Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Non-invasive Neuromodulation; Device: Placebo Non-invasive Neuromodulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Talavera de la Reina, Toledo, Spain, 45600
      • Hugo Gómez Garrido

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Las Palmas de Gran Canaria
• Collaborators: University of Castilla-La Mancha
• Investigators: Principal Investigator: Hugo Gómez Garrido, PhD, University of Castilla-La Mancha

Publications and helpful links

General Publications

• Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
• Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.
• Bradley LA. Pathophysiology of fibromyalgia. Am J Med. 2009 Dec;122(12 Suppl):S22-30. doi: 10.1016/j.amjmed.2009.09.008.
• Dadabhoy D, Crofford LJ, Spaeth M, Russell IJ, Clauw DJ. Biology and therapy of fibromyalgia. Evidence-based biomarkers for fibromyalgia syndrome. Arthritis Res Ther. 2008;10(4):211. doi: 10.1186/ar2443. Epub 2008 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Sleep Quality; physical therapy modality; Chronic Fatigue Disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: NESA FIBRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No