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
Sponsors and collaborators
Hospital Municipal Pedro T. Orellana
Lead sponsor
Duke University Medical Center, Durham, NC
Collaborator