Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID06745648

Effectiveness of Carotid Sinus Massage with Modified Trendelenburg Position for Acute Headache Relief

Led by Hospital Municipal Pedro T. Orellana · Updated on 2025-06-15

18

Participants Needed

1

Research Sites

N/A

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, including migraines and tension-type headaches, can greatly affect quality of life. Research suggests that blood pressure control and baroreceptor function may influence headache symptoms. An initial open-label pilot study with 17 participants showed that carotid sinus massage combined with the modified Trendelenburg position was feasible and safe, prompting a follow-up randomized trial to further study this treatment's effects. In the randomized phase, participants will be divided into two groups. One group will receive carotid sinus massage while lying in a 10-15° head-down Trendelenburg position, with massages lasting about 5 seconds and repeated up to three times at one-minute intervals. The control group will receive a sham massage that lightly touches the neck away from the carotid sinus but mimics the timing and positioning of the treatment group. Participants who do not experience relief after the sham will be offered rescue therapy, including the real treatment or medication as appropriate. Participants will have their headache pain intensity, blood pressure, heart rate, and oxygen levels measured before and 15 minutes after the intervention. Researchers will also track the rate of complete pain relief at 15 minutes, headache recurrence within 24 hours, and any adverse events up to 24 hours after treatment. The study plans to enroll 18 participants and will monitor outcomes closely to assess the treatment's potential benefits and safety.

CONDITIONS

Brief Title

Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be at least 16 years of age
  • Diagnosis of migraine, tension-type headache, or mixed headache according to International Classification of Headache Disorders
  • Headache episode started within the past 24 hours
Not Eligible

You will not qualify if you...

  • Contraindications to carotid sinus massage such as carotid bruits, recent myocardial infarction, history of stroke, or known/suspected carotid artery stenosis
  • Contraindications to Trendelenburg position including increased intracranial pressure, respiratory distress, congestive heart failure, history of syncope, or history of cardiac arrhythmias

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit with assessments up to 24 hours post-intervention

Participants receive either carotid sinus massage combined with Trendelenburg positioning or a sham procedure to assess relief from acute headaches. Pain intensity and vital signs are assessed before and after the intervention.

1 treatment visit with follow-up assessments within 24 hours

Trial Site Locations

Total: 1 location

1

Hospital Pedro T.Orellana, Trenque Lauquen

Trenque Lauquen, Buenos Aires, Argentina, 6400

Actively Recruiting

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Research Team

H

Heberto J Suarez-Roca, MD, PhD

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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