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

Sponsor
University of Alcala
Study ID
NCT05662722
Status
Recruiting
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Conditions

  • Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • percutaneous needle electrolysis — OTHER
    It´s an intervention of physiotherapy. It´s an invasive technique.
  • Dry needling — OTHER
    It´s an intervention of physiotherapy. It´s an invasive technique.
  • Sham needling — OTHER
    It´s an intervention of physiotherapy. It´s an invasive technique simulation.

Study Details

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.

Key Dates

First listed
Dec 22, 2022
Start date
Mar 22, 2022
Status verified
Apr 2026
Primary completion
Sep 26, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pecutaneous electrolysis group
    Subjects were treated twice (one day and one week). The technique consisted in the application of a galvanic electrical current using a needle as an electrode that will be inserted into the concha of the ear. The subjects were lying in supinus.
  • Other: dry needling group
    Subjects were treated twice (one day and one week). The technique consisted in the puncture with a needle in the concha of the ear. The subjects were lying in supinus.
  • Sham Comparator: Sham group
    Subjects were treated twice (one day and one week). The technique consisted in the puncture with a sham-needle in the concha of the ear. The subjects were lying in supinus.

Primary Outcome Measure

Skin temperature [ Time Frame: Change from Baseline up to 30 minutes ]

Central Contacts

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