Carotid Sinus Massage in Trendelenburg Position for Headache Relief

NCT ID: NCT06745648

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-21
• Study Completion Date: 2025-12-30

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.

Conditions

Migraine; Tension-Type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Participants will receive carotid sinus massage (CSM) while positioned in a 10-15° Trendelenburg position. The massage is applied to the carotid sinus area for approximately 5 seconds and may be repeated up to three times, separated by one-minute intervals. Pain intensity and vital signs are assessed before and after the intervention.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

In the control group, patients will be placed in the supine position. Then, a sham neck massage will be performed by lightly touching the skin in a circular motion away from the carotid sinus, for the same duration and intervals as in the experimental procedure. This sham approach will ensure that any observed effects are attributable to carotid sinus stimulation rather than mere tactile stimulation of the neck.

Participants who do not report pain relief after the sham procedure will be offered rescue therapy, which may include the real CSM+Trendelenburg intervention or pharmacologic treatment, as clinically appropriate. The rescue response will be recorded for secondary analysis.

Group Type: SHAM_COMPARATOR

Arm B - Sham CSM+T

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Arm B - Sham CSM+T

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University Medical Center, Durham, NC

UNKNOWN

Sponsor Role: collaborator

Hospital Municipal Pedro T. Orellana

OTHER

Sponsor Role: lead

Responsible Party

Pablo D. Anaya, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo D Anaya, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Municipal Pedro T. Orellana

Heberto J Suarez-Roca, MD, PhD

Role: STUDY_DIRECTOR

Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine

Locations

Hospital Pedro T.Orellana, Trenque Lauquen

Trenque Lauquen, Buenos Aires, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Heberto J Suarez-Roca, MD, PhD

Role: CONTACT

heberto.suarez.roca@duke.edu

+1 (919) 6815688

Facility Contacts

Pablo D Anaya, MD

Role: primary

pdanaya@gmail.com

+54 (2392) 400954

Heberto J Suarez-Roca, MD, PhD

Role: backup

heberto.suarez.roca@duke.edu

+1 (919) 6815688

Other Identifiers

HMPTOrellana

Identifier Type: -

Identifier Source: org_study_id