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

Sponsor

University of Alcala (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05662722

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Headache	Other: percutaneous needle electrolysis Other: Dry needling Other: Sham needling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

clinical random assignmentclinical random assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

triple (care provider, evaluator and outcome assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 26, 2022

Anticipated Primary Completion Date :

Apr 26, 2023

Anticipated Study Completion Date :

Dec 26, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Skin temperature [Change from Baseline up to 30 minutes]
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
Headache Impact Test (HIT-6) [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 Outcome Measures

Skin bioimpedance [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.
Heart rate variability [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.
Numerical Rating Scale [Change from Baseline up to three months]
Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain)
Patients global impressions scale: [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.
Pittsburg Sleep Quality Index score [Change from Baseline up to three months]
Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physioterapy and Pain center research	Alcalá de Henares	Madrid	Spain	28805

Sponsors and Collaborators

University of Alcala

Investigators

Principal Investigator: Daniel Pecos-Martin, PhD, Alcala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Daniel Pecos Martín, Principal Investigator, University of Alcala

ClinicalTrials.gov Identifier:

NCT05662722

Other Study ID Numbers:

CEID/2022/2/028

First Posted:

Dec 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Headache

Study Results

No Results Posted as of Dec 22, 2022