Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
ConditionHeadache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alcala
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Headache with a frequency of at least one monthly episode.
Present the "cold nose" and/or "cold patch" pattern
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
percutaneous needle electrolysis
Other interventionIt´s an intervention of physiotherapy. It´s an invasive technique.
Dry needling
Other interventionIt´s an intervention of physiotherapy. It´s an invasive technique.
Sham needling
Other interventionIt´s an intervention of physiotherapy. It´s an invasive technique simulation.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Pecutaneous electrolysis groupExperimental treatment 1 intervention
Group B: dry needling groupOther 1 intervention
Group C: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Skin temperature
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
Time frame
Change from Baseline up to 30 minutes2
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 minutesSecondary outcomes
1
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 minutes2
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 minutes3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov