NCT06745648

Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hospital Municipal Pedro T. Orellana · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Tension-Type Headache

Interventions

Type	Name	Description
PROCEDURE	Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)	Manual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.
PROCEDURE	Arm B - Sham CSM+T	Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.

Timeline

• Start date: 2024-12-21
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-12-20
• Last updated: 2025-06-15

Locations

1 site across 1 country: Argentina