Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 6:49 PM
Study NCT ID:
NCT06991504
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cervical Stabilization Training in Individuals With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Craniovertebral Angle', 'timeFrame': 'up to 4 weeks', 'description': 'Craniovertebral Angle measuremnt'}, {'measure': 'Tragus- Wall Distance', 'timeFrame': 'up to 4 weeks', 'description': 'Tragus- Wall Distance is is used to measure cervical anterior tilt.'}, {'measure': 'Cervical Range of Motion Measurement (C-ROM)', 'timeFrame': 'up to 4 weeks', 'description': 'Cervical Range of Motion Measurement (C-ROM) is used to measure range of motion.'}, {'measure': 'Craniocervical Flexion Test', 'timeFrame': 'up to 4 weeks', 'description': 'Craniocervical Flexion Test measures the endurance of the deep cervical flexor muscles.'}, {'measure': 'Cervical Joint Position Sensation Assessment', 'timeFrame': 'up to 4 weeks', 'description': 'The Cervical Joint Position Sensation Assessment is an easy standardized measurement and provides a sensory assessment.'}, {'measure': 'Mini Balance Assessment Systems Test', 'timeFrame': 'up to 4 weeks', 'description': 'The Mini Balance Assessment Systems Test is an easy-to-administer and reliable balance assessment.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale - VAS', 'timeFrame': 'up to 4 weeks', 'description': 'Visual Analogue Scale - VAS assesses pain.'}, {'measure': 'Pain Catastrophization Scale', 'timeFrame': 'up to 4 weeks', 'description': 'Pain Catastrophization Scale assesses pain.'}, {'measure': 'Migraine-related disability assessment scale', 'timeFrame': 'up to 4 weeks', 'description': 'Migraine-related disability assessment scale is a method applied in migraine patients and evaluates the level of disability.'}, {'measure': 'Neck Disability Questionnaire', 'timeFrame': 'up to 4 weeks', 'description': 'Neck Disability Questionnaire assesses neck disability.'}, {'measure': 'Beck depression questionnaire', 'timeFrame': 'up to 4 weeks', 'description': 'Beck depression questionnaire assesses emotional state'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Studies examining stabilization training and cervical muscle endurance generally focused on headache as the main topic and did not focus on migraine. Studies examining the effects of vestibular training focused on the effects on vestibular migraine and did not address migraine holistically. Although the effects of vestibular rehabilitation and cervical stabilisation training on balance, cervical muscle endurance and joint position error in individuals with migraine have been examined separately, no study has been found in which all these topics were combined. Based on these reasons, this study aims to investigate the effects of two trainings on cervical muscle strength, normal range of motion, anterior tilt, joint position error, deep muscle endurance and balance in individuals with migraine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old\n* Being diagnosed with migraine by a neurologist according to the International Headache Society Criteria\n* Complaining of headache at least once a week or more in the last year\n\nExclusion Criteria:\n\n* History of other diseases or operations in the cervical region\n* Having any neurological or orthopedic disease\n* Passing a serious head and/or neck trauma\n* Participating in a physiotherapy program for head and neck pain in the last 12 months\n* Having a visual impairment'}, 'identificationModule': {'nctId': 'NCT06991504', 'briefTitle': 'The Effect of Cervical Stabilization Training in Individuals With Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'The Effect of Cervical Stabilization Training and Vestibular Training on Cervical Region and Balance in Individuals With Migraine', 'orgStudyIdInfo': {'id': 'BEUN-MIGREN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STABILIZATION GROUP', 'description': 'Group receiving cervical stabilization exercise', 'interventionNames': ['Behavioral: Cervical Stabilization Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Vestıbular rehabilitation', 'description': 'Group receiving vestibular rehabilitation', 'interventionNames': ['Behavioral: vestibular exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Group receiving classical neck exercise', 'interventionNames': ['Behavioral: Classic cervical/ neck exercises']}], 'interventions': [{'name': 'Cervical Stabilization Exercises', 'type': 'BEHAVIORAL', 'description': 'The main goal of this training is to increase the strength and endurance of the deep cervical flexor and extensor muscles.', 'armGroupLabels': ['STABILIZATION GROUP']}, {'name': 'vestibular exercises', 'type': 'BEHAVIORAL', 'description': 'Vestibular exercises are a training used in individuals with migraine to ensure balance and coordination.', 'armGroupLabels': ['Vestıbular rehabilitation']}, {'name': 'Classic cervical/ neck exercises', 'type': 'BEHAVIORAL', 'description': 'Classic cervical neck exercises including stretching and strengthening', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03000', 'city': 'Merkez', 'state': 'Zonguldak Province', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Bulent Ecevit University'}], 'overallOfficials': [{'name': 'Arzucan Toksal Uçar, PT. PhD:', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zonguldak Bulent Ecevit University'}, {'name': 'Gizem Alarçin, PT.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zonguldak Bulent Ecevit University'}, {'name': 'Esra Acıman Demirel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zonguldak Bulent Ecevit University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD.', 'investigatorFullName': 'ARZUCAN TOKSAL UÇAR', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}