Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-27 @ 1:13 AM
Study NCT ID:
NCT03503734
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2018-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Care for Migraine and Chronic Tension-type Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache frequency', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Headache days/month'}], 'secondaryOutcomes': [{'measure': 'Headache frequency', 'timeFrame': '6 months after treatment end', 'description': 'Headache days/month'}, {'measure': 'Pain intensity', 'timeFrame': 'Treatment end, an average of 5 months', 'description': '100mm visual analog scale'}, {'measure': 'Pain intensity', 'timeFrame': '6 months after treatment end', 'description': '100mm visual analog scale'}, {'measure': 'Pain bothersomeness', 'timeFrame': 'Treatment end, an average of 5 months', 'description': '100mm visual analog scale'}, {'measure': 'Pain bothersomeness', 'timeFrame': '6 months after treatment end', 'description': '100mm visual analog scale'}, {'measure': 'Pain perception', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Pain Perception Scale'}, {'measure': 'Pain perception', 'timeFrame': '6 months after treatment end', 'description': 'Pain Perception Scale'}, {'measure': 'Quality of life', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'SF-12'}, {'measure': 'Quality of life', 'timeFrame': '6 months after treatment end', 'description': 'SF-12'}, {'measure': 'Headache Disability', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Headache Disability Inventory (HDI)'}, {'measure': 'Headache Disability', 'timeFrame': '6 months after treatment end', 'description': 'Headache Disability Inventory (HDI)'}, {'measure': 'Anxiety/Depression Scale', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Anxiety/Depression Scale', 'timeFrame': '6 months after treatment end', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Function', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Patient-specific Functional Scale (PSFS)'}, {'measure': 'Function', 'timeFrame': '6 months after treatment end', 'description': 'Patient-specific Functional Scale (PSFS)'}, {'measure': 'Self-Efficacy', 'timeFrame': 'Treatment end, an average of 5 months', 'description': 'Pain Self-Efficacy Questionnaire (FESS)'}, {'measure': 'Self-Efficacy', 'timeFrame': '6 months after treatment end', 'description': 'Pain Self-Efficacy Questionnaire (FESS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Headache']}, 'descriptionModule': {'briefSummary': 'Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.\n\n158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.', 'detailedDescription': 'Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.\n\n158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients insured with Barmer GEK or Techniker Krankenkasse, large German statutory health insurances, and diagnosed with migraine and/or tension-type headaches were eligible for integrated care. All patients, who were over 18 years old with headache at least five days per month for at least 6 months and current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache were suited to be involved in the observational study. Patients were referred by specialists or general practitioners to the Department of Internal and Integrative Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nheadache at least five days per month for at least 6 months current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache\n\nExclusion Criteria: None.'}, 'identificationModule': {'nctId': 'NCT03503734', 'acronym': 'IV', 'briefTitle': 'Integrated Care for Migraine and Chronic Tension-type Headaches', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Integrated Care for Migraine and Chronic Tension-type Headaches', 'orgStudyIdInfo': {'id': '11-4749'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Integrated headache care', 'description': "The treatment can be realized on an inpatient, outpatient and/or day care basis, according to the severity level of illness and comorbidities.\n\nThe inpatient treatment takes place at the Department of Internal and Integrative Medicine. The stay is slated for 14 days.\n\nDay care can follow the inpatient stay or can be applied as sole therapy. As part of the standard care provided at the Department for Internal and Integrative Medicine, it occurs at a semi-residential clinic for 6 hours once a week over a total of 10 weeks.\n\nThe outpatient treatment is delivered in the Department's outpatient ward. It consists of acupuncture, cupping, hydrotherapy and massages as well as nutritional counseling. The patients can additionally be offered one-to-one mind-body-medicine interventions.", 'interventionNames': ['Behavioral: Integrated headache care']}], 'interventions': [{'name': 'Integrated headache care', 'type': 'BEHAVIORAL', 'description': "The treatment can be realized on an inpatient, outpatient and/or day care basis, according to the severity level of illness and comorbidities.\n\nThe inpatient treatment takes place at the Department of Internal and Integrative Medicine. The stay is slated for 14 days.\n\nDay care can follow the inpatient stay or can be applied as sole therapy. As part of the standard care provided at the Department for Internal and Integrative Medicine, it occurs at a semi-residential clinic for 6 hours once a week over a total of 10 weeks.\n\nThe outpatient treatment is delivered in the Department's outpatient ward. It consists of acupuncture, cupping, hydrotherapy and massages as well as nutritional counseling. The patients can additionally be offered one-to-one mind-body-medicine interventions.", 'armGroupLabels': ['Integrated headache care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Holger Cramer', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}