NCT05662722

Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

Use of Infrared Thermography in the Measurement of Facial Blood Flow After the Application of Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Alcala · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. There are different therapeutic approaches for the improvement of headache. Transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. On the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. The objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. As a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". In addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.

Conditions

• Headache

Interventions

Type	Name	Description
OTHER	percutaneous needle electrolysis	It´s an intervention of physiotherapy. It´s an invasive technique.
OTHER	Dry needling	It´s an intervention of physiotherapy. It´s an invasive technique.
OTHER	Sham needling	It´s an intervention of physiotherapy. It´s an invasive technique simulation.

Timeline

• Start date: 2022-03-22
• Primary completion: 2025-09-26
• Completion: 2025-12-01
• First posted: 2022-12-22
• Last updated: 2024-10-16

Locations

1 site across 1 country: Spain