Clinical Trials Logo

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 6 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04129034
Study type Interventional
Source FUSMobile Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date September 24, 2019
Completion date March 26, 2023

See also
  Status Clinical Trial Phase
Completed NCT03770585 - Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome N/A
Active, not recruiting NCT05154448 - Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain N/A
Recruiting NCT04893720 - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Recruiting NCT06325631 - Comparative Evaluation of the Results of Facet Joint Injections N/A
Recruiting NCT03564418 - Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain. N/A
Completed NCT04519541 - RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain N/A
Recruiting NCT03871192 - Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome N/A