MigraineNCT06745648
Carotid Sinus Massage in Trendelenburg Position for Headache Relief
A study testing Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) in people with Migraine and Tension-Type Headache, run by Hospital Municipal Pedro T. Orellana at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Migraine, Tension-Type Headache
- What is being tested?
- Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteArgentina
- Study dates
- 21 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- Increased intracranial pressure
- Respiratory distress
- Congestive heart failure
- History of syncope
- History of cardiac arrhythmias
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Pedro T.Orellana, Trenque Lauquen
Trenque Lauquen, Buenos Aires, 6400
Pablo D Anaya, MD, +54 (2392) 400954, pdanaya@gmail.com
Heberto J Suarez-Roca, MD, PhD, +1 (919) 6815688, heberto.suarez.roca@duke.edu
About this study
Official title: Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study
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.
Read the detailed description
This protocol includes two study phases:
- 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.
- 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.
- Conditions
- Migraine, Tension-Type Headache
- Being tested
- Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T), Arm B - Sham CSM+T
- Keywords
- Carotid Sinus Massage, Trendelenburg, Autonomic Nervous System
- Medical subject headings
- Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)Procedure or surgery
Manual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.
Arm B - Sham CSM+TProcedure or surgery
Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) | Experimental | 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. Receives: Procedure: Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) |
| Arm B - Sham CSM+T | Sham comparator | 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. Receives: Procedure: Arm B - Sham CSM+T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache pain intensity
Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)
Measured: Baseline to 15 minutes post-intervention
Secondary outcomes (6)
Change in blood pressure
Difference in systolic and diastolic blood pressure (mmHg) from baseline to 15 minutes after the intervention.
Measured: Baseline to 15 minutes post-intervention
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.
Measured: Baseline to 15 minutes post-intervention
Change in oxygen saturation
Difference in peripheral oxygen saturation (SpO₂, %) measured by pulse oximetry before and after the intervention.
Measured: Baseline to 15 minutes post-intervention
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)
Measured: 15 minutes post-intervention
Headache recurrence rate
Proportion of participants who experience recurrence of headache symptoms within 24 hours following the intervention.
Measured: 24 hours post-intervention
Incidence of adverse events
Number and type of adverse events reported within 24 hours of the intervention, including any hemodynamic instability, discomfort, or other complications.
Measured: Up to 24 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start21 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Municipal Pedro T. Orellana
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University Medical Center, Durham, NC
- Responsible party
- Principal investigator, Pablo D. Anaya, MD, Hospital Municipal Pedro T. Orellana
- Investigators
- Pablo D Anaya, MD, Principal investigator, Hospital Municipal Pedro T. OrellanaHeberto J Suarez-Roca, MD, PhD, Study director, Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745648
- Sponsor's protocol ID
- HMPTOrellana
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to study outcomes will be shared, including pain scores, physiological measurements (such as heart rate, blood pressure, and oxygen saturation), and adverse event reports. Data will be made available upon reasonable request after publication of the primary results.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study
- ClinicalTrials.gov ID
- NCT06745648
- Acronym / sponsor ID
- HMPTOrellana
- Conditions
- Migraine, Tension-Type Headache
- Keywords
- Carotid Sinus Massage, Trendelenburg, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hospital Municipal Pedro T. OrellanaUniversity, hospital or other
- Collaborators
- Duke University Medical Center, Durham, NC
- Study start
- 21 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) | Experimental | Procedure: 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. |
| Arm B - Sham CSM+T | Sham comparator | Procedure: Arm B - Sham CSM+TIn 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
- The headache episode must have started within the past 24 hours.
Key exclusion criteria (11 listed)
- Any contraindication to carotid sinus massage, including:
- Any contraindication to the Trendelenburg position, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 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. | Procedure or surgery | Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) |
| Arm B - Sham CSM+TLight neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention. | Procedure or surgery | Arm B - Sham CSM+T |
Primary outcome
Change in headache pain intensity
Time frame: Baseline to 15 minutes post-intervention
Change in self-reported pain intensity using a 10-point Visual Analog Scale (VAS)
6 secondary outcomes
Change in blood pressure
Time frame: Baseline to 15 minutes post-intervention
Change in heart rate
Time frame: Baseline to 15 minutes post-intervention
Change in oxygen saturation
Time frame: Baseline to 15 minutes post-intervention
Percentage of participants with complete pain relief (VAS = 0)
Time frame: 15 minutes post-intervention
Headache recurrence rate
Time frame: 24 hours post-intervention
Incidence of adverse events
Time frame: Up to 24 hours post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to study outcomes will be shared, including pain scores, physiological measurements (such as heart rate, blood pressure, and oxygen saturation), and adverse event reports. Data will be made available upon reasonable request after publication of the primary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo D Anaya, MD principal investigator
Hospital Municipal Pedro T. Orellana
Heberto J Suarez-Roca, MD, PhD study director
Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T) in people with Migraine and Tension-Type Headache, run by Hospital Municipal Pedro T. Orellana at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heberto J Suarez-Roca, MD, PhD (+1 (919) 6815688, heberto.suarez.roca@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache pain intensity (time frame: Baseline to 15 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.