Neurostimulation Applied to Fibromyalgia

Federal University of Paraíba59 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Fibromyalgia

Interventions

Active tDCSDEVICE

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.

Sham tDCSDEVICE

Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universidade Federal da Paraiba

João Pessoa, Paraíba, Brazil

Outcomes

Primary Outcomes

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.

Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

Sleep quality

Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.