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.
Subjects at least 18 years of age at Screening
Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
Low back pain is chronic (i.e., ≥ 3 months' duration)
Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
Infection
Tumor
Montefiore Medical Center
Lead sponsor
Pacira Pharmaceuticals, Inc
Collaborator