Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT03475095
Status:
UNKNOWN
Last Update Posted:
2018-03-23
First Post:
2018-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': '6 weeks', 'description': 'Assessment of pain intensity before treatment of all patients,collate related data and statistically analyzed.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '6 weeks', 'description': 'Assessment of symptoms and severity of low back pain'}, {'measure': 'Biering-Sørensen test', 'timeFrame': '6 weeks', 'description': 'Assessment of endurance of the lumbar paraspinal muscle'}, {'measure': 'Rapid reaction time', 'timeFrame': '6 weeks', 'description': 'Measurement of rapid reaction time will be conducted in surface electromyo gram'}], 'secondaryOutcomes': [{'measure': 'Finite element analysis', 'timeFrame': '12 weeks', 'description': 'Intervertebral disc biomechanical analysis'}, {'measure': 'Resting state functional magnetic resonance imaging and magnetic resonance spectroscopy', 'timeFrame': '12 weeks', 'description': 'Identification of brain activation in the motor area during Tuina.'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': '12 weeks', 'description': 'Assessment of pain intensity before treatment of all patients,collate related'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '12 weeks', 'description': 'Assessment of symptoms and severity of low back pain'}, {'measure': 'Biering-Sørensen test', 'timeFrame': '12 weeks', 'description': 'Assessment of endurance of the lumbar paraspinal muscle'}, {'measure': 'Cross sectional area of multifidus', 'timeFrame': '12 weeks', 'description': 'Measurement of Cross Sectional Area of Multifidus will be performed on MR images'}, {'measure': 'Rapid reaction time', 'timeFrame': '12 weeks', 'description': 'Measurement of rapid reaction time will be conducted in surface electromyo gram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'Tuina therapy', 'lumbar disc herniation', 'central motion control', 'functional magnetic resonanceimaging', 'effect mechanism', 'Chronic nonspecific low Back pain'], 'conditions': ['Low Back Pain', 'Disc, Herniated']}, 'referencesModule': {'references': [{'pmid': '11479757', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Age:25～40 years old\n* VAS score ≥30/100\n* Waist ODI index≥20%\n* Self-rating anxiety scale (SAS)\\<59 points, Self-rating Depression Scale (SDS) \\<53 points\n* BMI\\<24\n* Signed the Informed Consent Form\n\nExclusion Criteria:\n\n* History of spinal surgery or history of severe spine trauma\n* Combined with other lumbar conditions may interfere with clinical outcomes (e.g. bone tuberculosis, tumors and severe osteoporosis)\n* Combines cardiovascular disease, blood system, digestive system and other serious medical diseases or psychosis\n* Women at childbearing age and of pregnancy desire during the study\n* combined with autoimmune diseases, allergy Sexual diseases, acute and chronic infectious diseases\n* Presence of any major physical or neurological illness\n* MRI contraindication\n* MRI showed nucleus pulposus free, cauda equina syndrome\n* vision loss, vestibular dysfunction'}, 'identificationModule': {'nctId': 'NCT03475095', 'briefTitle': 'Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'A Mechanism of Tuina Treating Lumbar Disc Herniation Based of Central Nervous System Motion Control Modulating Reconstruction of Lumbar Stabilizer Function', 'orgStudyIdInfo': {'id': 'LDH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDH patients', '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.', 'interventionNames': ['Other: Tuina']}], 'interventions': [{'name': 'Tuina', 'type': 'OTHER', 'description': 'Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.', 'armGroupLabels': ['LDH patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'honggen Du, MD', 'role': 'CONTACT', 'email': 'duhonggen1212@163.com', 'phone': '+86-057187070217'}], 'facility': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'honggen Du, master', 'role': 'CONTACT', 'email': 'duhonggen1212@163.com', 'phone': '+86-0571-87070217'}, {'name': 'keding Shao, master', 'role': 'CONTACT', 'email': 'knail@163.com', 'phone': '+86-0571-86613536'}], 'overallOfficials': [{'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', 'affiliation': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}