Actively Recruiting
Carotid Sinus Massage in Trendelenburg Position for Headache Relief
Led by Hospital Municipal Pedro T. Orellana · Updated on 2025-06-15
18
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
H
Hospital Municipal Pedro T. Orellana
Lead Sponsor
D
Duke University Medical Center, Durham, NC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Carotid Sinus Massage in Trendelenburg Position for Headache Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 16 years of age.
- Diagnosed with migraine, tension-type headache, or mixed headache according to ICHD-3.
- Current headache episode started within the past 24 hours.
You will not qualify if you...
- Contraindications to carotid sinus massage, including carotid bruits, recent myocardial infarction, history of stroke, or suspected carotid artery stenosis.
- Contraindications to Trendelenburg position, including increased intracranial pressure, respiratory distress, congestive heart failure, history of syncope, or cardiac arrhythmias.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Pedro T.Orellana, Trenque Lauquen
Trenque Lauquen, Buenos Aires, Argentina, 6400
Actively Recruiting
Research Team
H
Heberto J Suarez-Roca, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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