- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518108
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache: A Randomized Controlled Trial
This study aims to investigate the effect of specific exercise programs on individuals suffering from cervicogenic headaches, a type of headache originating from neck problems. While traditional physiotherapy is the standard approach, this research examines whether the addition of specific "fascia-focused" exercises or "breathing exercises" provides improved relief.
Fascia is a thin, protective membrane layer surrounding every muscle and organ in the body. In this study, participants will be divided into three groups. All participants will receive standard neck exercises and posture training. One group will perform dynamic exercises targeting the body's connective tissue (fascia) to improve flexibility and coordination. Another group will practice specific breathing techniques to help reduce muscle tension and stress-related triggers. The exercises will be administered to participants for 12 weeks.
It is expected that fascia exercises and breathing exercises will have positive effects on headaches as a result of the applied treatments.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a prospective, three-arm, randomized controlled trial to evaluate the effectiveness of different exercise-based interventions in individuals with cervicogenic headache (CGH). CGH is a secondary headache resulting from dysfunction of the cervical spine and related structures, typically characterized by neck pain and restricted cervical mobility.
Participants diagnosed with CGH according to the International Classification of Headache Disorders (ICHD-3) criteria will be recruited from a physical therapy and rehabilitation clinic setting. Following informed consent, eligible participants will be randomly assigned to one of three study arms.
All participants will receive a standard physiotherapy program consisting of patient education and therapeutic exercises targeting cervical function. In addition to the basic protocol, intervention groups will receive either exercises that activate the thoracolumbar fascia or specific breathing exercises.
The primary outcome measure is the Headache Impact Test-6 (HIT-6). In addition, pain intensity, functional status, quality of life, and psychological status will be assessed using validated clinical instruments. Thoracolumbar fascia thickness will be evaluated using ultrasonography at predefined time points using a standardized measurement protocol to assess structural changes associated with the interventions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve N CAN, MD
- Phone Number: +905309421498
- Email: mervenur9830@gmail.com
Study Contact Backup
- Name: Pelin YILDIRIM, MD
- Phone Number: +905323801078
- Email: drpeliny@gmail.com
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34785
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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Contact:
- Merve N CAN, MD
- Phone Number: +905309421498
- Email: mervenur9830@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-60 years
- Diagnosis of cervicogenic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
- Headache duration of at least 3 months
- Presence of headache associated with cervical movement limitation or provoked by neck movement
- Pain intensity of ≥3 on the Visual Analog Scale (VAS) at baseline
- Ability to understand and comply with the study procedures
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Presence of other primary headache disorders (e.g., migraine, tension-type headache, cluster headache)
- Diagnosis of rheumatologic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus)
- Serious cervical spine pathologies (e.g., cervical myelopathy, spinal stenosis)
- Presence of neurological deficits or central nervous system disorders
- Received physical therapy for the cervical region within the past 3 months
- Severe psychiatric disorders or cognitive impairment that may interfere with participation
- Pregnancy
- Cardiopulmonary conditions contraindicating exercise
- Musculoskeletal disorders that may interfere with exercise adherence
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 |
|---|---|
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Active Comparator: Conventional Treatment Group
Participants in this group will receive conventional treatment consisting of postural education, cervical range of motion exercises, and stretching and strengthening exercises targeting the cervical and surrounding musculature.
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Participants in this group will receive a single initial session of conventional treatment, including postural education, cervical range of motion exercises, and stretching and strengthening exercises targeting the cervical and surrounding musculature.
Following this session, participants will be prescribed a structured home exercise program to be performed independently for 12 weeks without supervised sessions.
Participants will be asked to adhere to the home program throughout the intervention period.
Outcome assessments will be conducted at baseline, 12 weeks (post-intervention), and 24 weeks (follow-up).
Other Names:
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Experimental: Breathing Exercise Group
The breathing exercise program will consist of techniques focusing on diaphragmatic breathing and respiratory control.
This intervention aims to improve breathing patterns, enhance respiratory efficiency, and reduce accessory muscle overactivity.
Exercises will be performed under supervision throughout the intervention period.
This approach may contribute to the reduction of headache symptoms by improving respiratory function and reducing muscular tension.
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The breathing exercise program will consist of techniques focusing on diaphragmatic breathing and breath control.
This intervention aims to improve breathing patterns, increase respiratory efficiency, and reduce overactivity of accessory muscles.
The exercises will be performed under supervision, three sessions per week for twelve weeks.
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Experimental: Thoracolumbar Fascia Exercise Group
Participants in this group will undergo a structured, specifically designed, supervised thoracolumbar fascia-focused exercise program aimed at improving fascial mobility, neuromuscular control, and load transfer across the trunk and spine, which may contribute to the reduction of headache symptoms.
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The exercise program will consist of mobility, activation, and stabilization exercises targeting the thoracolumbar fascia.
The intervention is designed to improve fascial mobility, enhance force transmission, and optimize neuromuscular coordination of the trunk.
Exercises will be performed under supervision, consisting of three sessions per week for twelve weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention)
Time Frame: Baseline, 12 weeks (post-intervention)
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The Headache Impact Test (HIT-6) is a validated 6-item questionnaire used to assess the impact of headache on daily life.
Scores range from 36 to 78, with higher scores indicating greater headache-related disability.
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Baseline, 12 weeks (post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in headache frequency recorded by headache diary from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Headache frequency will be assessed using a headache diary and recorded as the number of headache days per week based on participant-reported entries.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Change in pain intensity measured by the Visual Analog Scale (VAS) from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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The Visual Analog Scale (VAS) is a validated tool used to assess pain intensity.
It consists of a 10 cm scale ranging from "no pain" to "worst imaginable pain," with higher scores indicating greater pain intensity.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Change in neck-related disability measured by the Neck Disability Index (NDI) from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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The Neck Disability Index (NDI) is a validated 10-item questionnaire used to assess neck-related disability and functional limitations.
Higher scores indicate greater disability.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Change in quality of life measured by the WHOQOL-BREF from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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The WHOQOL-BREF is a validated questionnaire developed by the World Health Organization to assess quality of life across four domains: physical health, psychological health, social relationships, and environment.
It consists of 26 items, with higher scores indicating better quality of life.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Change in Headache Impact Test (HIT-6) score from baseline to 24 weeks (follow-up)
Time Frame: Baseline, 24 weeks (follow-up)
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The Headache Impact Test (HIT-6) is a validated 6-item questionnaire used to assess the impact of headache on daily life.
Scores range from 36 to 78, with higher scores indicating greater headache-related disability.
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Baseline, 24 weeks (follow-up)
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Changes in depression scores as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Depression levels will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Higher scores indicate greater depressive symptoms.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Change in thoracolumbar fascia thickness measured by ultrasound
Time Frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Ultrasound imaging will be used to assess thoracolumbar fascia thickness at predefined anatomical landmarks using a standardized measurement protocol.
Measurements will be performed with participants in a standardized position using a linear transducer, and the mean of repeated measurements will be recorded in millimeters.
Higher or lower values will be interpreted according to change over time and between-group comparisons.
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Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders
- Headache Disorders, Secondary
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Post-Traumatic Headache
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Breathing Exercises
Other Study ID Numbers
- MNINCE-2026-CGH01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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