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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Headache Impact Test (HIT-6)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
triple (care provider, evaluator and outcome assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Headache with a frequency of at least one monthly episode.
- •Present the "cold nose" and/or "cold patch" pattern
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sham needling (Other)
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.
干预措施: percutaneous needle electrolysis (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.
干预措施: Dry needling (Other)
结局指标
主要结局
Headache Impact Test (HIT-6)
时间窗: 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.
Skin temperature
时间窗: Change from Baseline up to 30 minutes
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
次要结局
- Heart rate variability(Change from Baseline up to 30 minutes)
- Patients global impressions scale:(Change from Baseline up to three months)
- Skin bioimpedance(Change from Baseline up to 30 minutes)
- Numerical Rating Scale(Change from Baseline up to three months)
- Pittsburg Sleep Quality Index score(Change from Baseline up to three months)
研究者
Prof. Dr. Daniel Pecos Martín
Principal Investigator
University of Alcala