- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07657377
The Effects of Physiotherapy in Migraine
The Effects of Physiotherapy Applications in Individuals With Migraine
The aim of this study is to investigate the effects of a physiotherapy program including cervical muscle training and transcutaneous auricular vagus nerve stimulation (taVNS) on pain, functional status, quality of life, psychological status, and sleep quality in individuals with migraine.
Aperçu de l'étude
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie (Türkiye), 06560
- Recrutement
- Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital
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Contact:
- Nuriye Kayalı Şendur
- Numéro de téléphone: +90 312 212 66 66
- E-mail: ankaradhs7@saglik.gov.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Volunteering to participate in the study
- Being between 18 and 55 years of age
- Being diagnosed with migraine by a neurologist according to the International Classification of Headache Disorders 3 (ICHD-3) criteria
Exclusion Criteria:
- Diagnosis of other primary and/or secondary headaches in addition to migraine,
- Coexisting neurological and/or rheumatological diseases,
- Severe psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.),
- Pregnancy or lactation,
- Malignancy,
- Known arrhythmia or presence of any implanted electronic device,
- Presence of sensory loss in the application area,
- Having received physiotherapy or any other treatment in the head/neck region within the last 12 months,
- History of head/neck trauma or surgery within the last 12 months.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control Group
The control group will receive no intervention and will continue with their routine treatment. |
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Expérimental: Treatment Group
In addition to routine treatments, a physiotherapy program including transcutaneous auricular vagus nerve stimulation and cervical muscle exercises will be implemented. |
A physiotherapy program including taVNS and cervical muscle exercises |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Assessment
Délai: Baseline, 8th week (after treatment)
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Individuals' pain parameters will be assessed using a pain diary. |
Baseline, 8th week (after treatment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of Functional Status
Délai: Baseline, 8th week (after treatment)
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The Migraine Disability Assessment Scale will be used to determine the functional status associated with migraine. This scale aims to evaluate headache-related disability and the functionality of individuals diagnosed with migraine in daily and social activities. Score ranges are calculated as follows: Grade I: no loss or very little loss (0-5 days); Grade II: mild loss (6-10 days); Grade III: moderate loss (11-20 days); Grade IV: severe loss (21 days or more) |
Baseline, 8th week (after treatment)
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Quality of Life Assessment
Délai: Baseline, 8th week (after treatment)
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The Migraine-Specific Quality of Life Scale (Version 2.1) will be used to assess quality of life. The 14-item scale comprises three sections: role-limiting, role-preventing, and emotional function. Scores for each subsection range from 0 to 100. Higher scores indicate better health-related quality of life. |
Baseline, 8th week (after treatment)
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Assessment of Psychological State
Délai: Baseline, 8th week (after treatment)
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The Hospital Anxiety and Depression Scale will be used to assess psychological status. Of the 14 items comprising the scale, the 7 odd-numbered items assess anxiety disorder, while the 7 even-numbered items assess depression. The minimum and maximum scores patients can obtain on either subscale are 0 and 21, respectively. Higher scores indicate higher levels of depression and anxiety. |
Baseline, 8th week (after treatment)
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Sleep Quality Assessment
Délai: Baseline, 8th week (after treatment)
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The Single-Item Sleep Quality Scale will be used to assess sleep quality.In this scale, participants are asked the question, "How would you rate your sleep quality overall over the past 7 days?" Responses are obtained using a numerical rating ranging from 0 (Terrible) to 10 (Excellent) . |
Baseline, 8th week (after treatment)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AYBU-2026-05
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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