Status:
RECRUITING
Carotid Sinus Massage in Trendelenburg Position for Headache Relief
Lead Sponsor:
Hospital Municipal Pedro T. Orellana
Collaborating Sponsors:
Duke University Medical Center, Durham, NC
Conditions:
Migraine
Tension-Type Headache
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
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 regul...
Detailed Description
This protocol includes two study phases: 1. 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...
Eligibility 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
Key Trial Info
Start Date :
December 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06745648
Start Date
December 21 2024
End Date
December 30 2025
Last Update
June 15 2025
Active Locations (1)
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1
Hospital Pedro T.Orellana, Trenque Lauquen
Trenque Lauquen, Buenos Aires, Argentina, 6400