RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

Facet Syndrome of Lumbar Spine Clinical Trial

Official title: Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Back Pain
• Facet Syndrome of Lumbar Spine
• Low Back Pain

• NCT number: NCT04519541
• Study type: Interventional
• Source: FUSMobile Inc.
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Completion date: January 31, 2023