Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-31 @ 7:23 PM
Study NCT ID:
NCT05649592
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-06', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'core muscles percent fat', 'timeFrame': 'baseline', 'description': 'Magnetic resonance imaging-guided core muscles percent fat in patients with chronic LDH and healthy volunteers, including erector spinae, rectus abdominis, (transversus abdominal, internal abdominal oblique, and external abdominal oblique muscle), lumbar multifidus, and psoas major muscles was used as the outcome measure'}], 'secondaryOutcomes': [{'measure': 'Subcutaneous fat tissue thickness', 'timeFrame': 'baseline', 'description': 'Subcutaneous fat tissue thickness(SFTT) was measured as the vertical distance from the tip of spinous process to the skin on axial T2-weighted lumbar spine MRI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'Fat infiltration and atrophy of lumbar muscles are related to spinal degenerative conditions, which can be seen reliably on MRI scans of lumbar disc herniation (LDH) patients. The aim of this study was to investigate the relationship between the degeneration of core muscles, obesity and chronic LDH. Fifty-five healthy volunteers and fifty-five chronic LDH patients (the course of the disease is more than six months) were enrolled. Core muscle percent fat and subcutaneous fat tissue thickness(SFTT) were used as the outcome measure, and logistic regression and independent samples t-test as the analytical methods to compare the relationship of the following five independent variables (erector spinae, rectus abdominis, \\[transversus abdominal, internal abdominal oblique, and external abdominal oblique muscle\\], lumbar multifidus, and psoas major muscles) and SFTT with LDH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n①patients who meet the diagnostic criteria for LDH based on overall consideration of their symptoms, signs, and radiological findings (MRI)； ②patients aged 20 to 55 years, including 20 and 55 years, male or female; ③Patients with a history of LDH for 6 months and/or above; ④patients who have signed the informed consent.\n\nExclusion criteria:\n\n①patients with LDH causing radiculopathy or cauda equina syndrome; ②patients with other diseases such as spinal stenosis, ankylosing spondylitis that causes low back pain; ③patients with a previous history of spinal surgery, traumatic injury to the spine; ④patients with bone tuberculosis, osteoporosis and bone tumors; ⑤patients with other severe cardiovascular and cerebrovascular diseases, digestive and hematopoietic system diseases; patients with diabetes mellitus Autoimmune diseases or other metabolic diseases; patients with mental diseases;', 'genderDescription': 'patients and healthy volunteers aged 20 to 55 years, including 20 and 55 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in good physical health; ②patients aged 20 to 55 years, including 20 and 55 years, male or female; ③patients who agree to participate in the study and sign the informed consent.\n\nExclusion criteria:\n\n* patients who performed lumbar and abdominal muscles exercises in the past; ②patients unable to tolerate magnetic resonance imaging or claustrophobia;\n\n * patients who are deemed unsuitable for the clinical trial.\n\nRemoving criteria:\n\n* patients who decline participation of various reasons;\n\n * patients unable to comprehend questions asked by the researchers; ③patients intolerant to necessary examinations.'}, 'identificationModule': {'nctId': 'NCT05649592', 'acronym': 'ICCLDHPCMSFT', 'briefTitle': 'Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness', 'organization': {'class': 'OTHER', 'fullName': 'ShuGuang Hospital'}, 'officialTitle': 'Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness: an Observational Study', 'orgStudyIdInfo': {'id': '3568185739'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar disc herniation patients', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Hydrolipid Separation Imaging']}, {'label': 'healthy volunteers', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Hydrolipid Separation Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Hydrolipid Separation Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRHS was used to measure different muscle percent fat of core muscles. MRHS, also called Dixon imaging, mainly used the different resonant frequency between the hydrogen nuclei in water and in fat to perform the data acquisition at different echo times (TE). The Dixon sequence basically acquires two images, one image with water and fat signals in-phase and the other with water and fat signals out-of-phase: the sum and subtraction of the two images allow the production of a water-only image and a fat-only image. Scanning equipment: 3.0T superconducting Siemens Skyra Scanner.\n\nScanning parameters: TR5.36ms, TE1.24ms, Flip Angle 9°, number of layers was 44-60, thickness of layer was 5.0 mm, layer interval 1.0mm, FOV50cm×50cm, the scanning time was 12s×5.', 'armGroupLabels': ['Lumbar disc herniation patients', 'healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201203', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shuguang Hospital Affiliated with Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhan Yunfan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'ShuGuang Hospita', 'investigatorFullName': 'Zhan Yunfan', 'investigatorAffiliation': 'ShuGuang Hospital'}}}}