The Effect of Auricular Vagus Nerve Stimulation on Pain and Pulse Variability in Women With Migraine Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Numerical Pain Rating Scale
研究概览
简要总结
The aim of the study was to investigate the effectiveness of non-invasive auricular vagus nerve stimulation on pain and pulse variability in women aged 18-55 years with migraine. It is also aimed to see the effects of vagus nerve stimulation from all directions by making pain, pulse, blood pressure and autonomic measurements.
详细描述
Migraine, a neurological disorder that causes severe disability, is characterized by recurrent moderate to severe attacks associated with vegetative symptoms. Patients with frequent attacks may overuse drugs, which can lead to migraine chronization and headache. In the last decade, neuromodulatory approaches have been developed for the treatment of headaches that do not respond adequately to treatment. Non-invasive neuromodulation techniques are an evolving field in migraine research and treatment. Non-invasive vagus nerve stimulation is one of the non-invasive neuromodulation techniques. Promising findings on vagus nerve stimulation in people with chronic pain, including migraine and cluster headaches, are slowly being recognized. Stimulation of the vagus nerve provides a way of regulating autonomic tone. Auricular vagus nerve stimulation regulates abnormal sympatho-vagal balance while activating the parasympathetic system, including anti-inflammatory pathways (cholinergic anti-inflammatory pathway and hypothalamic-pituitary adrenal axis). It is aimed to evaluate the effect on pain and pulse variability after vagus nerve stimulation in women with migraine disease and to learn how the vagus nerve crosses according to the pulse measurements taken from the right and left index fingers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •People between the ages of 18-55 with migraine disease
- •Having a definite diagnosis of migraine by a neurologist
- •Absence of any orthopedic, neurological, etc. diseases that will prevent physical activity
- •Not using drugs continuously except for migraine attacks
- •Willingness to participate in the study
- •Having signed the informed consent form
排除标准
- •Cases do not want to continue the study.
- •Not signing the informed consent form
- •Being on medication for migraine prophylaxis
- •Having a communication problem that does not allow evaluation
- •Having a history of additional chronic disease that interferes with physical activity,
- •Pregnancy
结局指标
主要结局
Numerical Pain Rating Scale
时间窗: 1 month
The Numerical Pain Rating Scale is a widely used scale that requires the patient to rate their pain on a scale of 0 to 10; 0 indicates no pain and 10 reflects the worst possible pain.
Headache Impact Test (HIT-6)
时间窗: 1 month
It is a short questionnaire designed to evaluate migraine pain from the patient's perspective and to track the time lost by the patient due to migraine (work, school, housework, social activities).
Pulse Variability/ Elite HRV Cor Sense Monitor
时间窗: 1 month
CorSense HRV monitors are used in this study Elite HRV purchased from the company. Readings will be collected through the Elite HRV app designed for mobile devices. The platform is R-R registered via industry standard, according to the Elite HRV website. ranges and defines 0.04-0.15 Hz waves as LF and 0.15-0.40 Hz waves as HF.
Blood Pressure
时间窗: 1 month
Blood pressure is the pressure that the heart creates on the vessel wall as it pumps blood through our body.
次要结局
未报告次要终点
研究者
Sule Okur
Lecturer, Physiotherapist
Bahçeşehir University