Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

NCT ID: NCT05648695

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-21

Brief Summary

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

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Non-invasive Neuromodulation

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Group Type: EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type: 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

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.

Group Type: PLACEBO_COMPARATOR

Placebo Non-invasive Neuromodulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: collaborator

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: lead

Responsible Party

Aníbal Báez Suárez

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hugo Gómez Garrido, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Locations

Hugo Gómez Garrido

Talavera de la Reina, Toledo, Spain

Countries

Spain

References

Bradley LA. Pathophysiology of fibromyalgia. Am J Med. 2009 Dec;122(12 Suppl):S22-30. doi: 10.1016/j.amjmed.2009.09.008.

Reference Type: RESULT

PMID: 19962493 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18768089 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27189527 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17350675 (View on PubMed)

Other Identifiers

NESA FIBRO

Identifier Type: -

Identifier Source: org_study_id