Neurostimulation Applied to Fibromyalgia

Federal University of Paraíba1 site in 1 country59 target enrollmentMay 15, 2017

Overview

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

Registry

clinicaltrials.gov

Start Date

May 15, 2017

End Date

May 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Federal University of Paraíba

Responsible Party

Principal Investigator

Géssika Araújo de Melo

Eliane Araújo de Oliveira

Federal University of Paraíba

•(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.

•(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.

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.

Quality of life level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Anxiety level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Depression level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Cognitive function(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Cortical electrical activity(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Health assessment level(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Sleep quality(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))
Resilience(Baseline (week 1); Endpoint (week 2 or 3 depending on the arm))