Overview
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.
Description
This protocol includes two study phases:
- 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 of headaches. Results have been published in medRxiv and support continued investigation.
- Parallel-Arm Phase (Planned): A randomized, sham-controlled, parallel-arm clinical trial will now be implemented to evaluate efficacy. This phase will enroll 18 participants (9 per arm) to detect a clinically meaningful difference in headache relief with 80% power (α = 0.05, two-sided), accounting for potential attrition.
Eligibility
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