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

Primary Purpose

Headache

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
percutaneous needle electrolysis
Dry needling
Sham needling
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Physioterapy and Pain center researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Sham Comparator

Arm Label

Pecutaneous electrolysis group

dry needling group

Sham group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Numerical Rating Scale
Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain)
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.
Pittsburg Sleep Quality Index score
Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome

Full Information

First Posted
December 6, 2022
Last Updated
August 2, 2023
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05662722
Brief Title
Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
November 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical random assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
triple (care provider, evaluator and outcome assessor)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pecutaneous electrolysis group
Arm Type
Experimental
Arm Description
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.
Arm Title
dry needling group
Arm Type
Other
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
percutaneous needle electrolysis
Intervention Description
It´s an intervention of physiotherapy. It´s an invasive technique.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
It´s an intervention of physiotherapy. It´s an invasive technique.
Intervention Type
Other
Intervention Name(s)
Sham needling
Intervention Description
It´s an intervention of physiotherapy. It´s an invasive technique simulation.
Primary Outcome Measure Information:
Title
Skin temperature
Description
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
Time Frame
Change from Baseline up to 30 minutes
Title
Headache Impact Test (HIT-6)
Description
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.
Time Frame
Change from Baseline up to 30 minutes
Secondary Outcome Measure Information:
Title
Skin bioimpedance
Description
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.
Time Frame
Change from Baseline up to 30 minutes
Title
Heart rate variability
Description
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.
Time Frame
Change from Baseline up to 30 minutes
Title
Numerical Rating Scale
Description
Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain)
Time Frame
Change from Baseline up to three months
Title
Patients global impressions scale:
Description
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.
Time Frame
Change from Baseline up to three months
Title
Pittsburg Sleep Quality Index score
Description
Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome
Time Frame
Change from Baseline up to three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Álvarez, Prof
Phone
+34 673 60 83 11
Email
fisioceano@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physioterapy and Pain center research
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura López Pérez, Mrs
Phone
+34683378391
Email
info@institutofisioterapiaydolor.es

12. IPD Sharing Statement

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

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