NCT07271004

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 25, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Cervicogenic Headache;Headache BurdenPostural BalanceProprioceptionEye Movements

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

EXPERIMENTAL

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.

Other: Proprioception

Control Group

ACTIVE COMPARATOR

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.

Other: Conventional physical therapy

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.

Proprioceptive

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.

Control Group

Eligibility Criteria

Age35 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Faculty of physical therapy kfs university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

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

Post-Traumatic Headache

Interventions

Proprioception

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Model Details: 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.
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

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.

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.

Locations