Efficacy of combination of therapeutic patient education with standard of care versus standard of care alone for the management of chronic migraine: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in Migraine Specific Quality of Life Score from baseline per 4 weeks for weeks 9-12 weeks
研究概览
简要总结
The study is a randomised control trial to objectively measure the efficacy of therapeutic patient education with standard of care compared with standard of care alone for the management of chronic migraine.
Chronic migraine is a prevalent, debilitating condition that affects patients lifelong and hampers their everyday life and productivity. While drug treatment is available, it comes with its own caveat of Medicine Overuse Headache (MOH), and other side effects. There is burning need for behavioral interventions such as education to make lifestyle modifications that lead towards better patient outcome. This is key to health promotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Any patient fulfilling diagnostic criteria for chronic migraine with or without aura as laid by ICHD-3 (International Classification of Headache Disorders).
排除标准
- •All patients with a clinical phenotype of chronic migraine but on further investigation, found to have a secondary cause for their headache.
结局指标
主要结局
Change in Migraine Specific Quality of Life Score from baseline per 4 weeks for weeks 9-12 weeks
时间窗: 12 weeks
次要结局
- Change in mean Headache Impact Test-6 from baseline per 4 weeks for weeks 9-12 weeks(12 weeks)
- Change in mean Migraine Disability Assessment from baseline per 4 weeks for weeks 9-12 weeks(12 weeks)