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Active, not recruitingNCT07518108Updated Sep 22, 2026

The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache

An interventional study of Thoracolumbar Fascia Exercise and Breathing Exercise in Cervicogenic Headache, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cervicogenic Headache

Keywords

  • Thoracolumbar Fascia
  • Fascia Exercise
  • Breathing Exercise
  • Randomized Controlled Trial
  • Pain
  • Physical Therapy
  • Headache Impact Test
  • Cervicogenic Headache
  • Fascia thickness
  • Ultrasound imaging
03

In context

Post-Traumatic Headache

188 studies on the registry are indexed under Post-Traumatic Headache; 51 are open to participants now.

This study's planned enrollment of 72 is above the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.

Browse Post-Traumatic Headache studies →

Lead sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 38 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • 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.

    Other: Conventional treatment

  • 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.

    Other: Breathing Exercise

  • 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.

    Other: Thoracolumbar Fascia Exercise

Interventions

  • OtherThoracolumbar Fascia Exercise

    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.

  • OtherBreathing Exercise

    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.

  • OtherConventional treatment

    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).

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 12 weeks (post-intervention)

Secondary outcomes

  1. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

  2. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

  3. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

  4. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

  5. 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.

    Time frame: Baseline, 24 weeks (follow-up)

  6. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

  7. 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.

    Time frame: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)

07

Study locations

1 site
  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
    Istanbul, Istanbul 34785, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518108
Lead sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Apr 20, 2026
Primary completion
Oct 15, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Sep 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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