Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 2:58 PM
Study NCT ID:
NCT02967705
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Management Groups in Occupational Health Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Change in pain intensity from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, 1-item question, scale 0-10, n=60'}, {'measure': 'Pain self-efficacy', 'timeFrame': 'Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60'}, {'measure': 'Chronic pain acceptance', 'timeFrame': 'Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60'}, {'measure': 'Fear-avoidance beliefs', 'timeFrame': 'Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18'}, {'measure': 'Depressive symptoms', 'timeFrame': 'Change in depressive symptoms from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, 1-item question, response scale 0-10, n=60'}, {'measure': 'Sleep problems', 'timeFrame': 'Change in sleep problems from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, 1-item question, response scale 0-10, n=60'}, {'measure': 'Work ability', 'timeFrame': 'Change in work ability from before intervention to immediately after intervention and at 6 months', 'description': 'self-reported questionnaire, 1-item question, response scale 0-10, n=60'}], 'secondaryOutcomes': [{'measure': 'sickness absence', 'timeFrame': '6 months before and 6 months after intervention', 'description': 'register based, number of sick leave days'}, {'measure': 'health care contacts', 'timeFrame': '6 months before and 6 months after intervention', 'description': 'register based, number of contacts to OHS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Chronic Pain', 'Health Services', 'Occupational Health'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This cluster randomized waiting-list controlled study will evaluate the effectiveness of pain management group activity organized by the OH on pain intensity and associated disability, and co-occurrence of mental or sleep problem in patients with chronic pain.', 'detailedDescription': 'Pain is very prevalent among the working population causing a considerable amount of work disability days. Pain management group therapy has shown to have a significant effect on chronic pain. However, little is known of the effect of such therapy on work disability. There are especially very few studies prescribing the effectiveness of pain management groups provided by the occupational health service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- chronic pain + increased risk of work disability (based on a screening survey)\n\nExclusion Criteria:\n\n* a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability.\n* participating in another pain group elsewhere.\n* in the middle of a major life crises such as divorce.'}, 'identificationModule': {'nctId': 'NCT02967705', 'briefTitle': 'Pain Management Groups in Occupational Health Settings', 'organization': {'class': 'OTHER', 'fullName': 'Finnish Institute of Occupational Health'}, 'officialTitle': 'Study on Pain Management Groups in Occupational Health Settings', 'orgStudyIdInfo': {'id': '115395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain management group', 'description': '6 + 1 meetings 2 hours each', 'interventionNames': ['Behavioral: Pain management group']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Waiting list - will receive treatment as usual'}], 'interventions': [{'name': 'Pain management group', 'type': 'BEHAVIORAL', 'description': 'Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.', 'armGroupLabels': ['Pain management group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Helena Miranda, Dr.Med.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki City OHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute of Occupational Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Work Environment Fund', 'class': 'OTHER'}, {'name': 'Työterveys Helsinki (Helsinki city occupational health service)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project coordinator', 'investigatorFullName': 'Helena Miranda', 'investigatorAffiliation': 'Finnish Institute of Occupational Health'}}}}