- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271004
Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache (PTRHBCOP-CGH)
Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
This 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.
The 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.
Gaze Direction Recognition Exercise (GDRE) Procedure:
During 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.
An 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.
Primary 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33511
- Faculty of physical therapy kfs university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of head or neck injury or surgery
- Musculoskeletal disorders
- Neurological diseases or disorders
- Metabolic syndromes
- Hypertension or hypotension
- Vestibular disorders
- Inner ear inflammation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Proprioceptive
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. 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. |
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. |
|
Active Comparator: Control Group
Participants 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache frequency (attacks per month)
Time Frame: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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Headache duration (hours per attack)
Time Frame: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Center of Pressure (COP) path length (cm)
Time Frame: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders
- Headache Disorders, Secondary
- Post-Traumatic Headache
- Musculoskeletal and Neural Physiological Phenomena
- Physiological Phenomena
- Nervous System Physiological Phenomena
- Sensation
- Vestibulocochlear Physiological Phenomena
- Proprioception
Other Study ID Numbers
- P.T.REC/012/003409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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