Patient-Centered Chronic Spinal Pain Management Using Exercise and Neuromodulation: Study Protocol for a Randomized Controlled Trial

This randomized controlled trial (RCT) is structured as a double-blind, comparative, longitudinal design in accordance with the CONSORT guidelines. This RCT has been registered at ClinicalTrials.gov (NCT06969456). Forty-two participants diagnosed with PSPS-T2 will be randomized in a 1:1 ratio into two groups: tDCS + rehabilitation (E_tDCS) or sham tDCS + rehabilitation (E_SHAM). The intervention will use tDCS to deliver low-intensity direct current to modulate cortical excitability. The intervention will consist of 24 supervised sessions (2 per week, 60 min each) over 12 weeks. Neuromodulation and exercise protocols will be adapted to the intervention phases based on previous research. The sample size has been calculated using GPower^®, assuming an effect size of 0.81, α = 0.05, power = 0.95, and a 40% dropout rate. Data will be collected from October 2025 to January 2027. Impact Statement: This study integrates neurophysiological modulation via tDCS with targeted exercise therapy, presenting an innovative approach to enhance pain modulation, functional recovery, and cortical reorganization in patients with PSPT-2. This approach has the potential to inform future evidence-based strategies for neurorehabilitation and pain management.