Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT03426800
Status:
TERMINATED
Last Update Posted:
2018-11-28
First Post:
2018-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture - a Treatment for Children With Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Limited numbers of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with headache', 'timeFrame': '30 days', 'description': 'Number of days with headache'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Training', 'Children', 'Effect'], 'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': 'Acupuncture as a treatment for headache in children', 'detailedDescription': 'A randomised controlled study in the effect of acupuncture as a treatment for headache in children.\n\nThe children are randomised for training or for training and acupuncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed by pediatrician-\n* Age-9-17 years\n* Min. headache 8 times within the last month\n\nExclusion Criteria:\n\n* Mentally illness\n* Fear of needles'}, 'identificationModule': {'nctId': 'NCT03426800', 'briefTitle': 'Acupuncture - a Treatment for Children With Headache', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Regionshospital Nordjylland'}, 'officialTitle': 'Acupuncture - a Treatment for Children With Headache', 'orgStudyIdInfo': {'id': 'RHN_DMK_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Migraine_acupuncture and training', 'description': 'Migraine acupuncture and training', 'interventionNames': ['Other: Acupuncture and training']}, {'type': 'EXPERIMENTAL', 'label': 'Migraine training', 'description': 'Migraine training', 'interventionNames': ['Other: Acupuncture and training']}, {'type': 'EXPERIMENTAL', 'label': 'Tension_acupuncture and training', 'description': 'Tension headache acupuncture and training', 'interventionNames': ['Other: Acupuncture and training']}, {'type': 'EXPERIMENTAL', 'label': 'Tension headache training', 'description': 'Tension headache training', 'interventionNames': ['Other: Acupuncture and training']}], 'interventions': [{'name': 'Acupuncture and training', 'type': 'OTHER', 'description': 'Acupuncture twice in the week in 3 weeks combined with training in 6 weeks', 'armGroupLabels': ['Migraine training', 'Migraine_acupuncture and training', 'Tension headache training', 'Tension_acupuncture and training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9800', 'city': 'Hjørring', 'country': 'Denmark', 'facility': 'North Denmark Hospital', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospital Nordjylland', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Dorte Melgaard Kristiansen', 'investigatorAffiliation': 'Regionshospital Nordjylland'}}}}