Evaluating Two Types of Lumbar Radiofrequency Ablation Compared to a Simulated Procedure for Chronic Low Back Pain

What this Trial Is About

This research aims to assess the effectiveness of lumbar radiofrequency ablation LRFA for people with chronic low back pain CLBP. The study compares two types of LRFA proceduresusing conventional electrodes placed parallel to the medial branch nerves LRFA-C and multi-tined electrodes placed perpendicular to those nerves LRFA-Magainst a simulated procedure that mimics the treatment without applying heat. This trial addresses the need for clear evidence on whether LRFA provides meaningful benefits for improving back-related function and pain. Participants will be randomly assigned to one of three groups LRFA-C, LRFA-M, or a simulated LRFA control. Both LRFA procedures involve targeting medial branch nerves with electrodes, administering local anesthetic, generating radiofrequency lesions at specific temperatures and durations, and applying corticosteroid injections at each site. The simulated procedure follows the same steps but does not generate lesions instead, it uses recorded sounds to mimic the treatment duration. The study measures differences in procedure time, radiation exposure, and pain during the intervention between the two LRFA methods. During the study, participants will be followed and evaluated at multiple points, including 1, 3, 6, and 12 months after randomization. Researchers will assess back-related functional limitations and pain intensity, as well as pain interference with daily activities. They will also monitor procedure duration, radiation dose, and any need for further procedural treatment for CLBP. These assessments involve questionnaires and clinical evaluations to understand the impact of each treatment method over time.

A Superiority Trial of Radiofrequency Ablation for Low Back Pain