equina syndrome
- vision loss, vestibular dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
honggen Du, MD, +86-057187070217, duhonggen1212@163.com
About this study
Official title: A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function
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.
Read the 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.
- Conditions
- Low Back Pain, Disc, Herniated
- Being tested
- Tuina
- Keywords
- Low Back Pain, Tuina therapy, lumbar disc herniation, central motion control, functional magnetic resonanceimaging, effect mechanism, Chronic nonspecific low Back pain
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TuinaOther
Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tuina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.
Measured: 6 weeks
Oswestry Disability Index (ODI)
Assessment of symptoms and severity of low back pain
Measured: 6 weeks
Biering-Sørensen test
Assessment of endurance of the lumbar paraspinal muscle
Measured: 6 weeks
Rapid reaction time
Measurement of rapid reaction time will be conducted in surface electromyo gram
Measured: 6 weeks
Secondary outcomes (7)
Finite element analysis
Intervertebral disc biomechanical analysis
Measured: 12 weeks
Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
Identification of brain activation in the motor area during Tuina.
Measured: 12 weeks
Visual analogue scale (VAS)
Assessment of pain intensity before treatment of all patients,collate related
Measured: 12 weeks
Oswestry Disability Index (ODI)
Assessment of symptoms and severity of low back pain
Measured: 12 weeks
Biering-Sørensen test
Assessment of endurance of the lumbar paraspinal muscle
Measured: 12 weeks
Cross sectional area of multifidus
Measurement of Cross Sectional Area of Multifidus will be performed on MR images
Measured: 12 weeks
Rapid reaction time
Measurement of rapid reaction time will be conducted in surface electromyo gram
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start10 Mar 2018
- Primary completion31 May 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maosheng Xu, Doctor, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical Universityhonhquan Song, Bachelor, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical Universityhui Wei, Bachelor, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475095
- Sponsor's protocol ID
- LDH-001
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11479757
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function
- ClinicalTrials.gov ID
- NCT03475095
- Acronym / sponsor ID
- LDH-001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDH patients | Experimental | Other: Tuina"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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TuinaPatients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks. | Other | LDH patients |
Primary outcome
Visual analogue scale (VAS)
Time frame: 6 weeks
Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.
Oswestry Disability Index (ODI)
Time frame: 6 weeks
Assessment of symptoms and severity of low back pain
Biering-Sørensen test
Time frame: 6 weeks
Assessment of endurance of the lumbar paraspinal muscle
Rapid reaction time
Time frame: 6 weeks
Measurement of rapid reaction time will be conducted in surface electromyo gram
7 secondary outcomes
Finite element analysis
Time frame: 12 weeks
Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy
Time frame: 12 weeks
Visual analogue scale (VAS)
Time frame: 12 weeks
Oswestry Disability Index (ODI)
Time frame: 12 weeks
Biering-Sørensen test
Time frame: 12 weeks
Cross sectional area of multifidus
Time frame: 12 weeks
Rapid reaction time
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Results publication: PubMed 11479757Tsuji 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maosheng Xu, Doctor principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
honhquan Song, Bachelor principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
hui Wei, Bachelor principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuina in people with Low Back Pain and Disc, Herniated, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact honggen Du, master (+86-0571-87070217, duhonggen1212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.