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NCT Number: NCT05662722

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

Location status: Recruiting

Location contact

Laura López Pérez, Mrs

CONTACT

[email protected]

+34683378391

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Skin temperature

    Time frame: Change from Baseline up to 30 minutes

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

  2. Headache Impact Test (HIT-6)

    Time frame: 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.

Secondary outcomes

  1. Skin bioimpedance

    Time frame: Change from Baseline up to 30 minutes

    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.

  2. Heart rate variability

    Time frame: Change from Baseline up to 30 minutes

    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.

  3. Numerical Rating Scale

    Time frame: Change from Baseline up to three months

    Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain)

  4. Patients global impressions scale:

    Time frame: Change from Baseline up to three months

    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.

  5. Pittsburg Sleep Quality Index score

    Time frame: Change from Baseline up to three months

    Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

David Álvarez, Prof

CONTACT

[email protected]

+34 673 60 83 11

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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