Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
- •Individuals between the ages of 18-65,
排除标准
- •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,
结局指标
主要结局
Pain intensity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Change from baseline at 4 weeks
Heart rate variability will be measured with an automatic device.
次要结局
- Headache Impact Scale(Change from baseline at 4 weeks)
- Depression Anxiety Stress Scale (DASS-21)(Change from baseline at 4 weeks)
研究者
Mesut Arslan
Assistant Professor
Bitlis Eren University