Cervicogenic HeadacheNCT07518108
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
A study testing Thoracolumbar Fascia Exercise, Breathing Exercise and Conventional treatment in people with Cervicogenic Headache, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Thoracolumbar Fascia Exercise, Breathing Exercise and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Cardiopulmonary conditions contraindicating exercise
- Musculoskeletal disorders that may interfere with exercise adherence
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul, Istanbul, 34785
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Thoracolumbar Fascia Exercise, Breathing Exercise, Conventional treatment
- Keywords
- Thoracolumbar Fascia, Fascia Exercise, Breathing Exercise, Randomized Controlled Trial, Pain, Physical Therapy, Headache Impact Test, Cervicogenic Headache, Fascia thickness, Ultrasound imaging
- Medical subject headings
- Post-Traumatic Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar Fascia ExerciseOther
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.
Breathing ExerciseOther
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.
Conventional treatmentOther
Also called Control
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Group | Active comparator | 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. Receives: Other: Conventional treatment |
| Breathing Exercise Group | Experimental | 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. Receives: Other: Breathing Exercise |
| Thoracolumbar Fascia Exercise Group | Experimental | 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. Receives: Other: Thoracolumbar Fascia Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention)
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.
Measured: Baseline, 12 weeks (post-intervention)
Secondary outcomes (7)
Change in headache frequency recorded by headache diary from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Headache frequency will be assessed using a headache diary and recorded as the number of headache days per week based on participant-reported entries.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Change in pain intensity measured by the Visual Analog Scale (VAS) from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
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.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Change in neck-related disability measured by the Neck Disability Index (NDI) from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
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.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Change in quality of life measured by the WHOQOL-BREF from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
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.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Change in Headache Impact Test (HIT-6) score from baseline to 24 weeks (follow-up)
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.
Measured: Baseline, 24 weeks (follow-up)
Changes in depression scores as measured by the Hospital Anxiety and Depression Scale (HADS)
Depression levels will be assessed using the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate greater depressive symptoms.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Change in thoracolumbar fascia thickness measured by ultrasound
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.
Measured: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Apr 2026
- Primary completion15 Oct 2026
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a three-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to one of the following groups using a computer-generated randomization sequence: a thoracolumbar fascia-focused exercise group, a breathing exercise group, or a control group receiving conventional treatment. All interventions will be administered over a defined treatment period, and outcome measures will be assessed at baseline, post-intervention, and at follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518108
- Sponsor's protocol ID
- MNINCE-2026-CGH01
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07518108
- Acronym / sponsor ID
- MNINCE-2026-CGH01
- Conditions
- Cervicogenic Headache
- Keywords
- Thoracolumbar Fascia, Fascia Exercise, Breathing Exercise, Randomized Controlled Trial, Pain, Physical Therapy, Headache Impact Test, Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is designed as a three-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to one of the following groups using a computer-generated randomization sequence: a thoracolumbar fascia-focused exercise group, a breathing exercise group, or a control group receiving conventional treatment. All interventions will be administered over a defined treatment period, and outcome measures will be assessed at baseline, post-intervention, and at follow-up.
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Group | Active comparator | Other: Conventional treatmentParticipants 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. |
| Breathing Exercise Group | Experimental | Other: Breathing ExerciseThe 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. |
| Thoracolumbar Fascia Exercise Group | Experimental | Other: Thoracolumbar Fascia ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbar Fascia ExerciseThe 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. | Other | Thoracolumbar Fascia Exercise Group |
| Breathing ExerciseThe 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. | Other | Breathing Exercise Group |
| Conventional treatmentAlso: ControlParticipants 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 | Conventional Treatment Group |
Primary outcome
Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention)
Time frame: Baseline, 12 weeks (post-intervention)
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.
7 secondary outcomes
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)
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)
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)
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)
Change in Headache Impact Test (HIT-6) score from baseline to 24 weeks (follow-up)
Time frame: Baseline, 24 weeks (follow-up)
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)
Change in thoracolumbar fascia thickness measured by ultrasound
Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar Fascia Exercise, Breathing Exercise and Conventional treatment in people with Cervicogenic Headache, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention) (time frame: Baseline, 12 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.