Skip to main content
OpenTrials
Completed

NCT Number: NCT05648695

Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Chronic Disease Disease Attributes Dyssomnias Encephalomyelitis Fatigue Syndrome, Chronic Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hugo Gómez Garrido

Talavera de la Reina, Toledo, 45600, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Neuromodulation

Device

The electrodes will be placed with the help of gloves and adapted socks for 1 hour, each session, until 13 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.

Placebo Non-invasive Neuromodulation

Device

The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Primary outcomes

  1. Change in Pain assessed by VAS

    Time frame: Baseline and up to three weeks

    The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS).

    Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".

  2. Change in Sleep quality

    Time frame: Baseline and up to three weeks

    The Pittsburgh Sleep Quality Index (PSQI) will be used. It consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score.

    The higher the total score, the worse the sleep quality. Thus, a total score less than or equal to five on the Pittsburgh scale indicates that, in general, your sleep quality is optimal, while a total score greater than five suggests that you have sleep problems, of greater or lesser severity.

Secondary outcomes

  1. Functional capacity

    Time frame: Baseline and up to three weeks

    The fibromyalgia impact questionnaire (FIQ) will be used. It assesses the impact on health in terms of physical capacity, the ability to carry out usual work and, in the case of paid work, the degree to which fibromyalgia has affected this activity as well as subjective items closely related to this pathology (pain, fatigue, feeling of tiredness).

  2. Psychosomatic assessment

    Time frame: Baseline and up to three weeks

    The Brief Symptom Checklist (LSB-50) will be used. It is a clinical instrument for the identification and assessment of psychological and psychosomatic symptoms in adults. It has been developed from the authors' experience with other symptom measurement questionnaires.

    The questionnaire is composed of 7 main scales (Obsessive Sensitivity, Anxiety, Hostility, Somatisation, Depression, Strict Sleep and Extended Sleep); 2 subscales (Sensitivity and Obsessive-Compulsion) and 1 Psychopathological Risk scale. It allows 3 global indices to be obtained (Global Severity Index, Number of Positive Symptoms and Positive Symptom Intensity Index), each of which is indicative of different aspects of general psychopathological distress.

  3. Sleep assessment (time elapsed between each sleep phase)

    Time frame: Baseline and up to three weeks

    Using the polysomnography technique, the duration of the different phases of sleep will be evaluated.

    Polysomnography is a non-invasive and painless test that allows the study of sleep, its phases (REM and non-REM) and also its various alterations. In order to recognise which phase of sleep the patient is in, and to quantify the time that elapses during the phase, polysomnography simultaneously performs an electroencephalogram (EEG), detects muscle activity with a surface electromyogram, usually submental (EMG), eye movements with an electrooculogram (EOG) and body position using sensors on the limbs.

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Collaborators

  • University of Castilla-La Mancha

Registry information

Official study title

Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia: a Randomised, Triple-blind Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.