Tension-Type Headache
Conditions
Keywords
Tension-Type Headache, Vagus Nerve Stimulation
Brief summary
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.
Detailed description
Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population. There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.
Interventions
taVNS will be applied for a total of 12 sessions, 20 minutes each session, 3 days/week.
Sponsors
Bitlis Eren University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria, * Individuals between the ages of 18-65,
Exclusion criteria
* History of trauma or surgery to the head and neck region, * Presence of lesions or metal implants in the application area, * Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion, * Pregnancy or suspicion, * Other primary and secondary headache types, * Individuals who received physiotherapy in the last 6 months,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Change from baseline at 4 weeks | In the headache diary, the severity of the pain will be questioned with a numerical pain scale. |
| Pain duration | Change from baseline at 4 weeks | The duration of pain will be questioned in the headache diary. |
| Number of days of pain for 1 month | Change from baseline at 4 weeks | The number of days of pain during a month will be questioned in the headache diary. |
| Heart rate variability | Change from baseline at 4 weeks | Heart rate variability will be measured with an automatic device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Scale | Change from baseline at 4 weeks | It is a 6-item scale assessing vitality, pain, psychological state, social, role and cognitive function. The total score of the scale varies between 36-78; higher scores indicate a higher level of impact on the quality of life of the individual. |
| Depression Anxiety Stress Scale (DASS-21) | Change from baseline at 4 weeks | It evaluates the condition of the individual in the last week. It is a 21-question questionnaire consisting of 3 subscales: depression, anxiety and stress. The questionnaire score ranges from 0 to 21 for each subgroup. High scores indicate the presence and severity of depression, anxiety and stress. |
Countries
Turkey (Türkiye)
Outcome results
None listed