Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache

NCT ID: NCT07271004

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2025-09-20

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.

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.

Conditions

Cervicogenic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Proprioception

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

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.

Interventions

Proprioception

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.

Intervention Type: OTHER

Conventional physical therapy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Hungarian University of Sports Science

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdelaziz Emam

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy kfs university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 22645685 (View on PubMed)

Other Identifiers

P.T.REC/012/003409

Identifier Type: -

Identifier Source: org_study_id