A Novel Image-Guided, Automatic, High-Intensity Neurostimulation Device for the Treatment of Nonspecific Low Back Pain

Abstract

Purpose. The current pilot study investigates the effectiveness of a novel device in the management of chronic low back pain (LBP). This device is able to automatically measure skin impedance in a selected body area and, immediately afterwards, to stimulate multiple points that are targeted according to differentiation in their electrical properties (peripheral nerve ends—milinated A δ fibers) with high-intensity electrical stimulation. Materials and Methods. Nineteen outpatients were included in the study, 15 females (79%) and 4 men (21%), mean age 52.1±10.8 years, all diagnosed with nonspecific chronic LBP. The protocol consisted of 6 treatment sessions, 2–4 days apart. Each session included a <1 minute automatic impedance screening, followed by a 20-minute treatment of lowest impedance points according to proprietary algorithms. Outcome Measures. The primary outcome measure consisted of changes in pain intensity as measured on a 100 mm pain visual analogue scale (VAS) obtained at enrollment, before and 2 hours after each treatment. Secondary outcome measures were the Oswestry Disability Index (ODI) and lumbar flexion range of motion (ROM) obtained at baseline and each week during treatment. Results. The mean±SD baseline VAS score for all participants was 61±14. There were no significant changes in VAS scores between enrollment and before the first treatment (55±16; P=.102). During treatment, VAS scores decreased significantly compared with baseline scores by 39±17 mm (P<.001). Notably, VAS scores of all the patients, except for one, decreased by more than 20 mm after the fourth treatment, thus showing marked improvement in 95% of enrolled patients. ODI decreased throughout the entire treatment period, with significant changes from baseline already at the first week (P=.001). Lumbar flexion ROM showed a mean increase of 2.1 cm during treatment, but was not statistically significant. Conclusion. The results of the current pilot study show that treatment with this novel device produced a clinically significant reduction in back pain in 95% of patients after four treatment sessions. The decrease both in pain and perceived disability, combined with the improvement in ROM, support further investigation of the use of this therapy in the treatment of LBP.