Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-07 @ 10:46 PM
Study NCT ID:
NCT02697656
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Individual Placement and Support in Chronic Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-01', 'size': 510526, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-08T09:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Competitive employment', 'timeFrame': 'At 12-months follow-up', 'description': 'Hours/days/weeks worked in competitive employment the last 12 months'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '6 and 12 months follow-up', 'description': 'EQ5D termometer'}, {'measure': 'Pain-related disability', 'timeFrame': '6 and 12 months follow-up', 'description': 'Oswestry, modified to chronic pain patients'}, {'measure': 'Pain intensity', 'timeFrame': '6 and 12 months follow-up', 'description': 'Numeric Rating Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '23161326', 'type': 'BACKGROUND', 'citation': 'Bond GR, Drake RE. Making the case for IPS supported employment. Adm Policy Ment Health. 2014 Jan;41(1):69-73. doi: 10.1007/s10488-012-0444-6.'}, {'pmid': '18407876', 'type': 'BACKGROUND', 'citation': 'Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.'}, {'pmid': '35234931', 'type': 'DERIVED', 'citation': 'Sveinsdottir V, Jacobsen HB, Ljosaa TM, Linnemorken LTB, Knutzen T, Ghiasvand R, Reme SE. The Individual Placement and Support (IPS) in Pain Trial: A Randomized Controlled Trial of IPS for Patients with Chronic Pain Conditions. Pain Med. 2022 Sep 30;23(10):1757-1766. doi: 10.1093/pm/pnac032.'}, {'pmid': '29433493', 'type': 'DERIVED', 'citation': 'Linnemorken LTB, Sveinsdottir V, Knutzen T, Rodevand L, Hernaes KH, Reme SE. Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain. BMC Musculoskelet Disord. 2018 Feb 13;19(1):47. doi: 10.1186/s12891-018-1962-5.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/29433493', 'label': 'The Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.', 'detailedDescription': 'Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. IPS represents a relatively new approach to vocational rehabilitation and incorporates following principles: (1) Every person that wants to work, can work given that the person is provided with the appropriate work and environment. (2)The goal is employment in regular, competitive employment. (3) IPS is integrated with treatment. (4) Job search is individualised; based on the participants\' preferences and competence. (5) Work incentives planning is provided; which includes counselling about how work can influence social security and other public benefits. The intention of this benefits counselling is to enable the participant to make informed decisions about work (job starts and changes). (6) The job support is not time-limited. (7) Finally, IPS differs from more traditional employment services in that it does not involve pre-vocational training, often referred to as "train, then place". (8) In IPS job search starts as soon as the client expresses an interest in work. Therefore, IPS follows the principle "place, then train".\n\nThe effectiveness of IPS for patients with severe mental illness is well documented. International research shows that IPS is more effective than other types of employment programs for this group of clients. However, the effect of IPS on patients with chronic pain in an outpatient hospital clinic is largely unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the pain clinic and eligible for interdisciplinary treatment\n* Not currently working (long-term sick leave, disability pension or unemployed)\n* Expressed desire to work\n\nExclusion Criteria:\n\n* Living too far away from the pain clinic (outside of Oslo)'}, 'identificationModule': {'nctId': 'NCT02697656', 'acronym': 'IPSinPain', 'briefTitle': 'The Effectiveness of Individual Placement and Support in Chronic Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Assessing the Effectiveness of the Individual Placement and Support Model for Patients With Chronic Pain in an Outpatient Hospital Pain Clinic', 'orgStudyIdInfo': {'id': '2015/14224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual + self-help', 'description': 'Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice.', 'interventionNames': ['Behavioral: Self-help', 'Behavioral: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment as usual + IPS', 'description': 'Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic.', 'interventionNames': ['Behavioral: IPS', 'Behavioral: Treatment as usual']}], 'interventions': [{'name': 'IPS', 'type': 'BEHAVIORAL', 'description': 'Individualized job support provided by an employment specialist', 'armGroupLabels': ['Treatment as usual + IPS']}, {'name': 'Self-help', 'type': 'BEHAVIORAL', 'description': 'Self-help resources on obtaining employment and coping with chronic pain', 'armGroupLabels': ['Treatment as usual + self-help']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.', 'armGroupLabels': ['Treatment as usual + IPS', 'Treatment as usual + self-help']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Silje Endresen Reme', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Silje E Reme, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Directorate of Health', 'class': 'OTHER_GOV'}, {'name': 'Norwegian Labour and Welfare Administration', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Silje Endresen Reme', 'investigatorAffiliation': 'Oslo University Hospital'}}}}