In July 2016, the US Food and Drug Administration (FDA) approved a radiofrequency ablation device* that targets the basivertebral nerve for the treatment of chronic low back pain.5 The INTRACEPT® Intraosseous Nerve Ablation System from Relievant Medsystems, Inc. is intended for patients who have not responded to conservative treatment approaches for pain that has persisted for a minimum of 6 months.
The FDA approval was based on results of Relievant’s prospective, double-blind, randomized, sham-controlled clinical trial of 225 patients. The findings show that more than 75% of completers in the treatment arm demonstrated improvement of 10 points or more on the Oswestry Disability Index (ODI), and this group had a 48% reduction in scores from baseline to the 3-month follow-up assessment. These results were sustained at the 12-month and 24-month follow-up points.
Though these initial findings seem promising, the utility of the device may be limited to a small number of patients, according to Steven P. Cohen, MD, director of the division of pain medicine and professor of anesthesiology and critical care medicine, physical medicine and rehabilitation, at the Johns Hopkins University School of Medicine. He is aware of the device but said that he attends all major pain conferences and has not seen any relevant data at those events or in major journals.
He points to a couple of potential limitations of the INTRACEPT® approach. “The issue is that the vertebral bodies are not a very common source of low back pain. There is still a lot of controversy as to whether osteoporosis without stress fractures or other fractures can cause pain–clearly, they can affect posture,” he told Clinical Pain Advisor. He noted that vertebral augmentation procedures for fractures have produced mixed findings, and the scant number of studies on radiofrequency ablation of larger nerves, such as the sinuvertabral nerves are methodologically flawed.
In addition, performing “radiofrequency on small nerve branches is fraught with difficulty, including locating and capturing all of the nerves and trying to ensure that the pain is actually from the vertebral body,” he explained. “I would imagine that this may only be relevant for a relatively small subset of individuals, as people with pain from the vertebrae would almost certainly have pain from multiple other sources,” he said.