Effects of neuromodulation in women with fibromyalgia
Phase 1
Recruiting
- Conditions
- FibromyalgiaM79.7
- Registration Number
- RBR-6w2vtp
- Lead Sponsor
- niversidade Federal da Paraíba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Have a diagnosis of fibromyalgia according to the criteria of the American College of Reumathology; Having been diagnosed at least three months ago; Being female; Be in the age group between 35 and 60 years old; Present a pain level above four on the visual analog scale; Sign the Free and Informed Consent Form.
Exclusion Criteria
Score below 24 on the Mini Mental State Examination; illiterate; have metallic implants located on the head or cochlear implants or cardiac pacemaker; being pregnant; have a history of seizure.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity, assessed by visual analog scale. The scale consists of a horizontal line of 10 cm, in which there are graduations ranging from zero to 10, and the participants point out a point that for them best represents their perception of pain intensity, with (0) being in absence of pain, (1-3) mild, (4-7) moderate and (8-10) severe pain.
- Secondary Outcome Measures
Name Time Method Cortical electrical activity, assessed by electroencephalogram (EEG).<br>The EEG used has 32 channels, with silver chloride electrodes, which will be fixed to the scalp through an adjustable cap. The amplifier is the ActiChamp, developed by Brain Products Inc., with a sampling rate of 500Hz.