Main Article Content
Background:Chronic Low back pain (LBP) is a prevalent disease associated with significant disability and high costs to society. Although exercise protocols have proven benefit to relief pain symptoms, their effectiveness are often limited. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has shown promising results on reducing pain scores in different conditions. However, there is still weak evidence of its clinical impact on chronic LBP.
Methods:We propose a single-center, randomized, double-blind, placebo-controlled, phase II trial, with parallel design, including 97 patients aged 18-65 years with > 12 weeks of LBP and a baseline pain score of ≥ 3 in theVisual Analogue Scale (VAS).Participants will be randomized by blocks to one of the treatment arms (active-tDCS + exercise or sham-tDCS + exercise), with 4 weeks of intervention. Our main outcome will be pain as assessed by VAS. Secondary outcomes will be: (1) functional disability (Roland Morris Disability Questionnaire); (2) quality of life (SF-36); (3) parameters related to pain mechanisms (endogenous pain inhibition and facilitation, and central sensitization). Follow-up assessments will be performed at 1 and 3 months after the intervention period.
Conclusions: The proposed study will contribute to previous literature by testing an innovative and non-invasive technique to treat chronic LBP. Despite potential methodological challenges, the analyses of clinical and neurophysiological markers will bring valuable information to the understanding of this burdensome condition.