Neurostimulation Applied to Fibromyalgia (NeuroFibro)

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

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraíba
    • João Pessoa, Paraíba, Brazil, 58.051-900
      • Universidade Federal da Paraíba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life level	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.	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Health assessment level	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.	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Sleep quality	Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cognitive function	Changes in the cognitive function assessed by Mini Mental State Examination.	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Anxiety level	Changes in the anxiety level assessed by Beck Anxiety Inventory	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Depression level	Changes in the depression level assessed by Beck Depression Inventory	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Cortical electrical activity	Changes in the cortical electrical activity assessed by electroencephalogram	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Resilience	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.	Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 20, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Fibromyalgia, Neurostimulation, TDCS
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Eliane Araújo de Oliveira

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No