Effectiveness of Carotid Sinus Massage in Modified Trendelenburg Position for Acute Headache Episodes: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hospital Municipal Pedro T. Orellana
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in headache pain intensity
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Pablo D. Anaya, MD
Principal Investigator
Hospital Municipal Pedro T. Orellana
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Change in blood pressure(Baseline to 15 minutes post-intervention)
- Change in heart rate(Baseline to 15 minutes post-intervention)
- Change in oxygen saturation(Baseline to 15 minutes post-intervention)
- Percentage of participants with complete pain relief (VAS = 0)(15 minutes post-intervention)
- Headache recurrence rate(24 hours post-intervention)
- Incidence of adverse events(Up to 24 hours post-intervention)