Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT01155557
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache', 'timeFrame': 'At baseline', 'description': 'Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.'}, {'measure': 'Muscle Capacity', 'timeFrame': 'At baseline', 'description': 'Neck and shoulder muscle function variables:\n\nMVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).'}, {'measure': 'Headache', 'timeFrame': 'After the 10 weeks intervention programme', 'description': 'Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.'}, {'measure': 'Headache', 'timeFrame': 'At 3 months follow up.', 'description': 'Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.'}, {'measure': 'Muscle Capacity', 'timeFrame': 'After the 10 weeks intervention programme', 'description': 'Neck and shoulder muscle function variables:\n\nMVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).'}, {'measure': 'Muscle Capacity', 'timeFrame': 'At 3 months follow up.', 'description': 'Neck and shoulder muscle function variables:\n\nMVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).'}], 'secondaryOutcomes': [{'measure': 'TTS', 'timeFrame': 'At baseline', 'description': 'Total Tenderness Score ( palpation of percranial tenderness).'}, {'measure': 'Physical fitness', 'timeFrame': 'At baseline', 'description': 'Submaximal ergometer bicycle test'}, {'measure': 'TTS', 'timeFrame': 'After the 10 weeks intervention programme', 'description': 'Total Tenderness Score ( palpation of pericranial tenderness).'}, {'measure': 'TTS', 'timeFrame': 'At 3 months follow up.', 'description': 'Total Tenderness Score ( palpation of pericranial tenderness).'}, {'measure': 'Physical fitness', 'timeFrame': 'After the 10 weeks intervention programme', 'description': 'Submaximal ergometer bicycle test'}, {'measure': 'Physical fitness', 'timeFrame': 'At 3 months follow up.', 'description': 'Submaximal ergometer bicycle test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tension-Type Headache', 'Strength Capacity', 'Neck and Shoulder'], 'conditions': ['Tension-Type Headache']}, 'descriptionModule': {'briefSummary': 'This study aims at examining muscle strength capacity in neck and shoulder muscles in children and adolescents with and without tension-type headache, and furthermore examining the effect of a 10 week specific strength training programme for neck and shoulder muscles compared to a multi-disciplinary approach in 10 weeks.', 'detailedDescription': "Frequent and chronic tension type headache are the most frequent pain illnesses in children with a prevalence of 0.5-7,6%. Frequent or daily headache leads to constraints in the child's life in relation to school and social activities.\n\nThe underlying pathophysiological mechanisms are not yet fully examined. In several studies in adults and in children it is found that the shoulder muscles are tense and tender, but it is not known whether this phenomenon is primary or secondary to tension-type headache. A decrease in muscle capacity is furthermore found in studies. We therefore aim at examining parameters for muscle function in order to compare the differences between children with and without headache, and at examining the effect of a 10 week progressive specific strength training programme on headache compared to an in time comparable multidisciplinary intervention based on lifestyle counseling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary tension-type headache with no more than one episode of migraine pr. month\n\nExclusion Criteria:\n\n* post-trauma headache\n* co-morbidity'}, 'identificationModule': {'nctId': 'NCT01155557', 'briefTitle': 'The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Strength Capacity of Neck and Shoulder Muscles in Children and Adolescents 9-17 Years With Tension Type Headache and the Effect of Specific Strength-Training on Tension-Type Headache', 'orgStudyIdInfo': {'id': 'H-3-2009-081'}, 'secondaryIdInfos': [{'id': '2009-41-3697', 'type': 'OTHER', 'domain': 'The Danish Data Council, Datatilsynet'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Specific Strength Training', 'description': '10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.', 'interventionNames': ['Device: Specific Strength Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle Counseling', 'description': '10 weeks of counseling by nurse and physiotherapist in lifestyle changes.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}], 'interventions': [{'name': 'Specific Strength Training', 'type': 'DEVICE', 'otherNames': ['A'], 'description': '10 weeks of progressive specific strength training for neck and shoulder muscles.', 'armGroupLabels': ['Specific Strength Training']}, {'name': 'Lifestyle Counseling', 'type': 'BEHAVIORAL', 'otherNames': ['B'], 'description': '10 weeks of counseling by nurse and physiotherapist in lifestyle changes.', 'armGroupLabels': ['Lifestyle Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Copenhagen', 'state': 'Herlev', 'country': 'Denmark', 'facility': 'Birte Tornøe', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Birte Tornøe, PhD,MSc,PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University Hospitals Centre for Nursing and Care Research, Copenhagen', 'class': 'UNKNOWN'}, {'name': 'The Beckett-Fond', 'class': 'UNKNOWN'}, {'name': 'The Fond of Jørgen Holm and Elisa F. Hansen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MSc, PT', 'investigatorFullName': 'Birte Tornoe', 'investigatorAffiliation': 'Herlev Hospital'}}}}