Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

University of Las Palmas de Gran Canaria

Status

Completed

Conditions

Fibromyalgia

Treatments

Device: Non-invasive Neuromodulation

Device: Placebo Non-invasive Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05648695

NESA FIBRO

Details and patient eligibility

About

Fibromyalgia is a chronic condition that causes pain throughout the body, fatigue and other symptoms. Among the most common clinical symptoms are sleep and anxiety disorders. All these symptoms are very disabling and have a negative impact on the quality of life of these people.

There is currently no curative treatment for this pathology and current treatments focus their efforts on reducing the intensity of the symptoms. The current approach is mainly pharmacological, with the possible side effects that this entails.

Full description

The NESA XSIGNAL® device is a non-invasive, low-frequency neuromodulation device that uses microcurrents to restore the electrical balance in the body. This technology is approved as medical equipment and is CE marked (attached in separate files).

This non-invasive neuromodulation equipment is beginning to show promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the quality of life of people with fibromyalgia.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years of age
Diagnosis of Fibromyalgia meeting ACR 1990/20101,2 criteria, made by a physician, documented by a clinical report.
Diagnosis of Fibromyalgia made at least 12 months ago
Stable baseline treatment in the month prior to inclusion in the study
Signed informed consent
In normal condition and mentally competent to participate in the study.
Able to complete the study questionnaires.

Exclusion criteria

Have any of the following contraindications for treatment with NESA XSIGNAL®: pacemakers, internal bleeding, not applying electrodes to skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity.
Failure to sign the informed consent form.
Active chronic inflammatory joint diseases.
Active neurological diseases with central or peripheral nervous system involvement.
Active systemic autoimmune diseases
Psychotic disorders
Active concomitant neoplastic or infectious processes
Medication changes in the month prior to study inclusion or throughout the duration of the study.