Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT00343057
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2006-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2830}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2006-06-20', 'studyFirstSubmitQcDate': '2006-06-21', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Acute Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '17684553', 'type': 'DERIVED', 'citation': 'Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.'}]}, 'descriptionModule': {'briefSummary': 'To assess the impact of standardized written information on outcome in acute LBP.', 'detailedDescription': "A 3-month prospective, controlled study with a quasi-experimental design (i.e., a nonrandomized controlled sample with geographic stratification \\[30 areas\\]). Control and intervention areas ARE selected for their similarities in rural-to-urban distribution of the population and patients' access to GPs and to minimize risk of overlap between areas."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects presenting with acute common low back pain.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Each GP have to enroll up to 4 patients with acute LBP.\n\nExclusion Criteria:\n\nPatients are excluded if they\n\n1. are less than 18 years old;\n2. have pain for more than 4 weeks;\n3. have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain);\n4. have sciatica;\n5. have had a previous episode of acute LBP during the last 12 months;\n6. have no occupational activities;\n7. have consulted another practitioner for the same episode of back pain;\n8. are pregnant;\n9. have back pain related to infection, tumor, or inflammatory disease; or (j) have previously undergone back surgery.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00343057', 'briefTitle': 'DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP): a Quasi-experimental Study in a Primary Care Setting.', 'orgStudyIdInfo': {'id': 'IXP0001A_9001'}}, 'armsInterventionsModule': {'interventions': [{'name': "Patients' questionnaire", 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'COUDERC, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}