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

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Pain Management

Background:

• Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) involves altered brain pain processing and impaired natural pain management.
• Exercise therapy (motor control, spinal stabilization) aids pain and disability reduction but may be insufficient alone.
• Noninvasive brain stimulation (NIBS) is explored as an adjunctive treatment for spinal pain, leveraging its potential to address central nervous system changes.

Purpose of the Study:

• To assess the combined effect of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex and spinal motor control exercises in PSPS-T2 patients.
• To test the hypothesis that this combined intervention leads to a greater reduction in disability compared to exercise alone.
• To evaluate the impact on pain modulation, functional recovery, and cortical reorganization in PSPS-T2.

Main Methods:

• A randomized controlled trial (RCT) with a double-blind, comparative, longitudinal design following CONSORT guidelines.
• Forty-two PSPS-T2 participants randomized 1:1 to tDCS + rehabilitation or sham tDCS + rehabilitation.
• A 12-week intervention with 24 supervised sessions (2/week, 60 min each) combining neuromodulation and adapted exercise protocols.

Main Results:

• This section is to be filled after study completion as the study is prospective.
• The study is designed to collect data from October 2025 to January 2027.
• Sample size calculation based on GPower® indicates sufficient power (0.95) for detecting an effect size of 0.81, accounting for a 40% dropout rate.

Conclusions:

• This study integrates neurophysiological modulation via tDCS with targeted exercise therapy, presenting an innovative approach.
• The combined intervention has the potential to enhance pain modulation, functional recovery, and cortical reorganization in PSPS-T2 patients.
• Findings may inform future evidence-based strategies for neurorehabilitation and pain management in chronic spinal pain conditions.