Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT05648695
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05648695
Study Brief:
Protocol Section:
NCT05648695