HeadacheNCT05662722
Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
A study testing percutaneous needle electrolysis and Dry needling in people with Headache, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Headache
- What is being tested?
- percutaneous needle electrolysis and Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 22 Mar 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Headache with a frequency of at least one monthly episode.
- Present the "cold nose" and/or "cold patch" pattern
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Physioterapy and Pain center research
Alcalá de Henares, Madrid, 28805
Laura López Pérez, Mrs, +34683378391, info@institutofisioterapiaydolor.es
About this study
Official title: 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
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.
- Conditions
- Headache
- Being tested
- percutaneous needle electrolysis, Dry needling, Sham needling
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous needle electrolysisOther
It´s an intervention of physiotherapy. It´s an invasive technique.
Dry needlingOther
It´s an intervention of physiotherapy. It´s an invasive technique.
Sham needlingOther
It´s an intervention of physiotherapy. It´s an invasive technique simulation.
| Study group | Role | What they receive |
|---|---|---|
| Pecutaneous electrolysis group | Experimental | 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. Receives: Other: percutaneous needle electrolysis |
| dry needling group | Other | 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. Receives: Other: Dry needling |
| Sham group | Sham comparator | 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. Receives: Other: Sham needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
It´s a camera to take infrared thermal images. The images provide facial temperature measurement.
Measured: 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.
Measured: Change from Baseline up to 30 minutes
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: Change from Baseline up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start22 Mar 2022
- Primary completion26 Sep 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical random assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662722
- Sponsor's protocol ID
- CEID/2022/2/028
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05662722
- Acronym / sponsor ID
- CEID/2022/2/028
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- clinical random assignment
| Arm | Type | Receives |
|---|---|---|
| Pecutaneous electrolysis group | Experimental | Other: percutaneous needle electrolysisSubjects 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 | Other | Other: Dry needlingSubjects 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. |
| Sham group | Sham comparator | Other: Sham needlingSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Headache with a frequency of at least one monthly episode.
- Present the "cold nose" and/or "cold patch" pattern
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous needle electrolysisIt´s an intervention of physiotherapy. It´s an invasive technique. | Other | Pecutaneous electrolysis group |
| Dry needlingIt´s an intervention of physiotherapy. It´s an invasive technique. | Other | dry needling group |
| Sham needlingIt´s an intervention of physiotherapy. It´s an invasive technique simulation. | Other | Sham group |
Primary outcome
Skin temperature
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Skin bioimpedance
Time frame: Change from Baseline up to 30 minutes
Heart rate variability
Time frame: Change from Baseline up to 30 minutes
Numerical Rating Scale
Time frame: Change from Baseline up to three months
Patients global impressions scale:
Time frame: Change from Baseline up to three months
Pittsburg Sleep Quality Index score
Time frame: Change from Baseline up to three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Pecos-Martin, PhD principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous needle electrolysis and Dry needling in people with Headache, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Álvarez, Prof (+34 673 60 83 11, fisioceano@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature (time frame: Change from Baseline up to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.