Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

Facet Syndrome of Lumbar Spine Clinical Trial

Official title: High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study

Status Active, not recruiting

Clinical Trial Summary

Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain

Clinical Trial Description

Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects.

Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months 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 pain numerical rating scale ;

Related Conditions & MeSH terms

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

• NCT number: NCT05154448
• Study type: Interventional
• Source: FUSMobile Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2022
• Completion date: April 1, 2024