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

Condition(s) studied

Investigational drug(s) / intervention(s)

percutaneous needle electrolysis: It´s an intervention of physiotherapy. It´s an invasive technique.

Dry needling: It´s an intervention of physiotherapy. It´s an invasive technique.

Sham needling: It´s an intervention of physiotherapy. It´s an invasive technique simulation.

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.

Eligibility

Primary outcome measure(s)

• Skin temperature — Change from Baseline up to 30 minutes
  It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
• Headache Impact Test (HIT-6) — Change from Baseline up to 30 minutes
  Headache Impact (HIT) is a tool used to measure the impact headaches have on your ability to function at work, home, school and in social situations. Your score shows you the effect that headaches they have in normal daily life and in their ability to function.A score of 60 or higher is associated with a very severe impact. A score equal to or less than 49 is associated with a low impact.

Trial sites (1)

More University of Alcala trials in Spain

Other trials for the same condition