Using needle electrolysis on the ear to treat headaches
Use of Infrared Thermography in the Measurement of Facial Blood Flow After the Application of Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
NA · University of Alcala · NCT05662722
This study is testing if a new treatment using tiny needles on the ear can help reduce headaches and improve symptoms for people who suffer from them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Alcala (other) |
| Locations | 1 site (Alcalá de Henares, Madrid) |
| Trial ID | NCT05662722 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of percutaneous needle electrolysis on the concha of the ear to treat headaches. The approach involves stimulating the auricular vagal nerve with galvanic current delivered through a needle electrode, aiming to modulate pain and inflammation associated with headaches. The study will measure outcomes using infrared thermography to assess changes in facial skin temperature, particularly looking for patterns indicative of sympathetic activity. Participants will be monitored for headache frequency and symptom relief throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing headaches at least once a month and exhibiting a 'cold nose' or 'cold patch' pattern.
Not a fit: Patients who do not show the 'cold nose' or 'cold patch' pattern, pregnant women, or those with certain facial conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, non-invasive option for patients suffering from various types of headaches.
How similar studies have performed: While the use of auricular stimulation for headache treatment has been explored, this specific approach using needle electrolysis is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Alcalá de Henares, Madrid
- Physioterapy and Pain center research — Alcalá de Henares, Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Daniel Pecos-Martin, PhD — Alcala University
- Study coordinator: David Álvarez, Prof
- Email: fisioceano@hotmail.com
- Phone: +34 673 60 83 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Headache