NCT07518108

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 1, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

Thoracolumbar FasciaFascia ExerciseBreathing ExerciseRandomized Controlled TrialPainPhysical TherapyHeadache Impact TestCervicogenic HeadacheFascia thicknessUltrasound imaging

Outcome Measures

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.

    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)

    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)

    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)

    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)

    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)

    Baseline, 24 weeks (follow-up)

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Thoracolumbar Fascia Exercise

Interventions

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.

Thoracolumbar Fascia Exercise Group

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.

Breathing Exercise Group

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
Conventional Treatment Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Istanbul, 34785, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Traumatic HeadachePain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Pelin YILDIRIM, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by an assessor blinded to group allocation. Due to the nature of the interventions, participants and therapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations