Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-05 @ 6:36 AM
Study NCT ID:
NCT02460003
Status:
UNKNOWN
Last Update Posted:
2015-07-31
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy Program for Cluster Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cluster Headache']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.agclinic.es', 'label': 'AGClinic Advanced Physiotherapy'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.', 'detailedDescription': 'Previous studies have shown positive effects of physical therapy in patients with primary headache.\n\nHowever, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cluster headache diagnosed\n\nExclusion Criteria:\n\n* Other types of headaches.\n* Neurostimulator implanted.\n* Other chronic pain processes'}, 'identificationModule': {'nctId': 'NCT02460003', 'acronym': 'PhyCH', 'briefTitle': 'Physiotherapy Program for Cluster Headache', 'organization': {'class': 'OTHER', 'fullName': 'AG Clinic'}, 'officialTitle': 'Effectiveness of Physiotherapy Program in Patients With Cluster Headache', 'orgStudyIdInfo': {'id': 'CH-Physiotherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy program', 'description': 'Physiotherapy program and usual drugs', 'interventionNames': ['Behavioral: Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home exercise program', 'description': 'Home exercise program and usual drugs', 'interventionNames': ['Other: Home exercise program']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'BEHAVIORAL', 'otherNames': ['Manual Therapy, Physical Therapy'], 'description': 'A program of physiotherapy including manual therapy, exercise, pain education.', 'armGroupLabels': ['Physiotherapy program']}, {'name': 'Home exercise program', 'type': 'OTHER', 'otherNames': ['Therapeutic exercise'], 'description': 'Home exercise program', 'armGroupLabels': ['Home exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'AGClinic', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Alfonso Gil-MartÃnez, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario La Paz. AGClinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AG Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}