Carotid sinus massage with head-down (Trendelenburg) positioning for headache relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

An initial open-label pilot of 17 participants showed feasibility and preliminary safety and efficacy for carotid sinus massage combined with the Trendelenburg position. The planned phase is a randomized, sham-controlled, parallel-arm trial enrolling 18 participants (9 per arm) to compare active CSM+Trendelenburg versus a sham procedure for acute headache relief. The design targets headache episodes that began within the prior 24 hours and follows standard exclusion criteria for carotid massage and head-down positioning. Outcomes will focus on symptom relief and safety with statistical power set at 80% and α = 0.05.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

* 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):

  * Migraine
  * Tension-type headache
  * Mixed headache
* The headache episode must have started within the past 24 hours.

EXCLUSION CRITERIA:

* 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

Where it's running

• Hospital Pedro T.Orellana, Trenque Lauquen
  Trenque Lauquen, Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Pablo D Anaya, MD — Hospital Municipal Pedro T. Orellana
• Study coordinator: Heberto J Suarez-Roca, MD, PhD
• Email: heberto.suarez.roca@duke.edu
• Phone: +1 (919) 6815688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.