Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT01690234
Status:
UNKNOWN
Last Update Posted:
2012-09-21
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 770}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-19', 'studyFirstSubmitDate': '2012-09-19', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days off work', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Return to work', 'Sickness absence', 'Rehabilitation', 'Multidisciplinary intervention'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '36088313', 'type': 'DERIVED', 'citation': 'Fisker A, Langberg H, Petersen T, Mortensen OS. Effects of an early multidisciplinary intervention on sickness absence in patients with persistent low back pain-a randomized controlled trial. BMC Musculoskelet Disord. 2022 Sep 10;23(1):854. doi: 10.1186/s12891-022-05807-7.'}, {'pmid': '23496897', 'type': 'DERIVED', 'citation': 'Fisker A, Langberg H, Petersen T, Mortensen OS. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 13;14:93. doi: 10.1186/1471-2474-14-93.'}]}, 'descriptionModule': {'briefSummary': 'In Denmark the number of patients, sick listed for more than four weeks is increasing, and patients suffering from musculoskeletal disorders make one third of the total amount of long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. The aim of this study is to evaluate the effect of a work oriented multidisciplinary intervention.\n\nA randomized controlled trial will include 770 patients with low back pain. The study population consists of patients, who are sick listed or at risk of sick leave due to LBP.\n\nThe control group is treated with usual care in a team with participation of a physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist and a social worker from the local sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days of work. Secondary outcomes are disability, pain, and quality of life.\n\nThis large RCT study is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the sickness benefit office participating in team meetings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Working age adults 18-65\n* Low back pain (longer than 2 weeks)\n* Sicklisted or at risk\n* Employed or unemployed\n\nExclusion Criteria:\n\n* Severe comorbidity\n* Pregnancy\n* Difficulties in reading Danish language\n* Application for early retirement'}, 'identificationModule': {'nctId': 'NCT01690234', 'acronym': 'TIKI', 'briefTitle': 'Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Back and Rehabilitation Center, Copenhagen'}, 'officialTitle': 'Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-C-2008-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multidisciplinary intervention', 'description': 'Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.', 'interventionNames': ['Procedure: Multidisciplinary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Intervention from physiotherapist, chiropractor, rheumatologist and social worker.', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'Multidisciplinary intervention', 'type': 'PROCEDURE', 'description': 'Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.', 'armGroupLabels': ['Multidisciplinary intervention']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Intervention from physiotherapist, chiropractor, rheumatologist and social worker.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tom Petersen, PT, PhD', 'role': 'CONTACT', 'email': 'tom.petersen@suf.kk.dk', 'phone': '+4535304974'}, {'name': 'Inge Lis Goethgen, Head', 'role': 'CONTACT', 'email': 'MW53@suf.kk.dk', 'phone': '+4535304950'}, {'name': 'Tom Petersen, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Back and Rehabilitation Center Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Tom Petersen, PT, PhD', 'role': 'CONTACT', 'email': 'tom.petersen@suf.kk.dk', 'phone': '+4535304974'}, {'name': 'Inge Lis Goethgen, Head', 'role': 'CONTACT', 'email': 'MW53@suf.kk.dk', 'phone': '+4535304950'}], 'overallOfficials': [{'name': 'Tom Petersen, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Back and Rehabilitaion Center Copenhagen'}, {'name': 'Annette Fisker, PT, PhDstud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen, Department of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Back and Rehabilitation Center, Copenhagen', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Tom Petersen', 'investigatorAffiliation': 'Back and Rehabilitation Center, Copenhagen'}}}}