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.