Carotid Sinus Massage in Trendelenburg Position for Headache Relief

Hospital Municipal Pedro T. Orellana

Status: Enrolling

Conditions: Tension-Type Headache; Migraine

Treatments: Procedure: Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T); Procedure: Arm B - Sham CSM+T

Study type: Interventional

Funder types: Other

Identifiers

NCT06745648

HMPTOrellana

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

18 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Arm B - Sham CSM+T

Sham Comparator group

Description:

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.

Treatment:

Procedure: Arm B - Sham CSM+T