Trials
Search / Trial NCT05648695

Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia

Launched by UNIVERSITY OF LAS PALMAS DE GRAN CANARIA · Dec 11, 2022

Trial Information

Current as of January 14, 2025

Completed

Keywords

Physical Therapy Modality Pain Chronic Fatigue Disorder Sleep Quality

ClinConnect Summary

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.

Gender

ALL

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.

Trial Officials

Hugo Gómez Garrido, PhD

Principal Investigator

University of Castilla-La Mancha

About University Of Las Palmas De Gran Canaria

The University of Las Palmas de Gran Canaria (ULPGC) is a leading academic institution dedicated to advancing knowledge through research and education. With a strong emphasis on innovation and interdisciplinary collaboration, ULPGC actively engages in clinical trials to explore new therapeutic approaches and improve patient outcomes. The university's research initiatives are supported by a diverse team of experts and state-of-the-art facilities, fostering a robust environment for conducting high-quality clinical investigations. Committed to ethical standards and scientific integrity, ULPGC aims to contribute significantly to the fields of healthcare and medical science.

Locations

Talavera De La Reina, Toledo, Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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