Migraine, Tension-Type Headache
Conditions
Keywords
Carotid Sinus Massage, Trendelenburg, Autonomic Nervous System
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.
Interventions
PROCEDUREArm 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.
PROCEDUREArm B - Sham CSM+T
Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.
Sponsors
Duke University Medical Center, Durham, NC
Hospital Municipal Pedro T. Orellana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
In this single-blinded design, the patients do not know whether they are receiving the real CSM+T or the sham intervention, ensuring unbiased reporting of pain outcomes. However, it is not possible to double-blind (i.e., also blind the healthcare providers) because the clinicians administering CSM+T or the sham procedure must be aware of which maneuver they are performing, making true double-blinding impractical in this hands-on intervention study.
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache pain intensity | Baseline to 15 minutes post-intervention | Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | Baseline to 15 minutes post-intervention | Difference in heart rate (beats per minute) measured before and after the intervention to assess autonomic or cardiovascular effects of the treatment. |
| Change in oxygen saturation | Baseline to 15 minutes post-intervention | Difference in peripheral oxygen saturation (SpO₂, %) measured by pulse oximetry before and after the intervention. |
| Change in blood pressure | Baseline to 15 minutes post-intervention | Difference in systolic and diastolic blood pressure (mmHg) from baseline to 15 minutes after the intervention. |
| Incidence of adverse events | Up to 24 hours post-intervention | Number and type of adverse events reported within 24 hours of the intervention, including any hemodynamic instability, discomfort, or other complications. |
| Headache recurrence rate | 24 hours post-intervention | Proportion of participants who experience recurrence of headache symptoms within 24 hours following the intervention. |
| Percentage of participants with complete pain relief (VAS = 0) | 15 minutes post-intervention | 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) |
Countries
Argentina
Contacts
Primary ContactHeberto J Suarez-Roca, MD, PhD
Outcome results
None listed