Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07271004
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'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': 'D011434', 'term': 'Proprioception'}], 'ancestors': [{'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Type: Single (Outcomes Assessor)\n\nRoles Masked: Outcomes Assessor\n\nParticipant Masked: No\n\nCare Provider Masked: No\n\nInvestigator Masked: No\n\nOutcomes Assessor Masked: Yes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly allocated into two parallel groups with equal allocation (1:1 ratio). The control group received a standard physiotherapy program including heat therapy, TENS, ultrasound, and cervical mobility and strengthening exercises. The experimental group received the same physiotherapy program plus a 10-minute proprioceptive gaze direction recognition (GDR) training task during each session. Both groups underwent three sessions per week for eight weeks. The design allowed for comparison of outcomes between groups receiving standard therapy alone versus those receiving standard therapy combined with proprioceptive training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache frequency (attacks per month)', 'timeFrame': 'Baseline and after 8 weeks of intervention', 'description': 'Change in the number of cervicogenic headache attacks per month, as recorded by participants in a headache diary. Headache frequency was averaged over four weeks at baseline and again at post-intervention. Lower values indicate improvement.'}, {'measure': 'Headache duration (hours per attack)', 'timeFrame': 'Baseline and after 8 weeks of intervention', 'description': 'Change in the mean duration of headache episodes, expressed in hours per attack, recorded from participant headache diaries. Duration was averaged across all episodes within each 4-week period at baseline and post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Center of Pressure (COP) path length (cm)', 'timeFrame': 'Baseline and after 8 weeks of intervention', 'description': 'Change in total center-of-pressure path length measured during quiet standing using the HUMAC Balance System (CSMi, USA). Shorter path length reflects improved postural stability and sensorimotor control.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervicogenic Headache;', 'Headache Burden', 'Postural Balance', 'Proprioception', 'Eye Movements'], 'conditions': ['Cervicogenic Headache']}, 'referencesModule': {'references': [{'pmid': '22645685', 'type': 'BACKGROUND', 'citation': 'Nobusako S, Matsuo A, Morioka S. Effectiveness of the gaze direction recognition task for chronic neck pain and cervical range of motion: a randomized controlled pilot study. Rehabil Res Pract. 2012;2012:570387. doi: 10.1155/2012/570387. Epub 2012 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Cervicogenic headache (CGH) is a secondary headache originating from dysfunction in the cervical spine and is associated with impaired sensorimotor control and postural instability. This randomized, assessor-blinded, parallel-group clinical trial aims to investigate whether adding gaze direction recognition (GDR)-based proprioceptive training to a conventional physiotherapy program can reduce headache burden and improve postural balance in individuals with CGH. Participants are randomly allocated to receive either standard physiotherapy or standard physiotherapy plus GDR training for eight weeks. Primary outcomes include headache frequency, headache duration, and center-of-pressure (COP) path length during quiet standing. The study is conducted in accordance with ethical guidelines and was approved by the relevant institutional review board.', 'detailedDescription': "Cervicogenic headache (CGH) is a secondary headache arising from disorders of the cervical spine and related structures. Individuals with CGH commonly present with impaired cervical proprioception and altered postural control. Sensorimotor retraining strategies, such as gaze direction recognition (GDR), have been used in chronic neck pain populations to target proprioceptive deficits; however, their application in CGH has not been comprehensively investigated.\n\nThis randomized, controlled, assessor-blinded clinical trial is designed to evaluate whether adding proprioceptive GDR training to a standardized physiotherapy program results in greater reductions in headache burden and improvements in postural balance compared with physiotherapy alone. Thirty-eight participants meeting ICHD-3 diagnostic criteria for CGH are randomly assigned in a 1:1 ratio to a control group receiving standard physiotherapy or to a treatment group receiving standard physiotherapy plus GDR training. The intervention is delivered three times per week for eight weeks.\n\nThe standardized physiotherapy program includes thermotherapy, transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, and therapeutic exercises for cervical mobility, posture correction, and isometric strengthening. The treatment group receives the same program with the addition of a structured GDR proprioceptive task.\n\nGaze Direction Recognition Exercise (GDRE) Procedure:\n\nDuring the GDRE, the therapist sits in a chair positioned 0.75 m behind the center of a wooden table (1.8 × 0.4 × 0.76 m). Six wooden blocks, numbered 1 to 6 from left to right, are placed along the table edge nearest the therapist, spaced 0.31 m apart. Patients sit in a chair behind the therapist with a clear view of the numbered blocks.