Carotid Sinus Massage in Trendelenburg Position for Headache Relief
Recruiting · NCT06745648 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Municipal Pedro T. Orellana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Hospital Pedro T.Orellana, Trenque Lauquen - Trenque Lauquen, Buenos Aires, Argentina