Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Non-invasive Neuromodulation
* Device: Placebo Non-invasive Neuromodulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive Neuromodulation<br>Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. | Device: Non-invasive Neuromodulation<br>* 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.<br>|
| Placebo Comparator: Placebo Non-invasive Neuromodulation<br>Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7. | Device: Placebo Non-invasive Neuromodulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain assessed by VAS | 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. | Baseline and up to three weeks | 
| Change in Sleep quality | 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. | Baseline and up to three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | 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). | Baseline and up to three weeks | 
| Psychosomatic assessment | 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. | Baseline and up to three weeks | 
| Sleep assessment (time elapsed between each sleep phase) | 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. | Baseline and up to three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy modality, Pain, Chronic Fatigue Disorder, Sleep Quality