Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-05 @ 6:12 PM
Study NCT ID:
NCT00477568
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'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', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2007-05-22', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Wheelchair users', 'Back pain', 'Prevalence', 'Risk factors'], 'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of Spain. Another study objective is the identification of risk factors for back pain in this population. Data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Wheelchair users who do so on a constant basis (not occasional).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with established disability;\n* Permanent wheelchair users;\n* Having physical and intellectual ability to answer questionnaire.\n\nExclusion Criteria:\n\n* Transitory wheelchair users;\n* Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;\n* Red flags for systemic disease.'}, 'identificationModule': {'nctId': 'NCT00477568', 'briefTitle': 'Back Pain Prevalence in Wheelchair Users and Associated Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'Back Pain Prevalence in Wheelchair Users and Associated Risk Factors', 'orgStudyIdInfo': {'id': 'FK-R-14'}}, 'contactsLocationsModule': {'locations': [{'zip': '07012', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Fundación Kovacs', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Island', 'country': 'Spain', 'facility': 'Instituto de Asuntos Sociales y Deportes de Mallorca', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Francisco M Kovacs, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unidad de la Espalda Kovacs, Hospital Universitario HLA-Moncloa'}, {'name': 'Juan Noguera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallorca Institute of Social Affairs', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Scientific Department, Kovacs Foundation', 'investigatorFullName': 'Francisco M. Kovacs', 'investigatorAffiliation': 'Kovacs Foundation'}}}}