A randomized trial of a digitally delivered, home-based neuromodulation and mindfulness intervention for pain management in older adults with knee osteoarthritis

Knee osteoarthritis (OA) is a major cause of chronic pain and disability in older adults, yet scalable home-based interventions remain limited, partly due to the lack of clinically effective digital solutions. This study is the first fully powered randomized, double-blind, sham-controlled trial to test a digitally delivered, home-based protocol combining transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) for knee OA pain. A total of 208 participants were randomized to active tDCS + MBM, active tDCS + sham MBM, sham tDCS + active MBM, or double sham; they completed ten 20-min sessions over 2 weeks. Knee pain intensity was measured at baseline, post treatment, and monthly for 3 months. Although both active tDCS groups improved, the difference between the combined tDCS + MBM intervention and tDCS alone was not statistically significant. Benefits were not sustained at 3 months. These findings offer the first evidence that a remotely supervised, digitally delivered tDCS + MBM intervention can rapidly reduce knee OA pain, supporting future personalized and extended treatment studies. Clinical trial registration: ClinicalTrials.gov NCT04375072 (registered May 7, 2020).