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

Headache Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662722
• Other study ID #: CEID/2022/2/028
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: University of Alcala
• Contact: David Álvarez, Prof
• Phone: +34 673 60 83 11
• Email: fisioceano[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Physioterapy and Pain center research	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin temperature	It´s a camera to take infrared thermal images. The images provide facial temperature measurement.	Change from Baseline up to 30 minutes
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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