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Not yet recruiting NCT07518108

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

No phase Interventional Cervicogenic Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thoracolumbar Fascia Exercise, Breathing Exercise, Conventional treatment.
Who it may be relevant to
Registry conditions: Cervicogenic Headache. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache: A Randomized Controlled Trial

Overview

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.

Interventions

  • Other Thoracolumbar 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.
  • Other Breathing 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.
  • Other Conventional 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

Primary outcome measures

  • Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention) [Time frame: Baseline, 12 weeks (post-intervention)]
Secondary outcome measures (7)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07518108 · MNINCE-2026-CGH01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