Neurostimulation Applied to Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Device: Active tDCS; Device: Sham tDCS

• Registration Number: NCT03384888
• Lead Sponsor: Federal University of Paraíba

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ano-M1-cat-SO10 tDCS	Active 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.
Sham tDCS	Sham tDCS	Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.
ano-M1-cat-SO5 tDCS	Active 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.

Primary Outcome Measures

Name	Time	Method
Pain intensity level	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

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

Trial Locations

Locations (1)

Universidade Federal da Paraiba; 🇧🇷 João Pessoa, Paraíba, Brazil