Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Official title

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

Overview

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.

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.

Primary outcome measures

• Change in headache pain intensity [Time frame: Baseline to 15 minutes post-intervention]

Secondary outcome measures (6)

• Change in blood pressure [Time frame: Baseline to 15 minutes post-intervention]
• Change in heart rate [Time frame: Baseline to 15 minutes post-intervention]
• Change in oxygen saturation [Time frame: Baseline to 15 minutes post-intervention]
• Percentage of participants with complete pain relief (VAS = 0) [Time frame: 15 minutes post-intervention]
• Headache recurrence rate [Time frame: 24 hours post-intervention]
• Incidence of adverse events [Time frame: Up to 24 hours post-intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Argentina · 1 center

• Hospital Pedro T.Orellana, Trenque Lauquen — Trenque Lauquen

Identifiers

NCT: NCT06745648 · HMPTOrellana

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