Neurostimulation Applied to Fibromyalgia

Fibromyalgia Clinical Trial

— NeuroFibro  

Official title:

Neurostimulation Applied to Fibromyalgia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03384888
• Other study ID #: Eliane Araújo de Oliveira
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

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)