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Neurostimulation Applied to Fibromyalgia (NeuroFibro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384888
Recruitment Status : Active, not recruiting
First Posted : December 28, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Géssika Araújo de Melo, Federal University of Paraíba

Brief Summary:
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Active tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Neurostimulation Applied to Fibromyalgia
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: ano-M1-cat-SO5 tDCS
Participants will receive active transcranial direct current stimulation (tDCS) (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 5 consecutive days.
Device: Active tDCS
Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.
Other Name: Transcranial direct current stimulation

Experimental: ano-M1-cat-SO10 tDCS
Participants will receive active transcranial direct current stimulation (active tDCS). The electrodes will be placed on left M1 for anodic stimulation and on the right supraorbital region for cathodic stimulation on 10 consecutive days.
Device: Active tDCS
Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.
Other Name: Transcranial direct current stimulation

Sham Comparator: Sham tDCS
Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.
Device: Sham tDCS
Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
Other Name: Transcranial direct current stimulation




Primary Outcome Measures :
  1. Pain intensity level [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in pain level, assessed by the Visual Analog Scale, ranges from 0 - 10, with 10 being the highest level of pain.


Secondary Outcome Measures :
  1. Quality of life level [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in quality of life level assessed by Fibromyalgia Impact Questionnaire (FIQ). The FIQ is composed of 19 questions, which measure functional capacity, work status, psychological disturbances, physical and painful symptoms. The greater the impact of the disease, the greater the score found. The FIQ consists of 10 items. The first item contains 10 questions ("a" through "j") related to physical functioning - each issue is evaluated on a four-point Likert scale. In items 2 and 3, the patient is asked to mark the number of days he felt well and the number of days that were unable to work (including housework) because of fibromyalgia-related symptoms. Items 4 to 10 are horizontal lines of 10 cm in length (Visual Analog Scale), in which the patient measures the difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression.

  2. Health assessment level [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in health assessed level assessed by Fibromyalgia Health Assessment (HAQ). It has eight categories: clothing and physical presence, wake up, feed, walk, hygiene, reach, footprint and other daily activities. For each of these categories, the patient indicates the degree of difficulty in four possible responses ranging from "no difficulty = 0" to "unable to do it = 3". The score for each category appears in the highest number of any of your items. The final HAQ score is the average of the scores of the eight categories and the higher the final score the worse the test result. Questionaire.

  3. Sleep quality [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.

  4. Cognitive function [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the cognitive function assessed by Mini Mental State Examination.

  5. Anxiety level [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the anxiety level assessed by Beck Anxiety Inventory

  6. Depression level [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the depression level assessed by Beck Depression Inventory

  7. Cortical electrical activity [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the cortical electrical activity assessed by electroencephalogram

  8. Resilience [ Time Frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) ]
    Changes in the resilience assessed by Wagnild and Young Resilience Scale. It has 25 items described positively with likert type response ranging from 1 (totally disagree) to 7 (totally agree). Scale scores range from 25 to 175 points, with high values indicating high resilience.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
  • (2) been diagnosed for at least three months;
  • (3) be female;
  • (4) be in the age group between 25 and 60 years of age; and
  • (5) sign the consent form.

Exclusion Criteria:

  • (1) cognitive deficit, evaluated through the Mini Mental State Examination (MMSE);
  • (2) illiterate;
  • (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker;
  • (4) history of convulsion;
  • (5) severe depression, measured by score greater than 36 on Beck Depression Inventory; and
  • (6) be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384888


Locations
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Brazil
Universidade Federal da Paraiba
João Pessoa, Paraíba, Brazil, 58.051-900
Sponsors and Collaborators
Federal University of Paraíba
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Responsible Party: Géssika Araújo de Melo, Eliane Araújo de Oliveira, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT03384888    
Other Study ID Numbers: Eliane Araújo de Oliveira
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Géssika Araújo de Melo, Federal University of Paraíba:
Fibromyalgia, Neurostimulation, TDCS
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases