Carotid sinus massage with head-down (Trendelenburg) positioning for headache relief
Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study
This trial tests whether carotid sinus massage while lying with your head lower than your feet can relieve migraine or tension-type headaches that started within the last 24 hours.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Hospital Municipal Pedro T. Orellana Academic / other |
| Locations | 1 site (Trenque Lauquen, Buenos Aires) |
| Trial ID | NCT06745648 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 16 or older with a diagnosis of migraine, tension-type, or mixed headache per ICHD-3 whose current headache began within the past 24 hours and who have no contraindications to carotid massage or the Trendelenburg position.
Not a fit: People with contraindications to carotid sinus massage (for example carotid bruits, recent MI, prior stroke, suspected carotid stenosis) or to Trendelenburg positioning (for example increased intracranial pressure, respiratory distress, heart failure, history of syncope or cardiac arrhythmia) and those with headaches older than 24 hours are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a simple, non-drug bedside maneuver for rapid relief of acute migraine or tension-type headache.
How similar studies have performed: A small open-label pilot (n=17) published as a medRxiv preprint reported feasibility, safety, and promising preliminary benefit, but randomized sham-controlled evidence is not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Trenque Lauquen, Buenos Aires
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.