Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-02 @ 11:33 AM
Study NCT ID:
NCT00478868
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-26', 'studyFirstSubmitDate': '2007-05-24', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modic change', 'timeFrame': 'Upon assessment', 'description': 'Modic change type, extension and volume'}], 'secondaryOutcomes': [{'measure': "Patients' characteristics", 'timeFrame': 'Upon assessment', 'description': 'Gender, age, body mass index (BMI), life time smoking exposure, and degree of physical activity'}, {'measure': 'Image features', 'timeFrame': 'Upon assessment', 'description': 'Disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MODIC changes', 'chronic low back pain', 'magnetic resonance imaging (MRI)', 'vertebrae', 'intervertebral disc'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '3336678', 'type': 'BACKGROUND', 'citation': 'Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. doi: 10.1148/radiology.166.1.3336678.'}, {'pmid': '8083266', 'type': 'BACKGROUND', 'citation': 'Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.'}, {'pmid': '11438138', 'type': 'BACKGROUND', 'citation': 'Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and radiological findings associated with Modic changes.', 'detailedDescription': "Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487 adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes.\n\nOutcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree of physical activity, and image features (disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen for chronic low back pain at the hospitals of the Spanish National Health Service.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 35 and 50 years of age having a diagnosis of chronic low back pain (of 3 or more months' duration, and including sciatica and lumbar cytalgia), who get a prescription for an MRI.\n\nExclusion Criteria:\n\n* Racial characteristics suggesting a non-Spanish origin; central nervous system pathology (with or without treatment);\n* Diagnosis or suspicion of systemic disease (inflammatory disease such as rheumatoid arthritis, or infections)."}, 'identificationModule': {'nctId': 'NCT00478868', 'acronym': 'MODIC', 'briefTitle': 'Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients', 'orgStudyIdInfo': {'id': 'FK-R-15'}}, 'contactsLocationsModule': {'locations': [{'zip': '07012', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Kovacs Foundation', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Francisco M Kovacs, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kovacs Foundation, Palma de Mallorca, Spain'}, {'name': 'Carlos Campillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IbSalut, Palma de Mallorca, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francisco M. Kovacs, Director of Scientific Department', 'oldOrganization': 'Kovacs Foundation'}}}}