MedTrace Logo

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

NCT05662722 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Alcala

    lead OTHER

Principal Investigators

  • Daniel Pecos-Martin, PhD · Alcala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2026-09-26
Completion
2027-12-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05662722 on ClinicalTrials.gov