A feasibility report on a non-invasive dynamic neuromodulation device for chronic pain

Background Non-invasive dynamic neuromodulation (NIDN) automatically modulates stimulation frequency using real-time skin-impedance feedback. This study evaluated the feasibility, safety and exploratory clinical outcomes of NIDN in adults with chronic non-specific low back pain. Methods This single-arm feasibility study enrolled 45 adults, with eight 30-minute NIDN sessions scheduled over five weeks. Feasibility outcomes included recruitment, intervention adherence, retention and adverse events. Average pain intensity over the preceding week and disability were assessed using a 100-mm visual analogue scale and the Quebec Back Pain Disability Scale, respectively, at baseline and one and six weeks after treatment. Results Forty-five participants were recruited, 43 completed all sessions and 42 completed follow-up. No serious adverse events occurred. Median pain intensity decreased from 71 mm (IQR 58–77) at baseline to 29 mm (IQR 19–48) one week after treatment and 22.5 mm (IQR 12.5–38.8) at six weeks; 64% achieved a reduction of at least 50% at six weeks. Median disability improvement at six weeks was 31 points (IQR 19.3–49.0), with 86% exceeding the minimal detectable change of 15.8 points. Conclusions High adherence and retention support progression to a pilot randomised controlled trial incorporating a standard transcutaneous electrical nerve stimulation comparator and longer follow-up. The uncontrolled design and short follow-up preclude conclusions about efficacy or sustained benefit.