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:
Hungarian University of Sports Science
Organization:
Study Overview
Official Title:
Proprioceptive Training Reduces Headache Burden and Center of Pressure Path Length in Patients With Cervicogenic Headache: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTRHBCOP-CGH
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: