Study design: Prospective, single arm~Timeline: six month enrollment period and 12 months follow-up period.~Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic & Regenerative Medicine~Study population: Thirty adult patients diagnosed with facet related low back pain.~Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.~Safety is measured by the incidence and severity of treatment related adverse events.~Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain