Neurolyser XR for Chronic Low Back Pain

This trial tests a new device called Neurolyser XR, which uses focused sound waves to treat long-lasting lower back pain. The researchers aim to determine if this non-invasive treatment is safe and feasible for pain relief. The trial targets individuals over 55 who have experienced lower back pain for more than six months and find relief when lying down or sitting comfortably. Participants should also have experienced significant pain relief from previous specific back treatments. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for those seeking alternative pain relief solutions.

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving active treatment for rheumatologic diseases with steroids, disease-modifying drugs, biological agents, or immunosuppressants, you may not be eligible to participate.

Research has shown that focused ultrasound treatments, such as the Neurolyser XR device, are generally safe and effective for treating low back pain. Previous studies indicate that patients tolerate this treatment well. Although specific safety data for the Neurolyser XR itself is not available, similar treatments have not shown any serious side effects.

Researchers are excited about the Neurolyser XR device because it uses High Intensity Focused Ultrasound (HIFU) to provide a new way to manage axial chronic low back pain. Unlike traditional treatments like medications and physical therapy, which often focus on symptom relief, Neurolyser XR directly targets the medial nerve branch through thermal ablation. This innovative approach could offer more precise pain relief with potentially longer-lasting effects. By focusing on the nerve branch, this method aims to reduce pain without the need for invasive surgeries or long-term medication use, which could be a game-changer for many patients.

Research has shown that the Neurolyser XR, a device using focused sound waves, effectively treats long-term lower back pain. Clinical data indicate that it works similarly to radiofrequency ablation, a well-known treatment. In this trial, participants will receive treatment with the Neurolyser XR, which targets and heats a specific nerve to reduce pain. Studies have reported significant pain relief in patients who received this treatment. This non-invasive method appears promising for those suffering from chronic lower back pain.²⁵⁶⁷⁸