Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: percutaneous needle electrolysis, Dry needling, Sham needling.
- Who it may be relevant to
- Registry conditions: Headache. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other percutaneous needle electrolysis
It´s an intervention of physiotherapy. It´s an invasive technique. - Other Dry needling
It´s an intervention of physiotherapy. It´s an invasive technique. - Other Sham needling
It´s an intervention of physiotherapy. It´s an invasive technique simulation.
Primary outcome measures
- Skin temperature [Time frame: Change from Baseline up to 30 minutes]
- Headache Impact Test (HIT-6) [Time frame: Change from Baseline up to 30 minutes]
Secondary outcome measures (5)
- Skin bioimpedance [Time frame: Change from Baseline up to 30 minutes]
- Heart rate variability [Time frame: Change from Baseline up to 30 minutes]
- Numerical Rating Scale [Time frame: Change from Baseline up to three months]
- Patients global impressions scale: [Time frame: Change from Baseline up to three months]
- Pittsburg Sleep Quality Index score [Time frame: Change from Baseline up to three months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Physioterapy and Pain center research — Alcalá de Henares
Identifiers
NCT: NCT05662722 · CEID/2022/2/028