Clinical trial NCT05648695: Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia
Official title: Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia: a Randomised, Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: physical therapy modality
Pain
Chronic Fatigue Disorder
Sleep Quality
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2022-12-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Pain assessed by VAS
timeFrame: Baseline and up to three weeks
measure: Change in Sleep quality
timeFrame: Baseline and up to three weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: Baseline and up to three weeks
measure: Psychosomatic assessment
timeFrame: Baseline and up to three weeks
measure: Sleep assessment (time elapsed between each sleep phase)
timeFrame: Baseline and up to three weeks
Other outcomes:
Locations:
city: Talavera de la Reina
country: Spain
facility: Hugo Gómez Garrido
state: Toledo
Study officials:
affiliation: University of Castilla-La Mancha
name: Hugo Gómez Garrido, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradley LA. Pathophysiology of fibromyalgia. Am J Med. 2009 Dec;122(12 Suppl):S22-30. doi: 10.1016/j.amjmed.2009.09.008.
citation: 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.
citation: 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.
citation: 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.