Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHospital Municipal Pedro T. Orellana

About this trial

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 criteria

Qualifiers

Participants must be at least 16 years of age.

Migraine

Tension-type headache

Mixed headache

Disqualifiers

Carotid bruits

Recent myocardial infarction

History of stroke

Known or suspected carotid artery stenosis

Trial design

Treatments tested in this trial

  • Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)
  • Arm B - Sham CSM+T

Treatment groups

18 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Municipal Pedro T. Orellana

Lead sponsor

Duke University Medical Center, Durham, NC

Collaborator