Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 9:19 PM
Study NCT ID:
NCT01835704
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-economic Evaulation of Interventional Pain Mangement
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': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-16', 'studyFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality Adjusted Life gained', 'timeFrame': '1 year', 'description': 'QALY is calculated from the EQ-5D value using the TTO-validated UK value set accoring to ordinary health-economic evaluations.'}], 'secondaryOutcomes': [{'measure': 'Cost per QALY gained', 'timeFrame': '1 year', 'description': 'The cost per QALY gained is calculated according to normal health-economic evaluation models.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '34793647', 'type': 'DERIVED', 'citation': 'Hambraeus J, Pulkki-Brannstrom AM, Lindholm L. Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain. Pain Physician. 2021 Dec;24(8):E1205-E1218.'}]}, 'descriptionModule': {'briefSummary': 'To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pain of more then 6 months duration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01835704', 'briefTitle': 'Health-economic Evaulation of Interventional Pain Mangement', 'organization': {'class': 'OTHER', 'fullName': 'Eques Indolor AB'}, 'officialTitle': 'Health-economic Evaluation of Interventional Pain Management Among Patients With Chronic Pain', 'orgStudyIdInfo': {'id': 'SE-Dnr-2012-446-31M-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic pain associated to facet-joints', 'description': 'Patients where the pain can be localized to the facet joints.', 'interventionNames': ['Other: Radio-frequency dennervation of facet joint']}, {'label': 'Chronic pain of other origin', 'description': 'Patients with pain that can not be localized to facet joints.', 'interventionNames': ['Other: Diagnostic nerve-blocks performed under direct x-ray vision']}], 'interventions': [{'name': 'Radio-frequency dennervation of facet joint', 'type': 'OTHER', 'armGroupLabels': ['Chronic pain associated to facet-joints']}, {'name': 'Diagnostic nerve-blocks performed under direct x-ray vision', 'type': 'OTHER', 'armGroupLabels': ['Chronic pain of other origin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90325', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Smärtkliniken i Umeå', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Johan Hambraeus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eques Indolor AB', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}