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RECRUITING
NCT06745648
NA

Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Sponsor: Hospital Municipal Pedro T. Orellana

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-12-21

Completion Date

2025-12-30

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hospital Pedro T.Orellana, Trenque Lauquen

Trenque Lauquen, Buenos Aires, Argentina