The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Headache Intensity
研究概览
简要总结
Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT.
General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact.
General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be considered for this study if they suffer from classical or common migraine for at least 3 years.
- •Candidates will recruited from the clinical case load of Dr. Zahid Bajwa and the headache and pain management center at BIDMC.
- •Only patients older than 18 years of age,
- •Able to communicate clearly in English,
- •Able to give an informed consent will be considered as candidates.
- •No limitation of gender or race is justified and thus, it is open to all patients fulfilling criteria for migraine type headache.
- •Patients will be able to withdraw from the study at any time.
- •They will be included in the study if they meet the criteria for migraine with or without aura (Headache-classification-committee-of-the-International-Headache-Society 1988), if they had >4 migraine attacks each month for the previous year.
排除标准
- •Exclusion criteria will include cardiovascular or cerebrovascular disorders,
- •Cardiac risk factors and liver disease,
- •Uncontrolled hypertension,
- •Peripheral and central nervous system disorders that affect sensory functions (such as sensory neuropathies and chronic pain),
- •The use of opiates or other analgesic drugs for any reason, and the use of other prophylactic anti-migraine drugs.
- •Any patient with active hepatitis or elevated liver enzymes (based on their BIDMC medical record) will be excluded as well.
- •Employees who are under the direct supervision of the investigators will not participate in the study.
研究组 & 干预措施
1
Maxalt administration at onset of migraine
干预措施: Maxalt (Drug)
2
干预措施: placebo pill (Drug)
3
干预措施: Maxalt (Drug)
4
干预措施: placebo pills (Drug)
5
干预措施: Maxalt (Drug)
6
干预措施: placebo pills (Drug)
结局指标
主要结局
Change in Headache Intensity
时间窗: 2 hours after treatment
The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Pain Free at 2 Hours After Treatment(2 hours after treatment)
研究者
Rami Burstein
Professor
Beth Israel Deaconess Medical Center