Carotid Sinus Massage in Trendelenburg Position for Headache Relief
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHospital Municipal Pedro T. Orellana
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be at least 16 years of age.
Migraine
Tension-type headache
Mixed headache
Disqualifiers
Carotid bruits
Recent myocardial infarction
History of stroke
Known or suspected carotid artery stenosis
Trial design
Design model
Parallel
Treatments tested in this trial
Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)
Procedure/SurgeryManual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.
Arm B - Sham CSM+T
Procedure/SurgeryLight neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)Experimental treatment 1 intervention
Group B: Arm B - Sham CSM+TSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in headache pain intensity
Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)
Time frame
Baseline to 15 minutes post-interventionSecondary outcomes
1
Change in blood pressure
Difference in systolic and diastolic blood pressure (mmHg) from baseline to 15 minutes after the intervention.
Time frame
Baseline to 15 minutes post-intervention2
Change in heart rate
Difference in heart rate (beats per minute) measured before and after the intervention to assess autonomic or cardiovascular effects of the treatment.
Time frame
Baseline to 15 minutes post-intervention3
Change in oxygen saturation
Difference in peripheral oxygen saturation (SpO₂, %) measured by pulse oximetry before and after the intervention.
Time frame
Baseline to 15 minutes post-intervention4
Percentage of participants with complete pain relief (VAS = 0)
Proportion of participants reporting a Visual Analog Scale (VAS) pain score of 0-indicating complete headache relief-15 minutes after the intervention. VAS scores range from 0 (no pain) to 10 (worst possible pain)
Time frame
15 minutes post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Municipal Pedro T. Orellana
Lead sponsor
Duke University Medical Center, Durham, NC
Collaborator
Source ClinicalTrials.gov