NCT05648695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

November 20, 2022

Last Update Submit

April 21, 2023

Conditions

Fibromyalgia

Keywords

physical therapy modalityPainChronic Fatigue DisorderSleep Quality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Functional capacity

    Baseline and up to three weeks

  • Psychosomatic assessment

    Baseline and up to three weeks

  • Sleep assessment (time elapsed between each sleep phase)

    Baseline and up to three weeks

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

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

Device: Placebo Non-invasive Neuromodulation

Interventions

Non-invasive NeuromodulationDEVICE

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.

Non-invasive Neuromodulation
Placebo Non-invasive NeuromodulationDEVICE

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.

Placebo Non-invasive Neuromodulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Signed informed consent
  • In normal condition and mentally competent to participate in the study.
  • Able to complete the study questionnaires.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugo Gómez Garrido

Talavera de la Reina, Toledo, 45600, Spain

Location

Related Publications (4)

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

    PMID: 19962493RESULT

  • 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.

    PMID: 18768089RESULT

  • 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.

    PMID: 27189527RESULT

  • 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.

    PMID: 17350675RESULT

MeSH Terms

Conditions

FibromyalgiaPainFatigue Syndrome, ChronicSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Hugo Gómez Garrido, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 20, 2022

First Posted

December 13, 2022

Study Start

November 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 21, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)