Transcranial direct current stimulation (tDCS) in patients with painful diabetic polyneuropathy: protocol for a randomized clinical trial.
Brain Stimulation, tDCS, Diabetics, Chronic pain.
Introduction: Diabetes mellitus is a disease that has high prevalence rates worldwide, especially in Brazil, where 16% of patients are affected by painful diabetic polyneuropathy, and current treatments are mainly based on pharmacological interventions. Transcranial direct current stimulation (tDCS) is a technique that promotes brain neuromodulation, inducing changes in the excitability of the human cortex, promoting physiological effects that extend to physical and behavioral aspects. Thus, it may be a potential treatment for the treatment of chronic pain in this population. Objective: The primary objective of this study is to analyze the effects of tDCS application on pain in patients with painful diabetic polyneuropathy. Methodology: This is a protocol of a randomized controlled, double-blind, 2-arm clinical trial, with the participation of individuals of both sexes, aged 30 to 69 years, with a total of 36 participants divided into a group active and a sham group. A total of five consecutive sessions will be administered, one session per day, lasting 20 minutes through a current with an intensity of 2 mA, using tDCS applied to the primary motor cortex (C3/Fp2 assembly). All participants will be evaluated for pain, functionality, quality of life, muscle strength and sleep at baseline, immediately after the 5th session and 30 days after the intervention. Expected results: The application of tDCS in the setup suggested in the protocol is already recommended for painful syndromes, thus, it is expected the improvement of the variables studied in the active group, strengthening the use of the resource as a form of treatment for this population. Therefore, tDCS could be used as a non-pharmacological alternative method for the treatment of painful diabetic polyneuropathy.