Carotid Sinus Massage in Trendelenburg Position for Headache Relief

NCT06745648 | Recruiting DMC

• 1 other identifier: HMPTOrellana
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Tension-Type Headache

Keywords

Carotid Sinus Massage; Trendelenburg; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Change in headache pain intensity

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

  Baseline to 15 minutes post-intervention

Secondary Outcomes (6)

• Change in blood pressure

  Baseline to 15 minutes post-intervention

• Change in heart rate

  Baseline to 15 minutes post-intervention

• Change in oxygen saturation

  Baseline to 15 minutes post-intervention

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

  15 minutes post-intervention

• Headache recurrence rate

  24 hours post-intervention

Study Arms (2)

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

EXPERIMENTAL

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.

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

Arm B - Sham CSM+T

SHAM COMPARATOR

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.

Procedure: Arm B - Sham CSM+T

Interventions

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

Arm B - Sham CSM+T PROCEDURE

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

Arm B - Sham CSM+T

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Municipal Pedro T. Orellana: lead
• Duke University Medical Center, Durham, NC: collaborator

Study Sites (1)

Hospital Pedro T.Orellana, Trenque Lauquen

Trenque Lauquen, Buenos Aires, 6400, Argentina

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pablo D Anaya, MD

  Hospital Municipal Pedro T. Orellana

  PRINCIPAL INVESTIGATOR

• Heberto J Suarez-Roca, MD, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Heberto J Suarez-Roca, MD, PhD

CONTACT

+1 (919) 6815688; heberto.suarez.roca@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this single-blinded design, the patients do not know whether they are receiving the real CSM+T or the sham intervention, ensuring unbiased reporting of pain outcomes. However, it is not possible to double-blind (i.e., also blind the healthcare providers) because the clinicians administering CSM+T or the sham procedure must be aware of which maneuver they are performing, making true double-blinding impractical in this hands-on intervention study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to one of two parallel arms: (1) real carotid sinus massage in the Trendelenburg position (CSM+T), or (2) a sham neck massage in the same position. The primary outcome will compare immediate post-intervention headache intensity between groups.

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: December 21, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be made available beginning 6 months after publication of the primary results and will remain available for a minimum of 5 years thereafter.
• Access Criteria: Qualified researchers may request access to the data by submitting a data use proposal, which should include a brief description of the study objectives and statistical plan. Requests will be reviewed by the study investigators or a designated data access committee. Data will be shared via secure transfer methods, subject to a data use agreement, to ensure participant confidentiality.

Locations

AR (1)