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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06560
- Recruiting
- Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital
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Contact:
- Nuriye Kayalı Şendur
- Phone Number: +90 312 212 66 66
- Email: ankaradhs7@saglik.gov.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
The control group will receive no intervention and will continue with their routine treatment. |
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Experimental: 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Assessment
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of Functional Status
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBU-2026-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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