Carotid Sinus Massage in Trendelenburg Position for Headache Relief (C-SMART)

Not Applicable

Not yet recruiting

• Conditions: Migraine; Tension-type Headache

• Registration Number: NCT06745648
• Lead Sponsor: Hospital Municipal Pedro T. Orellana

Brief Summary

Headaches significantly impact patients; quality of life, with tension-type headaches and migraines being common. Evidence suggests that blood pressure and baroreceptors play a role in headaches. Carotid sinus massage (CSM) and the modified Trendelenburg position, techniques that stimulate carotid baroreceptors, may modulate autonomic nervous system activity to relieve headaches. The present study will be evaluate the effectiveness and safety of CSM in the modified Trendelenburg position for immediate headache relief.

Patients suffering from headaches or migraines will be subjected to a CSM while in the modified Trendelenburg position. The procedure will be repeated after a one-minute interval, up to three times. Clinical characteristics, hemodynamic parameters, and treatment responses will be recorded. Pain intensity will be assessed using a 10-point visual analog scale (VAS) before and after the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study Start: 2024-12-20
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-01-24
• Study Completion: 2025-01-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patient with migraine
• Tension-type
• Mixed headache based on the International Classification of Headache Disorders.

Exclusion Criteria

• Contraindications for Carotid sinus massage: - carotid bruits
• recent myocardial infarction
• stroke, carotid stenosis
• Trendelenburg position: - increased intracranial pressure
• respiratory distress
• congestive heart failure
• No history of syncope or arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain intensity, will be assessed using the Visual Analogic Scale, (EVA)	baseline measurement before the carotid sinus massage (CSM) and 10 seconds after each of carotid sinus massage, and 24 hours later	The visual analogue scale for pain is a straight line with one end meaning no pain (0 value) and the other end meaning the worst pain imaginable (10 value) . The patient marks a point on the line that corresponds to the amount of pain he or she feels.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline measurement before the carotid sinus massage (CSM), and 10 seconds after completing the last 15-second CSM.	BP will measured using a multiparameter patient monitor.
Heart Rate	Baseline measurement before the carotid sinus massage (CSM), and 10 seconds after completing the last 15-second CSM.	Heart rate will be measured using a multiparameter patient monitor.
Oxygen Saturation	Baseline measurement before the carotid sinus massage (CSM), and 10 seconds after completing the last 15-second CSM.	Oxygen saturation will be measured using a multiparameter patient monitor.

Trial Locations

Locations (1)

Hospital Pedro T.Orellana, Trenque Lauquen; 🇦🇷 Trenque lauquen, Buenos Aires, Argentina