[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573389":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":37,"locations":42,"responsibleParty":62,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hospital Municipal Pedro T. Orellana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Arm A - Carotid Sinus Massage + Trendelenburg (CSM+T)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.\n\nParticipants 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.",[19],"Procedure: Arm B - Sham CSM+T",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Manual stimulation of the carotid sinus area combined with head-down tilt positioning to activate baroreceptors for headache relief.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Light neck contact, avoiding carotid sinus pressure, paired with identical body positioning to mimic the experimental intervention.",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Pablo D Anaya, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Heberto J Suarez-Roca, MD, PhD","Dule University Medical Center, Dept. of Anesthesiology, Center for Translational Pain Medicine","STUDY_DIRECTOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","+1 (919) 6815688","heberto.suarez.roca@duke.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital Pedro T.Orellana, Trenque Lauquen","RECRUITING","Trenque Lauquen","Buenos Aires","6400","Argentina","AR",{"type":52,"coordinates":53},"Point",[54,55],-62.73275,-35.97334,{"lat":55,"lon":54},[58,61],{"name":31,"role":39,"phone":59,"phoneExt":25,"email":60},"+54 (2392) 400954","pdanaya@gmail.com",{"name":34,"role":39,"phone":40,"phoneExt":25,"email":41},{"type":32,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Pablo D. Anaya, MD","Principal Investigator",[66],{"name":67,"class":68},"Duke University Medical Center, Durham, NC","UNKNOWN","100573389","carotid-sinus-massage-in-trendelenburg-position-for-headache-relief-100573389",false,"NCT06745648","Carotid Sinus Massage in Trendelenburg Position for Headache Relief","Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study","INCLUSION CRITERIA:\n\n* Participants must be at least 16 years of age.\n* Must have a diagnosis of one of the following, according to the International Classification of Headache Disorders (ICHD-3):\n\n  * Migraine\n  * Tension-type headache\n  * Mixed headache\n* The headache episode must have started within the past 24 hours.\n\nEXCLUSION CRITERIA:\n\n* Any contraindication to carotid sinus massage, including:\n\n  * Carotid bruits\n  * Recent myocardial infarction\n  * History of stroke\n  * Known or suspected carotid artery stenosis\n* Any contraindication to the Trendelenburg position, including:\n\n  * Increased intracranial pressure\n  * Respiratory distress\n  * Congestive heart failure\n  * History of syncope\n  * History of cardiac arrhythmias","ALL","16 Years",{"count":79,"type":80},18,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nAn 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.",[86,87],"Migraine","Tension-Type Headache",[89,90,91],"Carotid Sinus Massage","Trendelenburg","Autonomic Nervous System","2025-06-11",{"date":94,"type":95},"2025-06-15","ACTUAL",{"date":97,"type":95},"2024-12-21",{"date":99,"type":80},"2025-12-30",{"name":5,"class":6},1]