Back to resultsEfficacy of Non-invasive NESA Neuromodulation in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-invasive Neuromodulation
Placebo Non-invasive Neuromodulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring physical therapy modality, Pain, Chronic Fatigue Disorder, Sleep Quality
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.
Sites / Locations
- Hugo Gómez Garrido
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Non-invasive Neuromodulation
Placebo Non-invasive Neuromodulation
Arm Description
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Outcomes
Primary Outcome Measures
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".
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.
Secondary Outcome Measures
Functional capacity
The fibromyalgia impact questionnaire (FIQ) will be used. It assesses the impact on health in terms of physical capacity, the ability to carry out usual work and, in the case of paid work, the degree to which fibromyalgia has affected this activity as well as subjective items closely related to this pathology (pain, fatigue, feeling of tiredness).
Psychosomatic assessment
The Brief Symptom Checklist (LSB-50) will be used. It is a clinical instrument for the identification and assessment of psychological and psychosomatic symptoms in adults. It has been developed from the authors' experience with other symptom measurement questionnaires.
The questionnaire is composed of 7 main scales (Obsessive Sensitivity, Anxiety, Hostility, Somatisation, Depression, Strict Sleep and Extended Sleep); 2 subscales (Sensitivity and Obsessive-Compulsion) and 1 Psychopathological Risk scale. It allows 3 global indices to be obtained (Global Severity Index, Number of Positive Symptoms and Positive Symptom Intensity Index), each of which is indicative of different aspects of general psychopathological distress.
Sleep assessment (time elapsed between each sleep phase)
Using the polysomnography technique, the duration of the different phases of sleep will be evaluated.
Polysomnography is a non-invasive and painless test that allows the study of sleep, its phases (REM and non-REM) and also its various alterations. In order to recognise which phase of sleep the patient is in, and to quantify the time that elapses during the phase, polysomnography simultaneously performs an electroencephalogram (EEG), detects muscle activity with a surface electromyogram, usually submental (EMG), eye movements with an electrooculogram (EOG) and body position using sensors on the limbs.
Full Information
NCT ID
NCT05648695
First Posted
November 20, 2022
Last Updated
April 21, 2023
Sponsor
University of Las Palmas de Gran Canaria
Collaborators
University of Castilla-La Mancha
1. Study Identification
Unique Protocol Identification Number
NCT05648695
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Las Palmas de Gran Canaria
Collaborators
University of Castilla-La Mancha
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
physical therapy modality, Pain, Chronic Fatigue Disorder, Sleep Quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive Neuromodulation
Arm Type
Experimental
Arm Description
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Arm Title
Placebo Non-invasive Neuromodulation
Arm Type
Placebo Comparator
Arm Description
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Intervention Type
Device
Intervention Name(s)
Non-invasive Neuromodulation
Intervention Description
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
Intervention Name(s)
Placebo Non-invasive Neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain assessed by VAS
Description
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".
Time Frame
Baseline and up to three weeks
Title
Change in Sleep quality
Description
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.
Time Frame
Baseline and up to three weeks
Secondary Outcome Measure Information:
Title
Functional capacity
Description
The fibromyalgia impact questionnaire (FIQ) will be used. It assesses the impact on health in terms of physical capacity, the ability to carry out usual work and, in the case of paid work, the degree to which fibromyalgia has affected this activity as well as subjective items closely related to this pathology (pain, fatigue, feeling of tiredness).
Time Frame
Baseline and up to three weeks
Title
Psychosomatic assessment
Description
The Brief Symptom Checklist (LSB-50) will be used. It is a clinical instrument for the identification and assessment of psychological and psychosomatic symptoms in adults. It has been developed from the authors' experience with other symptom measurement questionnaires.
The questionnaire is composed of 7 main scales (Obsessive Sensitivity, Anxiety, Hostility, Somatisation, Depression, Strict Sleep and Extended Sleep); 2 subscales (Sensitivity and Obsessive-Compulsion) and 1 Psychopathological Risk scale. It allows 3 global indices to be obtained (Global Severity Index, Number of Positive Symptoms and Positive Symptom Intensity Index), each of which is indicative of different aspects of general psychopathological distress.
Time Frame
Baseline and up to three weeks
Title
Sleep assessment (time elapsed between each sleep phase)
Description
Using the polysomnography technique, the duration of the different phases of sleep will be evaluated.
Polysomnography is a non-invasive and painless test that allows the study of sleep, its phases (REM and non-REM) and also its various alterations. In order to recognise which phase of sleep the patient is in, and to quantify the time that elapses during the phase, polysomnography simultaneously performs an electroencephalogram (EEG), detects muscle activity with a surface electromyogram, usually submental (EMG), eye movements with an electrooculogram (EOG) and body position using sensors on the limbs.
Time Frame
Baseline and up to three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Gómez Garrido, PhD
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hugo Gómez Garrido
City
Talavera de la Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19962493
Citation
Bradley LA. Pathophysiology of fibromyalgia. Am J Med. 2009 Dec;122(12 Suppl):S22-30. doi: 10.1016/j.amjmed.2009.09.008.
Results Reference
result
PubMed Identifier
18768089
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.
Results Reference
result
PubMed Identifier
27189527
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.
Results Reference
result
PubMed Identifier
17350675
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.
Results Reference
result
Learn more about this trial
Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia
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