Evaluating Safety and Effectiveness of Neurolyser XR Device for Treating Low Back Pain Caused by Sacroiliitis

What this Trial Is About

This research aims to evaluate the use of the Neurolyser XR device, which delivers high-intensity focused ultrasound HIFU, for treating low back pain caused by sacroiliitis. Sacroiliitis involves inflammation and arthritis in the sacroiliac joint, which connects the sacrum to the iliac bone in the lower spine and bears the bodys weight. The study focuses on the safety and effects of using sound waves to target and damage nerves that carry pain signals from this joint. The treatment involves using the Neurolyser XR device to deliver focused ultrasound energy non-invasively to the lateral sacral branch nerves near the sacroiliac joint. This energy raises the temperature at the nerve site to intentionally damage the pain-transmitting fibers. Participants will receive this nerve ablation to study its impact on their pain. Participants will be monitored through various assessments including the number of treatment-related adverse events using standard criteria, pain levels measured by the Numerical Rating Scale, changes in pain medication use, and quality of life evaluated by the Oswestry Disability Index and Brief Pain Inventory. These evaluations will occur through a 6-month follow-up period. The study involves multiple visits for treatment and monitoring over this time to gather safety and effectiveness data.

Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis