In the October 2022 issue of the International Journal of Spine Surgery, the International Society for the Advancement of Spine Surgery (ISASS) published an updated Policy Statement and Literature Review of Intraosseous Basivertebral Nerve Ablation. This revised statement followed the September 2022 publication of Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Low Back Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience (ASPN).
While these publications underscore the substantial evidence supporting basivertebral nerve (BVN) ablation as a treatment for vertebrogenic pain, this pain source is still a relatively new concept for many physicians and patients. Before discussing BVN ablation as a treatment option, it is important to understand the science of vertebrogenic low back pain and its clinical presentation.
Shifting the Focus from Discs to Vertebral Endplates
Chronic low back pain (CLBP) is a widespread condition affecting an estimated 30 million people in the U.S. alone.[1] Not only does this result in a lower quality of life for patients but it also has a large economic impact, with direct costs estimated at $90 billion every year.[2]
For many years, the disc was presumed to be the source of most CLBP. Unfortunately, pain treatments centered on the disc have not always produced the desired results. More recent research has determined that the vertebral endplates – the interface between the disc and the vertebra – are the source of pain for many patients diagnosed with discogenic pain.
In 1991, Stephen Kuslich, MD, published findings from a study of awake patients who underwent surgery for herniated discs, spinal stenoses, or both.[3] When pressure was applied to the endplates, patients reported that it “frequently resulted in a deep, rather severe low back pain” that was more severe and sharper than their pain prior to surgery.
Subsequent research has strengthened the evidence that the vertebral endplates are an important source of CLBP. These efforts have demonstrated that endplates have more pain-sensing nerves (nociceptors) than discs,[4],[5],[6] with the pain signals carried by the BVN located within the vertebral body.[7],[8]
That’s not to say that discs play no role in CLBP. Discs and vertebral endplates are one functional unit – the “discovertebral complex” – and more recent study has explored the relationship between the two in causing pain.
Research published earlier this year found that accumulated damage to the discovertebral complex may cause chemical and mechanical sensitization of endplate nociceptors resulting in chronic vertebrogenic low back pain.[9] This damage allows proinflammatory disc tissue to leak into the bone marrow, leading to inflammation, with the BVN carrying pain signals from the inflamed endplates to the brain.
Understanding Vertebrogenic Pain
With the pathobiology of vertebrogenic pain better understood, what causes damage to the endplates in the first place?
Although some endplate damage is the result for trauma, endplates oftentimes become damaged due to disc degeneration and the wear and tear that occurs with everyday living. Patients will often describe vertebrogenic pain as being in the middle of their low back and made worse during physical activity, prolonged sitting, and by bending forward or bending and lifting.
For physicians, vertebrogenic pain can be indicated via MRI by looking for specific changes, including inflammation and edema in the vertebral body, as well as changes to the surrounding bone marrow. These changes are also referred to as Modic changes because, in 1988, Dr. Michael Modic first published research to identify and classify degenerative endplate and marrow changes surrounding a dehydrated intervertebral disc.[10]
BVN Ablation: The Treatment Option for Vertebrogenic Pain
With vertebrogenic pain indicated by common symptoms and a clear biomarker, what is the best treatment option for this particular type of CLBP?
First-line treatment for CLBP is often centered on conservative care, with treatments such as physical therapy, chiropractic care, non-opioid medications, and injections. If these more conservative treatment options don’t resolve the pain, patients may be prescribed opioid medications or recommended for an invasive surgery.
For patients diagnosed with vertebrogenic pain, treatment can be much more straightforward. As noted in the recent guidelines from both ISASS and ASPN, patients with vertebrogenic pain for more than six months that isn’t responding to conservative care are indicated for BVN ablation.
This minimally-invasive procedure utilizes targeted radiofrequency energy to heat the BVN to stop it from transmitting pain signals to the brain. The procedure is typically performed in an outpatient surgery center and takes approximately one hour. The procedure is also implant-free, preserving future treatment options for other spine conditions. Unlike other radiofrequency procedures for CLBP, BVN ablation has been demonstrated to produce long-term improvements in pain and function following a single treatment.[11]
Decades of Research Highlight Efficacy of BVN Ablation
Although the guidelines for BVN ablation from ISASS and ASPN are more recent, the study of the safety and effectiveness of BVN ablation for treating CLBP isn’t.
