Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-20 @ 2:53 PM
Study NCT ID:
NCT02351206
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The distance between the 2 midpoints of the inferior and superior borders of the vertebral bodies surrounding the L4/5 intervertebral disc space divided by the AP diameter of the inferior border of the L4 vertebral body', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['X-Rays', 'Magnetic Resonance Imaging', 'Sensitivity and Specificity'], 'conditions': ['Intervertebral Disc Displacement', 'Intervertebral Disc Degeneration', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (LDH) and degeneration in LBP patients in their early 20s.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting Jaseng hospital of Korean Medicine, a spine specializing Korean medicine hospital designated by the Korean ministry of health and welfare, from January, 2010 to October 2014', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 20-25 years\n* L-spine X-ray and L-spine MRIs taken within a week of the other test\n* Native Korean ethnicity\n\nExclusion Criteria:\n\n* Scoliosis with a Cobb's angle of ≥20°\n* Significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm)\n* Previous spinal surgery"}, 'identificationModule': {'nctId': 'NCT02351206', 'briefTitle': 'Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jaseng Hospital of Korean Medicine'}, 'officialTitle': 'Lumbar Intervertebral Disc Space Height in Disc Herniation and Degeneration Patients in Their Early 20s', 'orgStudyIdInfo': {'id': 'JS-CT-2014-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The experimental group', 'description': 'Patients with intervertebral disc protrusion, extrusion, or migration at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test.', 'interventionNames': ['Radiation: x-ray, MRI']}, {'label': 'The control group', 'description': 'Patients with normal or disc bulging readings at L4/5 randomly selected from a population pool of 665 patients with L-spine X-ray and L-spine MRIs taken within a week of the other test.', 'interventionNames': ['Radiation: x-ray, MRI']}], 'interventions': [{'name': 'x-ray, MRI', 'type': 'RADIATION', 'armGroupLabels': ['The control group', 'The experimental group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaseng Hospital of Korean Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}