A Randomized Controlled Pilot Exploratory Study on the Impact of Cessation of Toothpaste in Patients With Migraine Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Headache frequency
研究概览
简要总结
Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, we will be replacing toothpaste with saline water in a group of persons with migraine and compare them with another group of persons with migraine who will continue the use of toothpaste.
Both the groups will have the same treatment protocol with the only difference being the intervention of changing the toothpaste with saline.
This study will show whether this lifestyle intervention can improve headache frequency in persons with migraine over a four week period.
详细描述
Migraine headaches affect approximately 40% of the population and is one of the most prevalent and disabling neurological disorders worldwide. Although there are currently several medications available for the prevention of migraine attacks a majority of patients, with chronic and episodic migraines have experienced treatment failure, which greatly affects their personal, social and professional lives. Commonly used migraine preventive therapies such as topiramate, propranolol, amitriptyline and valproate may have unacceptable side effects leading to poor adherence.
Few recent papers have implicated substances in toothpaste to trigger headache attacks. Multiple ingredients in commonly used toothpaste such as nitrates, fluorides, benzoate, sorbitol, eucalyptol, camphor, etc., have the potential to cause headaches.
In this randomized physician-blinded controlled pilot exploratory study, we report the impact of toothpaste cessation on headache frequency and severity in patients with migraine headaches (PwM).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-59 years of age who had migraine with or without aura and who were not on any prophylactic medicines will be enrolled for participation in the study. Migraine is defined in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD3).
排除标准
- •Patients with a history of hemiplegic migraine, cluster headache, and other trigeminal autonomic cephalalgias, and secondary headaches will be excluded.
研究组 & 干预措施
Toothpaste Cessation Arm
This is the group that will be asked to replace toothpaste with saline
干预措施: Toothpaste Cessation (Other)
Toothpaste Continuation Arm
This is the group that will continue using toothpaste
结局指标
主要结局
Headache frequency
时间窗: 4 weeks
The primary outcome of the study is to assess the change in the mean number of headache days from baseline to the fourth week.
次要结局
- Headache Severity(4 weeks)
研究者
Thomas Mathew
Professor
St.John's National Academy of Health Sciences