More than 30 years of research and results from multiple clinical trials – including two Level I RCTs – has led to some important conclusions, including:
- Significant improvements in function and pain seen at 3 months post-BVN ablation are sustained more than 5 years after a single treatment[12]
- After 5 years following BVN ablation, 65 percent of patients reported that they had resumed the level of activity they enjoyed prior to CLBP – with more than one-third of patients indicating they were totally pain-free[13]
- The safety of BVN ablation has been demonstrated, too, with a less than 0.3 percent rate of serious device procedure-related complications[14]
BVN Ablation: An Important Advancement in the Treatment of CLBP
The impact of CLBP is widespread – from the direct economic costs to the years of pain that patients endure while looking for a cure. Fortunately, research into the anatomy of the lower back has led to an understanding of vertebrogenic pain and what is available to treat it.
Although BVN ablation isn’t an option for every type of CLBP, this proven treatment is an important advancement to provide relief to the millions afflicted with low back pain and to help them get back to living.
Editor’s Note: Dr. Ray Baker joined Relievant in July 2017 and serves as Chief Medical Officer. Prior to joining Relievant, Dr. Baker was VP and Executive Medical Director of EvergreenHealth Medical Group, EvergreenHealth, Kirkland, Washington. During his 15 years at EvergreenHealth, Dr. Baker held positions on the board of the Evergreen Surgical Center, Chaired the EvergreenHealth Medical Group Leadership Council and was Medical Director of their Spine and Musculoskeletal Programs. Prior to being employed by EvergreenHealth, he was in private and academic practices. He served as Clinical Professor and Director of Interventional Pain Management at the University of Washington. He regularly lectures internationally and has published a number of peer-reviewed articles, book chapters and editorials. He continues to serve on numerous boards and committees and has advised CMS, the FDA and CDC on matters related to pain management. Dr. Baker previously Chaired the Multi-Society Pain Workgroup for CMS and is Past President of both the North American Spine Society and the Spine Intervention Society.
[1] Navigant Consulting Research Report, “CLBP Market Assessment,” Jan. 2018; on file Relievant Medsystems, Inc.
[2] Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J 2008;8:8-20.
[3] Kuslich, S.D. & Ulstrom, C.L. & Michael, C.J. (1991). The tissue origin of low back pain and sciatica: A report of pain response to tissue stimulation during operations on the lumbar spine using local anesthesia. The Orthopedic clinics of North America. 22. 181-7.
[4] Antonacci MD, Mody DR, Heggeness MH. Innervation of the human vertebral body: a histologic study. Journal of Spinal Disorders. 1998;11(6):526-31.
[5] Fields AJ, Liebenberg EC, Lotz JC. Innervation of pathologies in the lumbar vertebral endplate and intervertebral disc. The Spine Journal: Official Journal of the North American Spine Society 2014;14(3):513-521.
[6] Fras C, Kravetz P, Mody DR, Heggeness MH. Substance P-containing nerves within the human vertebral body: an immunohistochemical study of the basivertebral nerve. The Spine Journal: Official Journal of the North American Spine Society. 2003;3(1):63-7.
[7] Bailey JF, Liebenberg E, Degmetich S, Lotz JC. Innervation patterns of PGP 9.5-positive nerve fibers within the human lumbar vertebra. Journal of Anatomy 2011;218(3):263-70.
[8] Lotz JC, Fields AJ, Liebenberg EC. The Role of the Vertebral End Plate in Low Back Pain. Global Spine J 2013;03:153-64.
[9] Aaron Conger, DO, Matthew Smuck, MD, Eeric Truumees, MD, Jeffrey C Lotz, PhD, Michael J DePalma, MD, Zachary L McCormick, MD, Vertebrogenic Pain: A Paradigm Shift in Diagnosis and Treatment of Axial Low Back Pain, Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S63–S71, https://doi.org/10.1093/pm/pnac081.
[10] Modic MT, Steinberg PM, Ross JS et-al. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988;166 (1): 193-9.
11,13 Fischgrund J, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020;29(8):1925-34. doi.org/10.1007/s00586-020-06448-x.
12 Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results. NASSJ. Published online October 26, 2021. DOI: https://doi.org/10.1016/j.xnsj.2021.100089.
14Relievant data on file as of November 2022.
