Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-01 @ 11:36 PM
Study NCT ID:
NCT04657159
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15611}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '1 year', 'description': 'EQ-5D index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is to evaluate interventional pain management. This is done in three steps:\n\n1. To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.\n2. To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.\n3. To calculate cost-effectiveness of PRP during the period 2017-2019, after the changed guidelines for PRP in Sweden.\n\nThe two last steps are to provide a background to the results of IPM, and to see if the results in the subgroup of matched controls of PRP-patients differ from the results from the whole population.', 'detailedDescription': "Chronic pain is one of the major health problems globally, according to the WHO 'global burden of disease' studies. Previously, the investigators have performed a study on a feasible approach to be able to treat zygapophyseal joint pain in the thoracic region, similar to the established methods for treatment in the lumbar and cervical regions which have been published. The study showed that there was a significant improvement in health related quality of life (HRQoL) after treatment, and that there were no difference in the results depending on if it was the cervical, thoracic or lumbar region that was treated. The study had ethical approval (Dnr 2012-446-31M) and is registered here at clinicaltrials.gov.\n\nAnother study explored the health economic aspects of interventional pain management (IPM). The investigators aimed to do this in comparison with pain rehabilitation programs, and therefore further ethical approval was searched and gained (2012-446-31M, 2017-542-32, 2018- 507-32) An health-economic evaluation of only IPM was performed showing that patients after treatment of diagnosed pain-focuses in zygapophyseal joint pain not only improve their HRQoL but they also reduce their medication, reduced their health-care consumption and gained in ability to work. The cost per quality adjusted life years gained was below the threshold for cost-effective health-care according to the threshold-levels defined by the national Board of Health and Welfare in Sweden. But the investigators need a larger population to select from in order to get matched controls among patients that have been through pain rehabilitation programs.\n\nThis study therefore aims to explore the national register of pain rehabilitation both in order to find matched controls and in order to make a cost-effectiveness study of pain rehabilitation program as it is performed in Sweden."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have been treated with pain rehabilitation programs and that have been registered prospectively in the national register for pain rehabilitation in Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBeen through pain rehabilitation program\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04657159', 'briefTitle': 'Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Eques Indolor AB'}, 'officialTitle': 'Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation', 'orgStudyIdInfo': {'id': 'IPM-PRP2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2010-2016', 'description': 'Patients treated 2010-2016', 'interventionNames': ['Other: Pain rehabilitation program']}, {'label': '2017-2019', 'description': 'Patients treated 2017-2019', 'interventionNames': ['Other: Pain rehabilitation program']}], 'interventions': [{'name': 'Pain rehabilitation program', 'type': 'OTHER', 'description': 'Effect on health related quality of life och health-care consumption after rehabilitation', 'armGroupLabels': ['2010-2016', '2017-2019']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Department of Epidemiology and Global Health Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '18695', 'city': 'Vallentuna', 'country': 'Sweden', 'facility': 'Smärtkliniken Eques Indolor', 'geoPoint': {'lat': 59.53436, 'lon': 18.07758}}], 'overallOfficials': [{'name': 'Lars Lindholm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PhD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing IPD is restricted by law in Sweden and any sharing needs a specific approval from ethics board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eques Indolor AB', 'class': 'OTHER'}, 'collaborators': [{'name': 'Umeå University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}