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

NCT05662722 | Recruiting

• 1 other identifier: CEID/2022/2/028
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Headache

Outcome Measures

Primary Outcomes (2)

• Skin temperature

  It´s a camera to take infrared thermal images. The images provide facial temperature measurement.

  Change from Baseline up to 30 minutes

• Headache Impact Test (HIT-6)

  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.

  Change from Baseline up to 30 minutes

Secondary Outcomes (5)

• Skin bioimpedance

  Change from Baseline up to 30 minutes

• Heart rate variability

  Change from Baseline up to 30 minutes

• Numerical Rating Scale

  Change from Baseline up to three months

• Patients global impressions scale:

  Change from Baseline up to three months

• Pittsburg Sleep Quality Index score

  Change from Baseline up to three months

Study Arms (3)

Pecutaneous electrolysis group

EXPERIMENTAL

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: percutaneous needle electrolysis

dry needling group

OTHER

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.

Other: Dry needling

Sham group

SHAM COMPARATOR

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.

Other: Sham needling

Interventions

percutaneous needle electrolysis OTHER

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

Pecutaneous electrolysis group

Dry needling OTHER

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

dry needling group

Sham needling OTHER

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

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

MeSH Terms

Conditions

Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Daniel Pecos-Martin, PhD

  Alcala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Álvarez, Prof

CONTACT

+34 673 60 83 11; fisioceano@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple (care provider, evaluator and outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: clinical random assignment

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 22, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (1)