FDA Approves Nerve Ablation Device for Low Back Pain
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.
Low back pain has a lifetime prevalence of up to 84%, with an estimated 23% of cases characterized as chronic.1 It is the top cause of disability worldwide and the second leading cause of disability among US adults.2,3 Opioid prescribing for low back pain has increased despite associated risks and a lack of evidence supporting long-term efficacy.4 There is a clear need for effective, low-risk treatment alternatives, and a new device may provide relief for some patients.
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.
Summary and Clinical Applicability
New nerve ablation device receives FDA approval for treatment of low back pain but may have limited applicability.
*This Medgadget video demonstrates utilization of the device:
Steven P. Cohen, MD, discloses being a former advisory board member for Halyard, a manufacturer of radiofrequency ablation products.
- Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012; 379(9814):482-491.
- Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis doi:10.1136/annrheumdis-2013-204428
- Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults--United States, 1999. JAMA. 2001; 28;285(12):1571-2.
- Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. BMJ. 2015; 350:g638
- PR Newswire. Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT® for the Relief of Chronic Low Back Pain. Retrieved 8/25/16 from http://www.prnewswire.com/news-releases/relievant-medsystems-inc-receives-fda-510k-clearance-for-intracept-for-the-relief-of-chronic-low-back-pain-300301913.html