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NCT Number: NCT06745648

Carotid Sinus Massage in Trendelenburg Position for Headache Relief

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This protocol includes two study phases:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)

Procedure

Manual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.

Arm B - Sham CSM+T

Procedure

Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.

Primary outcomes

  1. Change in headache pain intensity

    Time frame: Baseline to 15 minutes post-intervention

    Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline to 15 minutes post-intervention

    Difference in systolic and diastolic blood pressure (mmHg) from baseline to 15 minutes after the intervention.

  2. Change in heart rate

    Time frame: 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.

  3. Change in oxygen saturation

    Time frame: Baseline to 15 minutes post-intervention

    Difference in peripheral oxygen saturation (SpO₂, %) measured by pulse oximetry before and after the intervention.

  4. Percentage of participants with complete pain relief (VAS = 0)

    Time frame: 15 minutes post-intervention

    Proportion of participants reporting a Visual Analog Scale (VAS) pain score of 0-indicating complete headache relief-15 minutes after the intervention.

    VAS scores range from 0 (no pain) to 10 (worst possible pain)

  5. Headache recurrence rate

    Time frame: 24 hours post-intervention

    Proportion of participants who experience recurrence of headache symptoms within 24 hours following the intervention.

  6. Incidence of adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heberto J Suarez-Roca, MD, PhD

CONTACT

[email protected]

+1 (919) 6815688

Sponsors and collaborators

Lead sponsor

Hospital Municipal Pedro T. Orellana

Other

Collaborators

  • Duke University Medical Center, Durham, NC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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