Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04302935
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain & Expert: Global Pain-assessment: a Prospective Registry
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of a global pain-assessment (i.e. practical use)', 'timeFrame': 'at the time of the assessment: one day (cross-sectional)'}], 'secondaryOutcomes': [{'measure': 'norm values for chronic pain patients on all aspects of the global pain-assessment will be reported (i.e. descriptives)', 'timeFrame': 'at the time of the assessment: one day (cross-sectional)', 'description': 'Reporting of norm values on the different aspects of the ICF framework in patients with chronic pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Full assessment of chronic pain patients based on the ICF-model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic pain for at least 3 months\n* Age =\\> 18 years\n* Patient has been informed of the study procedures and has given written informed consent\n\nExclusion Criteria:\n\n* Healthy patients or patients with acute pain.\n* Addiction to drugs, alcohol (\\>5 units per day)\n* Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04302935', 'briefTitle': 'Pain & Expert: Global Pain-assessment: a Prospective Registry', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Pain & Expert: Global Pain-assessment: a Prospective Registry', 'orgStudyIdInfo': {'id': 'P&E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic pain patients', 'interventionNames': ['Other: Global pain-assessment']}], 'interventions': [{'name': 'Global pain-assessment', 'type': 'OTHER', 'description': 'Global pain-assessment, based on the ICF framework', 'armGroupLabels': ['chronic pain patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maarten Moens', 'role': 'CONTACT'}, {'name': 'Lisa Goudman', 'role': 'CONTACT'}], 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'Maarten Moens, prof. dr.', 'role': 'CONTACT', 'email': 'maarten.moens@uzbrussel.be', 'phone': '+32 2 477 55 14'}, {'name': 'Lisa Goudman, MSc.', 'role': 'CONTACT', 'phone': '+32 2 477 55 14'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moens Maarten', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Moens Maarten', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}