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Neurostimulation Applied to Fibromyalgia (NeuroFibro)

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Neurostimulation, TDCS

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal da Paraiba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

ano-M1-cat-SO5 tDCS

ano-M1-cat-SO10 tDCS

Sham tDCS

Arm Description

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.

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.

Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Sleep quality
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.
Cognitive function
Changes in the cognitive function assessed by Mini Mental State Examination.
Anxiety level
Changes in the anxiety level assessed by Beck Anxiety Inventory
Depression level
Changes in the depression level assessed by Beck Depression Inventory
Cortical electrical activity
Changes in the cortical electrical activity assessed by electroencephalogram
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.

Full Information

First Posted
December 20, 2017
Last Updated
January 20, 2019
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT03384888
Brief Title
Neurostimulation Applied to Fibromyalgia
Acronym
NeuroFibro
Official Title
Neurostimulation Applied to Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Neurostimulation, TDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The parallel clinical trial simultaneously compares two groups of individuals, one of which receives the intervention of interest and the other is a control group (sham).
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ano-M1-cat-SO5 tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
ano-M1-cat-SO10 tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants who receive stimulation of the simulated type (sham tDCS), following the protocol of the ano-M1-cat-SO5 group.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
Primary Outcome Measure Information:
Title
Pain intensity level
Description
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 Outcome Measure Information:
Title
Quality of life level
Description
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)
Title
Health assessment level
Description
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)
Title
Sleep quality
Description
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index.
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Title
Cognitive function
Description
Changes in the cognitive function assessed by Mini Mental State Examination.
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Title
Anxiety level
Description
Changes in the anxiety level assessed by Beck Anxiety Inventory
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Title
Depression level
Description
Changes in the depression level assessed by Beck Depression Inventory
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Title
Cortical electrical activity
Description
Changes in the cortical electrical activity assessed by electroencephalogram
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)
Title
Resilience
Description
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.
Time Frame
Baseline (week 1); Endpoint (week 2 or 3 depending on the arm)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal da Paraiba
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58.051-900
Country
Brazil

12. IPD Sharing Statement

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Neurostimulation Applied to Fibromyalgia

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