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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Headache

Intervention / Treatment
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* Other: percutaneous needle electrolysis
* Other: Dry needling
* Other: Sham needling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical random assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pecutaneous electrolysis group<br>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<br>* It´s an intervention of physiotherapy. It´s an invasive technique.<br>|
| Other: dry needling group<br>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<br>* It´s an intervention of physiotherapy. It´s an invasive technique.<br>|
| Sham Comparator: Sham group<br>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<br>* It´s an intervention of physiotherapy. It´s an invasive technique simulation.<br>|

What is the study measuring?
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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 |