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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Argentina
Hospital Pedro T.Orellana, Trenque Lauquen
RECRUITING
Trenque Lauquen
Contact Information
Primary
Heberto J Suarez-Roca, MD, PhD
heberto.suarez.roca@duke.edu
+1 (919) 6815688
Time Frame
Start Date: 2024-12-21
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 18
Treatments
Experimental: Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)
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.
Sham_comparator: Arm B - Sham CSM+T
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Municipal Pedro T. Orellana
Collaborators: Duke University Medical Center, Durham, NC

This content was sourced from clinicaltrials.gov