RecruitingNot ApplicableNCT06745648

Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study


Sponsor

Hospital Municipal Pedro T. Orellana

Enrollment

18 participants

Start Date

Dec 21, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 16 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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

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Interventions

PROCEDUREArm A - Carotid Sinus Massage + Trendelenburg (CSM+T)

Manual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.

PROCEDUREArm B - Sham CSM+T

Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.


Locations(1)

Hospital Pedro T.Orellana, Trenque Lauquen

Trenque Lauquen, Buenos Aires, Argentina

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NCT06745648


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