Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
- Conditions
- Headache
- Interventions
- Other: Sham needlingOther: percutaneous needle electrolysisOther: Dry needling
- Registration Number
- NCT05662722
- Lead Sponsor
- University of Alcala
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Headache with a frequency of at least one monthly episode.
- Present the "cold nose" and/or "cold patch" pattern
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham group Sham 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. Pecutaneous electrolysis group percutaneous needle electrolysis 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. dry needling group Dry needling 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.
- Primary Outcome Measures
Name Time Method 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.
Skin temperature Change from Baseline up to 30 minutes It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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)
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
Trial Locations
- Locations (1)
Physioterapy and Pain center research
🇪🇸Alcalá de Henares, Madrid, Spain