Study Comparing Iovera Lumbar Medial Branch Cryoneurolysis and Radiofrequency Ablation for Treating Chronic Facet-Mediated Low Back Pain

What this Trial Is About

Researchers are evaluating two different treatments for chronic low back pain caused by facet joint problems. This study compares the iovera system, which uses cold to treat certain nerves in the lower back, with the standard treatment called radiofrequency ablation, which uses heat. The study aims to find out which treatment better reduces back pain and improves quality of life over about a year. It is a randomized, double-blind study sponsored by Montefiore Medical Center. Participants will be randomly assigned to receive either iovera cryoneurolysis or radiofrequency ablation targeting the medial branch nerves of the lumbar spine. The iovera treatment involves using a needle and the iovera Smart Tip to apply cold cycles to the nerves, while the radiofrequency ablation uses a needle to deliver heat lesions at specific nerve locations. Both procedures are done under fluoroscopic guidance with local anesthesia. The study includes an adaptive design with an interim analysis after about 56 participants have completed the primary outcome assessment. Participants will be monitored before and after the treatment for about 12 months, with regular assessments of pain intensity using a numeric rating scale, functional disability, patient global impression of change, and overall health. Researchers will also evaluate safety outcomes, medication use, quality of life, and participant satisfaction with pain management. The study lasts approximately 14 months for each participant, including follow-up visits to track the long-term effects of the treatments.

A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain