Headache
Conditions
Brief summary
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
It´s an intervention of physiotherapy. It´s an invasive technique.
OTHERDry needling
It´s an intervention of physiotherapy. It´s an invasive technique.
OTHERSham needling
It´s an intervention of physiotherapy. It´s an invasive technique simulation.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
triple (care provider, evaluator and outcome assessor)
Intervention model description
clinical random assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature | Change from Baseline up to 30 minutes | It´s a camera to take infrared thermal images. The images provide facial temperature measurement. |
| Headache Impact Test (HIT-6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin bioimpedance | Change from Baseline up to 30 minutes | 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. |
| Heart rate variability | Change from Baseline up to 30 minutes | 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. |
| Numerical Rating Scale | Change from Baseline up to three months | Patients vebally requested to rate their pain: "Rate your pain from = (no pain) to 10 (unbearable pain) |
| Patients global impressions scale: | Change from Baseline up to three months | 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. |
| Pittsburg Sleep Quality Index score | Change from Baseline up to three months | Improvement in Pittsburg Sleep Quality Index (PSQI), Scale is 0 to 21, higher score is worse outcome |
Countries
Spain
Contacts
CONTACTDavid Álvarez, Prof
PRINCIPAL_INVESTIGATORDaniel Pecos-Martin, PhD
Alcala University
Outcome results
None listed