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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache
• Intervention / Treatment: Other: percutaneous needle electrolysis; Other: Dry needling; Other: Sham needling

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Álvarez, Prof; Phone Number: +34 673 60 83 11; Email: fisioceano@hotmail.com

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Recruiting
      • Physioterapy and Pain center research
      • Contact: Laura López Pérez, Mrs; Phone Number: +34683378391; Email: info@institutofisioterapiaydolor.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: percutaneous needle electrolysis; It´s an intervention of physiotherapy. It´s an invasive technique.
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.	Other: Dry needling; It´s an intervention of physiotherapy. It´s an invasive technique.
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.	Other: Sham needling; It´s an intervention of physiotherapy. It´s an invasive technique simulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin bioimpedance	It´s a system to acquire bio-electrical and physiological signals (galvanic skin conductance, heart rate variability), and transfer these signals to a computer for processing an analysis.	Change from Baseline up to 30 minutes
Heart rate variability	It´s a system to acquire bio-electrical and physiological signals (galvanic skin conductance, heart rate variability), and transfer these signals to a computer for processing an analysis.	Change from Baseline up to 30 minutes
Numerical Rating Scale	Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain)	Change from Baseline up to three months
Patients global impressions scale:	It´s the Patient reported outcomes counterpart to the Clinical Global Impressions scale. The PGIS are 1-item questionnaire that ask an individual patient to rate the severity of a specific condition (single-state scales) at baseline and or to rate at endpoint the perceived change in is/her condition in response to therapy; in the other hand PGIC measures change in clinical status.	Change from Baseline up to three months
Pittsburg Sleep Quality Index score	Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome	Change from Baseline up to three months

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: Daniel Pecos-Martin, PhD, Alcala University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Dry Needling
• Other Study ID Numbers: CEID/2022/2/028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No