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

A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.

NCT Number	NCT07214844
Lead Sponsor	Montefiore Medical Center Collaborators: Pacira Pharmaceuticals, Inc
Conditions	Low Back Pain, Chronic
Enrollment	110 participants
Start Date	2026-04-16
Primary Completion	2028-05 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-17