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

University of Alcala

Status: Enrolling

Conditions: Headache

Treatments: Other: Dry needling; Other: percutaneous needle electrolysis; Other: Sham needling

Study type: Interventional

Funder types: Other

Identifiers

NCT05662722

CEID/2022/2/028

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Pecutaneous electrolysis group

Experimental group

Description:

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.

Treatment:

Other: percutaneous needle electrolysis

dry needling group

Other group

Description:

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.

Treatment:

Other: Dry needling

Sham group

Sham Comparator group

Description:

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.

Treatment:

Other: Sham needling