Effects of Anodal Transcranial Direct Current Stimulation on the Primary Motor Cortex in Women With Fibromyalgia: A Randomized, Triple-Blind Clinical Trial

Abstract

ObjectivesThe aim of this study was to analyze the effects of ten sessions of active transcranial direct current stimulation transcranial direct current stimulation (tDCS) (2 mA) with 13:20:13 stimulation at M1 in women with fibromyalgia (FM). To the best of our knowledge, this is the first article that uses this protocol in patients with FM. The main hypothesis is that the protocol would be effective in decreasing pain and that the results would last for up to 90 days. Materials and MethodsThis study was a randomized clinical trial with 35 women with FM divided into two groups, active tDCS group and sham tDCS group. A conventional tDCS device was used to deliver 2 mA for 13 minutes, with a 20-minute break followed by a further 13 minutes of stimulation for ten sessions. The anodal stimulus was in the left primary motor cortex M1 region. The primary outcome was a change in the visual analog scale and the Survey of Pain Attitudes pain score at the end of treatment, after 30 days, and 90 days after the end of treatment. Secondary outcomes included changes in the Fibromyalgia Impact Questionnaire, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, World Health Organization's Quality of Life Questionnaire, and Fatigue Assessment Scale. The Research Ethics Committee of the Centro Universitário da Grande Dourados under registration number Certificado de Apresentação de Apreciação Ética approved this research: 36444920.5.0000.5159. The study was registered in The Brazilian Registry of Clinical Trials with the identifier RBR-8wc8rjq. ResultsThe active tDCS group showed improvement in pain after ten sessions (p < 0.001), after 30 days (p < 0.01), and after 90 days (p < 0.001) compared with sham tDCS. In addition, improvement in quality of life (QoL) and fatigue was observed in the active tDCS group. ConclusionThe results of this study suggest that active tDCS with an intensity of 2 mA for ten sessions was effective in decreasing pain and fatigue and improving QoL in patients with FM.