Fibromyalgia
Conditions
Keywords
Fibromyalgia, Neurostimulation, TDCS
Brief summary
NeuroFibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.
Interventions
DEVICEActive 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.
DEVICESham tDCS
Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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).
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Depression level | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | Changes in the depression level assessed by Beck Depression Inventory |
| Cortical electrical activity | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | Changes in the cortical electrical activity assessed by electroencephalogram |
| 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. |
| Anxiety level | Baseline (week 1); Endpoint (week 2 or 3 depending on the arm) | Changes in the anxiety level assessed by Beck Anxiety Inventory |
Countries
Brazil
Outcome results
None listed