Actively Recruiting
Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
Led by University of Alcala · Updated on 2026-05-01
60
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Headache with a frequency of at least one monthly episode.
- Present the "cold nose" and/or "cold patch" pattern
- Age between 18 and 70 years
You will not qualify if you...
- Do not present a "cold nose" and/or "cold patch" pattern
- Pregnant women
- Subjects with facial alterations that may affect facial vascularization (sinusitis, allergies...)
- Patients with belonephobia or allergy to metals or any material used in the procedure.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Physioterapy and Pain center research
Alcalá de Henares, Madrid, Spain, 28805
Actively Recruiting
Research Team
D
David Álvarez, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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