Die Rolle der Faszie und Atemübungen bei der Behandlung von zervikogenem Kopfschmerz
Die Rolle von Faszien- und Atemübungen in der Behandlung von zervikogenen Kopfschmerzen: Eine randomisierte kontrollierte Studie
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Istanbul
-
Istanbul, Istanbul, Türkei (türkiye), 34785
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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. |
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).
Andere Namen:
|
|
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. |
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. |
|
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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Headache Impact Test (HIT-6) score from baseline to 12 weeks (post-intervention)
Zeitfenster: 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. |
Baseline, 12 weeks (post-intervention)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in headache frequency recorded by headache diary from baseline to 12 weeks (post-intervention) and 24 weeks (follow-up)
Zeitfenster: Baseline, 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. |
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)
Zeitfenster: Baseline, 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. |
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)
Zeitfenster: Baseline, 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. |
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)
Zeitfenster: Baseline, 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. |
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)
Zeitfenster: Baseline, 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. |
Baseline, 24 weeks (follow-up)
|
|
Changes in depression scores as measured by the Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
|
Depression levels will be assessed using the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate greater depressive symptoms. |
Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
|
|
Change in thoracolumbar fascia thickness measured by ultrasound
Zeitfenster: Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
|
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. |
Baseline, 12 weeks (post-intervention), and 24 weeks (follow-up)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Kopfschmerzen
- Kopfschmerzen, sekundär
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Schmerzen
- Posttraumatischer Kopfschmerz
- Therapeutika
- Mind-Body-Therapien
- Komplementäre Therapien
- Bewegungsbewegungstechniken
- Physiotherapiemodalitäten
- Atemübungen
Andere Studien-ID-Nummern
- MNINCE-2026-CGH01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .