Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Not Applicable

Recruiting

• Conditions: Tension-Type Headache; Migraine

• Registration Number: NCT06745648
• Lead Sponsor: Hospital Municipal Pedro T. Orellana

Brief 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.

Detailed Description

This protocol includes two study phases:

1. 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.

2. 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.

Study Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2024-12-21
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Participants must be at least 16 years old and have a diagnosis of migraine, tension-type headache, or mixed headache, as defined in the International Classification of Headache Disorders (ICHD-3). The headache episode must have begun within the past 24 hours.

Exclusion Criteria

Participants will be excluded if they have any contraindications to carotid sinus massage, including carotid bruits, recent myocardial infarction, a history of stroke, or known or suspected carotid artery stenosis. They will also be excluded if they have contraindications to the Trendelenburg position, such as increased intracranial pressure, respiratory distress, or congestive heart failure. Additionally, individuals with a history of syncope or cardiac arrhythmias will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in headache pain intensity	Baseline to 15 minutes post-intervention	Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 24 hours post-intervention	Number and type of adverse events reported within 24 hours of the intervention, including any hemodynamic instability, discomfort, or other complications.
Change in blood pressure	Baseline to 15 minutes post-intervention	Difference in systolic and diastolic blood pressure (mmHg) from baseline to 15 minutes after the intervention.
Change in heart rate	Baseline to 15 minutes post-intervention	Difference in heart rate (beats per minute) measured before and after the intervention to assess autonomic or cardiovascular effects of the treatment.
Change in oxygen saturation	Baseline to 15 minutes post-intervention	Difference in peripheral oxygen saturation (SpO₂, %) measured by pulse oximetry before and after the intervention.
Headache recurrence rate	24 hours post-intervention	Proportion of participants who experience recurrence of headache symptoms within 24 hours following the intervention.
Percentage of participants with complete pain relief (VAS = 0)	15 minutes post-intervention	Proportion of participants who report a Visual Analog Scale (VAS) pain score of 0 at 15 minutes after the intervention, indicating complete headache relief.

Trial Locations

Locations (1)

Hospital Pedro T.Orellana, Trenque Lauquen; 🇦🇷 Trenque lauquen, Buenos Aires, Argentina