Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial

Objective Although some studies have shown the clinical benefits of therapeutic exercise in chronic nonspecific low back pain, the effect sizes are generally small to moderate and recurrence rates are high. Transcranial direct current stimulation (tDCS) has been used to modulate pain-processing systems and motor outputs and has the potential to optimize the clinical benefits of therapeutic exercise. However, evidence for this combination is still lacking. The purpose of this protocol for a randomized clinical trial is to investigate whether the combination of tDCS and therapeutic exercise is more effective in relieving pain than therapeutic exercise alone. Methods This 2-arm, randomized controlled clinical trial will take place at the Federal University of Piauí, Brazil. Sixty patients will be randomized into 2 groups to receive tDCS (real/sham) + exercise therapies for 12 sessions over a period of 4 weeks. Pain intensity, sensory and affective aspects of pain, physical functioning, kinesiophobia, and global perceived effect will be recorded before treatment and at 4 weeks, 3 months, and 6 months after randomization. Data will be collected by an examiner unaware of (blind to) the treatment allocation. Impact This trial can potentially provide important information and assist in clinical decision-making on the combined use of tDCS to optimize the clinical benefits of therapeutic exercise in patients with chronic nonspecific low back pain.