Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT03303261
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study On Discopathie With Modic 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The principal investigator decided to stop the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain VAS ( VISUAL ANALOGIC SCORE)', 'timeFrame': 'Day 1 - Day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Hernia']}, 'descriptionModule': {'briefSummary': 'The chronic lumbago can be associated with an active discopathie, objectified on the MRI by the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing the pathological vertebral disk The treatment recommended by t consists in particular of a local infiltration of corticoids which the efficiency is variable according to the patients. The objective of this study is to estimate the efficiency of the local treatment and to highlight some of the factors associated to the advantage of the infiltration by corticoids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient hospitalized in GHPSJ for infiltration', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted in Rhumatology service for intra-disc infiltration\n* Chronic pain (\\>3 monts)\n* VAS \\>3\n* MRI stipulating MODIC 1\n\nExclusion Criteria:\n\n* radiculalgy\n* radicular VAS\\< lumbar VAS\n* pregnancy\n* local infection\n* corticoid allergy\n* previous rachial surgery\n* previous spondylodiscite\n* psychiatric disorder\n* MRI contraindication'}, 'identificationModule': {'nctId': 'NCT03303261', 'briefTitle': 'Study On Discopathie With Modic 1', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Study On Discopathie With Modic 1', 'orgStudyIdInfo': {'id': 'MODIC 1 PRO'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'COHEN SOLAL P Julien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}