\n\nAn assistant signals the start of each trial, at which point the therapist randomly directs his gaze and head toward one of the blocks. As patients observe the therapist's neck rotation from behind, they rotate their own head in the same direction and verbally report the number of the block they believe the therapist is looking at. Patients are instructed to avoid moving other body parts during head rotation. No accuracy feedback is provided to the patient. The assistant records both reaction time and accuracy for each response. Each GDRE session consists of 30 trials and lasts approximately 10 minutes.\n\nPrimary outcomes include headache frequency (attacks per month), headache duration (hours per attack), and center-of-pressure (COP) path length during quiet standing, measured at baseline and after eight weeks of intervention. The study protocol was reviewed and approved by the Faculty of Physical Therapy Ethics Committee, Cairo University, and all participants provide written informed consent before enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed cervicogenic headache (CGH) according to current diagnostic criteria\n* Age 35 to 49 years\n* Unilateral pain originating in the neck and radiating to the frontotemporal region\n* Pain aggravated by neck movements\n* Restricted cervical range of motion\n* Joint tenderness in at least one upper cervical joint (C1-C3)\n* Headache frequency of at least one episode per month for the past year\n\nExclusion Criteria:\n\n* History of head or neck injury or surgery\n* Musculoskeletal disorders\n* Neurological diseases or disorders\n* Metabolic syndromes\n* Hypertension or hypotension\n* Vestibular disorders\n* Inner ear inflammation'}, 'identificationModule': {'nctId': 'NCT07271004', 'acronym': 'PTRHBCOP-CGH', 'briefTitle': 'Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Hungarian University of Sports Science'}, 'officialTitle': 'Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proprioceptive', 'description': "Participants in the experimental group received the same standard physiotherapy program as the control group, with the addition of a 10-minute proprioceptive Gaze Direction Recognition (GDR) training task during each session.\n\nThe GDR training involved observing another person's head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions.\n\nTraining was administered three times per week for eight weeks, each session lasting approximately 60 minutes.", 'interventionNames': ['Other: Proprioception']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in the control group received a standardized physiotherapy program three times per week for eight weeks. Each 60-minute session included:\n\n20 minutes of moist heat applied to the neck and shoulder region,\n\n20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width,\n\n5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and\n\nA series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions.\n\nThis program represented the conventional physiotherapy regimen for cervicogenic headache management.', 'interventionNames': ['Other: Conventional physical therapy']}], 'interventions': [{'name': 'Proprioception', 'type': 'OTHER', 'description': 'The GDR training involved observing another person\'s head and neck rotations from behind and identifying the direction of gaze, requiring motor imagery and visuospatial judgment to activate cervical sensorimotor pathways. Task difficulty was progressively increased across sessions.\n\nTraining was administered three times per week for eight weeks, each session lasting approximately 60 minutes.\n\nWould you like me to now write the Intervention Description sections (the short entries that go under "Intervention Name," "Type," and "Description" linked to each arm)? Those are the next fields after the Arm descriptions.', 'armGroupLabels': ['Proprioceptive']}, {'name': 'Conventional physical therapy', 'type': 'OTHER', 'description': '20 minutes of moist heat applied to the neck and shoulder region,\n\n20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width,\n\n5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and\n\nA series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'country': 'Egypt', 'facility': 'Faculty of physical therapy kfs university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available beginning 6 months after publication of the main results and remain accessible for 3 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared dataset will include variables related to baseline demographics, group allocation, headache frequency, headache duration, and center-of-pressure (COP) path length outcomes. Data will be provided in a coded format without any information that could identify individual participants. Access will be granted to qualified researchers for academic and non-commercial purposes following approval of a methodologically sound proposal and signing of a data access agreement.', 'accessCriteria': 'Qualified researchers may request access to the de-identified dataset for the purpose of academic, non-commercial research related to cervicogenic headache, physiotherapy, or sensorimotor training. Requests should include a brief study proposal outlining objectives, methods, and data requirements. Access will be granted following review and approval by the principal investigator and after execution of a data access agreement ensuring participant confidentiality and compliance with ethical data use standards.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hungarian University of Sports Science', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Abdelaziz Emam', 'investigatorAffiliation': 'Hungarian University of Sports Science'}}}}