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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03384888
Other study ID # Eliane Araújo de Oliveira
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date May 2020

Study information

Verified date January 2019
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 59
Est. completion date May 2020
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Universidade Federal da Paraiba João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary Sleep quality Changes in sleep quality assessed by Pittsburgh Sleep Quality Index. Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary 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)
Secondary Anxiety level Changes in the anxiety level assessed by Beck Anxiety Inventory Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary Depression level Changes in the depression level assessed by Beck Depression Inventory Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary Cortical electrical activity Changes in the cortical electrical activity assessed by electroencephalogram Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Secondary 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)
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