Migraine
Conditions
Brief summary
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.
Interventions
A physiotherapy program including taVNS and cervical muscle exercises
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment | Baseline, 8th week (after treatment) | Individuals' pain parameters will be assessed using a pain diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Functional Status | Baseline, 8th week (after treatment) | 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) |
| Quality of Life Assessment | Baseline, 8th week (after treatment) | 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. |
| Assessment of Psychological State | Baseline, 8th week (after treatment) | 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. |
| Sleep Quality Assessment | Baseline, 8th week (after treatment) | 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) . |
Countries
Turkey (Türkiye)
Outcome results
None listed