RecruitingNot ApplicableNCT05662722

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


Sponsor

University of Alcala

Enrollment

60 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Headache with a frequency of at least one monthly episode.
  • Present the "cold nose" and/or "cold patch" pattern

Exclusion Criteria4

  • 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.

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Interventions

OTHERpercutaneous needle electrolysis

It´s an intervention of physiotherapy. It´s an invasive technique.

OTHERDry needling

It´s an intervention of physiotherapy. It´s an invasive technique.

OTHERSham needling

It´s an intervention of physiotherapy. It´s an invasive technique simulation.


Locations(1)

Physioterapy and Pain center research

Alcalá de Henares, Madrid, Spain

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NCT05662722


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