Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache
PTRHBCOP-CGH
1 other identifier
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedFirst Submitted
Initial submission to the registry
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
December 8, 2025
CompletedDecember 8, 2025
November 1, 2025
1.1 years
November 25, 2025
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Headache frequency (attacks per month)
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.
Baseline and after 8 weeks of intervention
Headache duration (hours per attack)
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.
Baseline and after 8 weeks of intervention
Secondary Outcomes (1)
Center of Pressure (COP) path length (cm)
Baseline and after 8 weeks of intervention
Study Arms (2)
Proprioceptive
EXPERIMENTALParticipants 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. 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. Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes.
Control Group
ACTIVE COMPARATORParticipants in the control group received a standardized physiotherapy program three times per week for eight weeks. Each 60-minute session included: 20 minutes of moist heat applied to the neck and shoulder region, 20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width, 5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions. This program represented the conventional physiotherapy regimen for cervicogenic headache management.
Interventions
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. Training was administered three times per week for eight weeks, each session lasting approximately 60 minutes. Would 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.
20 minutes of moist heat applied to the neck and shoulder region, 20 minutes of transcutaneous electrical nerve stimulation (TENS) at 50 Hz and 100 µs pulse width, 5 minutes of continuous-mode ultrasound therapy (1-1.5 W/cm²) to the cervical muscles, and A series of therapeutic exercises to improve cervical mobility, posture correction, and neck-muscle strength through isometric contractions.
Eligibility Criteria
You may qualify if:
- Physician-diagnosed cervicogenic headache (CGH) according to current diagnostic criteria
- Age 35 to 49 years
- Unilateral pain originating in the neck and radiating to the frontotemporal region
- Pain aggravated by neck movements
- Restricted cervical range of motion
- Joint tenderness in at least one upper cervical joint (C1-C3)
- Headache frequency of at least one episode per month for the past year
You may not qualify if:
- History of head or neck injury or surgery
- Musculoskeletal disorders
- Neurological diseases or disorders
- Metabolic syndromes
- Hypertension or hypotension
- Vestibular disorders
- Inner ear inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hungarian University of Sports Sciencelead
- Cairo Universitycollaborator
Study Sites (1)
Faculty of physical therapy kfs university
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt
Related Publications (1)
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.
PMID: 22645685BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Type: Single (Outcomes Assessor) Roles Masked: Outcomes Assessor Participant Masked: No Care Provider Masked: No Investigator Masked: No Outcomes Assessor Masked: Yes
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 25, 2025
First Posted
December 8, 2025
Study Start
July 3, 2024
Primary Completion
August 15, 2025
Study Completion
September 20, 2025
Last Updated
December 8, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be available beginning 6 months after publication of the main results and remain accessible for 3 years thereafter.
- Access Criteria
- 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.
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.