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It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS Group | Experimental | In addition to standard treatment, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) will be applied to this group. |
|
| Control roup | No Intervention | The control group will receive standard treatment ( patient education+lifestyle recommendations). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) | Other | taVNS will be applied for a total of 12 sessions, 20 minutes each session, 3 days/week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | In the headache diary, the severity of the pain will be questioned with a numerical pain scale. | Change from baseline at 4 weeks |
| Pain duration | The duration of pain will be questioned in the headache diary. | Change from baseline at 4 weeks |
| Number of days of pain for 1 month | The number of days of pain during a month will be questioned in the headache diary. | Change from baseline at 4 weeks |
| Heart rate variability | Heart rate variability will be measured with an automatic device. | Change from baseline at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Scale | 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. | Change from baseline at 4 weeks |
| Depression Anxiety Stress Scale (DASS-21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bitlis Eren Üniversitesi | Bitlis | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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. |
| Change from baseline at 4 weeks |
| D009422 | Nervous System Diseases |