Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dry Needling for Cervicogenic Headache

NCT05140291

Headache

UNKNOWN NA

Peri-neural Electrical Dry Needling Migraine Treatment Study

NCT04252391

Migraine Headache

UNKNOWN NA

Treatment of Headache Disorders With Acupuncture: Observational Study: OBSERVATIONAL STUDY (HDACU)

NCT03250754

Chronic Headache Disorder

COMPLETED

Effectiveness of the Dry Needling Approach in Patients With Tension-Type Headache

NCT06108180

Tension-Type Headache Dry Needling

COMPLETED NA

Dry Needling of the M. Obliquus Capitis Inferior on Rotational Mobility and Headache Related Outcome Measures in CH.

NCT05074381

Neck Pain, Posterior Headache Mobility Limitation

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

clinical random assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

triple (care provider, evaluator and outcome assessor)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pecutaneous electrolysis group

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.

Group Type EXPERIMENTAL

percutaneous needle electrolysis

Intervention Type OTHER

It´s an intervention of physiotherapy. It´s an invasive technique.

dry needling group

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.

Group Type OTHER

Dry needling

Intervention Type OTHER

It´s an intervention of physiotherapy. It´s an invasive technique.

Sham group

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.

Group Type SHAM_COMPARATOR

Sham needling

Intervention Type OTHER

It´s an intervention of physiotherapy. It´s an invasive technique simulation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.