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

Официальное название

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

Обзор

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.

Вмешательства

• Другое percutaneous needle electrolysis
  It´s an intervention of physiotherapy. It´s an invasive technique.
• Другое Dry needling
  It´s an intervention of physiotherapy. It´s an invasive technique.
• Другое Sham needling
  It´s an intervention of physiotherapy. It´s an invasive technique simulation.

Первичные конечные точки

• Skin temperature [Срок оценки: Change from Baseline up to 30 minutes]
• Headache Impact Test (HIT-6) [Срок оценки: Change from Baseline up to 30 minutes]

Вторичные конечные точки (5)

• Skin bioimpedance [Срок оценки: Change from Baseline up to 30 minutes]
• Heart rate variability [Срок оценки: Change from Baseline up to 30 minutes]
• Numerical Rating Scale [Срок оценки: Change from Baseline up to three months]
• Patients global impressions scale: [Срок оценки: Change from Baseline up to three months]
• Pittsburg Sleep Quality Index score [Срок оценки: Change from Baseline up to three months]

Критерии участия

Критерии включения

• Headache with a frequency of at least one monthly episode.
• Present the "cold nose" and/or "cold patch" pattern

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Physioterapy and Pain center research — Alcalá de Henares

Идентификаторы

NCT: NCT05662722 · CEID/2022/2/028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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