Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-03 @ 11:12 AM
Study NCT ID:
NCT00741650
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2008-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal 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'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2097}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2008-08-25', 'studyFirstSubmitQcDate': '2008-08-25', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sick Leave', 'timeFrame': '1 year and 2 year after start of intervention'}], 'secondaryOutcomes': [{'measure': 'Low Back pain', 'timeFrame': '1 year and 2 years after intervention'}, {'measure': 'Subjective Health complaints', 'timeFrame': '1 year and 2 years after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Musculoskeletal pain', 'Brief cognitive intervention', 'Cognitive behavior therapy', 'Intervention Study', 'Health prevention', 'workplace intervention'], 'conditions': ['Neck Pain Musculoskeletal', 'Back Pain Lower Back']}, 'referencesModule': {'references': [{'pmid': '23657490', 'type': 'BACKGROUND', 'citation': 'Odeen M, Ihlebaek C, Indahl A, Wormgoor ME, Lie SA, Eriksen HR. Effect of peer-based low back pain information and reassurance at the workplace on sick leave: a cluster randomized trial. J Occup Rehabil. 2013 Jun;23(2):209-19. doi: 10.1007/s10926-013-9451-z.'}, {'pmid': '23868103', 'type': 'BACKGROUND', 'citation': 'Ree E, Odeen M, Eriksen HR, Indahl A, Ihlebaek C, Hetland J, Harris A. Subjective health complaints and self-rated health: are expectancies more important than socioeconomic status and workload? Int J Behav Med. 2014 Jun;21(3):411-20. doi: 10.1007/s12529-013-9329-7.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial comparing a new approach to musculoskeletal pain consisting of education and peer involvement to treatment as usual. All local government employees in 1-3 Norwegian municipalities will be invited to participate.', 'detailedDescription': 'The purpose of the study is to systematically test a new treatment method for musculoskeletal pain in Norway. The intervention focuses on attempting to treat musculoskeletal pain outside the traditional medical system as much as possible, to avoid the establishment of a patient identity and passive patient behavior. In addition, participants are given reasons to stay active, and not advice to stay active.\n\nIbedrift is a randomized controlled trial with the aim of studying the effect of a new treatment regime for musculoskeletal pain, focusing on didactic information about low back pain with peer support. Those participants not in the control group will have the option of contacting a peer advisor, a non health professional trained by the iBedrift crew to give information about back pain and reasons to stay active. For those who have not recovered within a short period of time, and who are randomized to full treatment, the peer advisor can send them directly to health personnel for a brief intervention consisting of a medical examination with screening for conditions that need treatment, counseling and education.\n\nThe intervention was done in 2 Norwegian municipalities for all local government employees. Randomization was done at the level of working units (schools, offices etc) which allows for more message containment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All employees above 18 years\n\nExclusion Criteria:\n\n* Cancer\n* Known congenital musculoskeletal disease\n* Cauda equina syndrome'}, 'identificationModule': {'nctId': 'NCT00741650', 'acronym': 'Ibedrift', 'briefTitle': 'Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'Ibedrift- Health Related Coping. A Randomized Controlled Trial Comparing a Worksite Educational Intervention With or Without Referral to Treatment as Usual.', 'orgStudyIdInfo': {'id': '801622-611704'}, 'secondaryIdInfos': [{'id': '18997', 'type': 'OTHER', 'domain': 'NSD'}, {'id': 'S-08054b', 'type': 'OTHER', 'domain': 'REK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Information and peer advisor', 'interventionNames': ['Behavioral: Information and Peer advisor']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Information, peer advisor and referral to further treatment', 'interventionNames': ['Behavioral: Information, peer advisor and fast referral']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Information and Peer advisor', 'type': 'BEHAVIORAL', 'description': 'Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work.', 'armGroupLabels': ['1']}, {'name': 'Information, peer advisor and fast referral', 'type': 'BEHAVIORAL', 'description': 'Information at work place and recruitment and training of one employee as a peer advisor who help colleagues who experience musculoskeletal pain with reasons to stay active, help with adjustment in the work situation to allow individuals to stay at work.\n\nIn addition, the peer advisor can refer employees who do not improve to a two day educational program that also includes a medical exam and individual counselling.\n\nIn addition,', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3294', 'city': 'Stavern', 'country': 'Norway', 'facility': 'Spesialsykehuset for Rehabilitering', 'geoPoint': {'lat': 59.0, 'lon': 10.03333}}], 'overallOfficials': [{'name': 'Aage Indahl, Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital of Vestfold'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset i Vestfold HF', 'class': 'OTHER'}, {'name': 'Helse Sor-Ost', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}