Clinical trial NCT06745648: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Tension-Type Headache
Keywords: Carotid Sinus Massage
Trendelenburg
Autonomic Nervous System
Lead sponsor: Hospital Municipal Pedro T. Orellana
Sponsor class: OTHER
Collaborators: name: Duke University Medical Center, Durham, NC
First posted: 2024-12-20
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in headache pain intensity
timeFrame: Baseline to 15 minutes post-intervention
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline to 15 minutes post-intervention
measure: Change in heart rate
timeFrame: Baseline to 15 minutes post-intervention
measure: Change in oxygen saturation
timeFrame: Baseline to 15 minutes post-intervention
measure: Percentage of participants with complete pain relief (VAS = 0)
timeFrame: 15 minutes post-intervention
measure: Headache recurrence rate
timeFrame: 24 hours post-intervention
measure: Incidence of adverse events
timeFrame: Up to 24 hours post-intervention
Other outcomes:
Locations:
city: Trenque lauquen
country: Argentina
facility: Hospital Pedro T.Orellana, Trenque Lauquen
state: Buenos Aires
Study officials:
affiliation: Hospital Municipal Pedro T. Orellana
name: Pablo D Anaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine
name: Heberto J Suarez-Roca, MD, PhD
role: STUDY_DIRECTOR
References: