An interventional study of percutaneous needle electrolysis and Dry needling in Headache, sponsored by University of Alcala. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Alcala · Not applicable, Interventional, and Treatment
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 560 interventional studies indexed under Headache.
Browse Headache studies →University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: percutaneous needle electrolysis
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.
Other: Dry needling
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.
Other: Sham needling
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.
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 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
Started Mar 2022 (actual). Primary completion is estimated for Sep 2026, 54 months after the start.
Of 175 non-industry interventional studies with no phase under Headache, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 54 months is above that.
Counting every sponsor, half of 193 studies reached it within 14 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.