Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in headache pain intensity
研究概览
简要总结
Headaches significantly impact patients' quality of life, with tension-type headaches and migraines being among the most prevalent types. There is growing evidence suggesting that blood pressure regulation and baroreceptor activity play a role in headache pathophysiology. Carotid sinus massage (CSM), particularly when combined with the modified Trendelenburg position, may modulate autonomic nervous system activity to relieve headache symptoms.
An initial open-label pilot study (n = 17) was completed, and the results were published in a preprint server for health sciences, the Medical Research Archive (medRxiv), demonstrating the feasibility, safety, and promising preliminary efficacy of CSM+T. Based on these findings, a follow-up randomized, sham-controlled, parallel-arm trial will further evaluate the efficacy of the treatment.
详细描述
This protocol includes two study phases:
- Pilot Phase (Completed): A single-arm, open-label pilot study was conducted in 17 participants to assess the feasibility and safety of CSM+T for the relief of headaches. Results have been published in medRxiv and support continued investigation.
- Parallel-Arm Phase (Planned): A randomized, sham-controlled, parallel-arm clinical trial will now be implemented to evaluate efficacy. This phase will enroll 18 participants (9 per arm) to detect a clinically meaningful difference in headache relief with 80% power (α = 0.05, two-sided), accounting for potential attrition.
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)
盲法说明
In this single-blinded design, the patients do not know whether they are receiving the real CSM+T or the sham intervention, ensuring unbiased reporting of pain outcomes. However, it is not possible to double-blind (i.e., also blind the healthcare providers) because the clinicians administering CSM+T or the sham procedure must be aware of which maneuver they are performing, making true double-blinding impractical in this hands-on intervention study.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 16 years of age.
- •Must have a diagnosis of one of the following, according to the International Classification of Headache Disorders (ICHD-3):
- •Tension-type headache
- •Mixed headache
- •The headache episode must have started within the past 24 hours.
排除标准
- •Any contraindication to carotid sinus massage, including:
- •Carotid bruits
- •Recent myocardial infarction
- •History of stroke
- •Known or suspected carotid artery stenosis
- •Any contraindication to the Trendelenburg position, including:
- •Increased intracranial pressure
- •Respiratory distress
- •Congestive heart failure
- •History of syncope
- •History of cardiac arrhythmias
结局指标
主要结局
Change in headache pain intensity
时间窗: Baseline to 15 minutes post-intervention
Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)
次要结局
- Change in blood pressure(Baseline to 15 minutes post-intervention)
- Change in heart rate(Baseline to 15 minutes post-intervention)
- Change in oxygen saturation(Baseline to 15 minutes post-intervention)
- Percentage of participants with complete pain relief (VAS = 0)(15 minutes post-intervention)
- Headache recurrence rate(24 hours post-intervention)
- Incidence of adverse events(Up to 24 hours post-intervention)
研究者
Pablo D. Anaya, MD
Principal Investigator
Hospital Municipal Pedro T. Orellana