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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
It´s an intervention of physiotherapy. It´s an invasive technique.
It´s an intervention of physiotherapy. It´s an invasive technique.
It´s an intervention of physiotherapy. It´s an invasive technique simulation.
Physioterapy and Pain center research
Alcalá de Henares, Madrid, Spain
RECRUITINGSkin temperature
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
Time frame: 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.
Time frame: Change from Baseline up to 30 minutes
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Change from Baseline up to three months
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