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Carotid Sinus Massage in Trendelenburg Position for Headache Relief

NCT06745648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Duke University Medical Center, Durham, NC

    collaborator UNKNOWN

  • Hospital Municipal Pedro T. Orellana

    lead OTHER

Principal Investigators

  • Pablo D Anaya, MD · Hospital Municipal Pedro T. Orellana

  • Heberto J Suarez-Roca, MD, PhD · Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-21
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745648 on ClinicalTrials.gov