Clinical Evidence Library
The published scientific evidence behind vertebrogenic low back pain and Basivertebral Nerve Ablation — organized in the order the science developed.
The studies presented in this Clinical Evidence Library have been selected to help patients and referring physicians better understand the published scientific evidence related to vertebrogenic pain and Basivertebral Nerve Ablation.
The summaries are intended for educational purposes and should be interpreted in the context of the original publications, which are linked throughout. Each study offers a short plain-language summary; expand Study details on any card to see the design, population, follow-up, key findings, and limitations.
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Two Kinds of Studies
The library includes both randomized trials and follow-up studies. Knowing the difference helps you weigh each one.
Randomized controlled trial
Random assignment and (where possible) blinding make it less likely that improvement is due to expectation. This is the strongest design for judging whether a treatment works.
Single-arm / follow-up study
Everyone receives the treatment and is tracked forward. These studies are valuable for durability and real-world use, but without a control group they carry more uncertainty.
How the Evidence Stacks Up
Researchers rank evidence by how well it controls for bias. Here is how the BVNA evidence is organized.
Studies higher on the pyramid generally carry more weight when guiding treatment decisions. Select any tier to jump to that part of the library.
The Evolution of the Evidence
From the first description of endplate changes on MRI to long-term outcomes and coverage — a timeline of the research.
- 1988
Modic changes defined
MRI patterns at the vertebral endplates are described — the imaging marker still used today.
- 1998–2003
The basivertebral nerve is mapped
Anatomy and tissue studies show the nerve inside the bone and that it can carry pain signals.
- 2018
First randomized sham-controlled trial
The SMART trial compares ablation against a placebo procedure.
- 2019
Second randomized trial
The INTRACEPT trial compares ablation against standard care; real-world prospective data begin.
- 2020
Long-term and community data
Five-year follow-up of the first trial; 12-month results from community practices.
- 2021
Durability confirmed
INTRACEPT 12- and 24-month results report sustained improvement.
- 2022
Evidence pooled; society guideline
A meta-analysis weighs the body of evidence; ASPN issues a Grade A best-practice guideline.
- 2023
Medicare coverage
CMS establishes limited coverage under defined clinical and MRI criteria.
- 2024
Five-year pooled analysis
Treated patients across three trials are analyzed together at roughly five years.
The People Behind the Numbers
Evidence is only as relevant as the patients it studied. Here is a summary of the population across the trials.
Across the studies, participants were adults with chronic low back pain of at least six months that had not improved with conservative care, and who had Type 1 or Type 2 Modic changes on MRI. Findings apply to this carefully selected population.
Foundational Science
The anatomy and imaging findings that explain why the vertebra itself can be a source of pain.
Innervation of the human vertebral body: a histologic study
Antonacci MD, Mody DR, Heggeness MH · Journal of Spinal Disorders · 1998
This early anatomy work helped establish that nerves travel deep inside the vertebral body, entering through a channel at the back of the bone. Identifying that the bone itself is innervated laid the groundwork for the idea that pain can originate from within the vertebra — not only from discs, joints, or muscles.
Study details
Substance P-containing nerves within the human vertebral body: an immunohistochemical study of the basivertebral nerve
Fras C, Kravetz P, Mody DR, Heggeness MH · The Spine Journal · 2003
This study found that the basivertebral nerve carries a chemical messenger (substance P) associated with transmitting pain. That detail matters: it suggests the nerve is capable of signaling pain from inside the bone, providing a biological rationale for why interrupting it might help certain patients.
Study details
Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging
Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR · Radiology · 1988
This landmark paper defined the MRI patterns now called "Modic changes" — signal changes at the vertebral endplates. These patterns (Type 1 and Type 2) became the imaging marker clinicians use to help identify vertebrogenic pain and to select candidates for basivertebral nerve ablation.
Study details
Randomized Controlled Trials
The highest-rigor studies, which randomly assign patients to compare basivertebral nerve ablation against a control.
Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study (SMART)
Fischgrund JS, Rhyne A, Franke J, et al. · European Spine Journal · 2018
This is the most rigorous kind of study: patients were randomly assigned and neither they nor the assessors knew who received the real procedure versus a placebo ("sham") procedure. Because of that design, it offers strong evidence that the improvements reported were related to the treatment itself rather than to expectation alone.
Study details
A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain (INTRACEPT)
Khalil JG, Smuck M, Koreckij T, et al. · The Spine Journal · 2019
The second randomized trial compared basivertebral nerve ablation against continued standard (non-surgical) care. An independent monitoring board stopped the comparison early because the ablation group was doing better, after which control patients were offered the procedure. It reinforced the randomized evidence in a real-world comparison.
Study details
Long-Term Follow-up
What happened to treated patients years later — a measure of durability.
Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study
Fischgrund JS, Rhyne A, Franke J, et al. · International Journal of Spine Surgery · 2019
A treatment only helps if the benefit lasts. This report followed the SMART trial's treated patients out to two years and found that the reported improvements in pain and function were generally maintained — an early signal that the effect can be durable.
Study details
Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results
Fischgrund JS, Rhyne A, Macadaeg K, et al. · European Spine Journal · 2020
This report extended follow-up of the original trial's treated patients to roughly five-plus years. The reported improvements were generally maintained over that span, supporting the idea that the benefit, when it occurs, can persist for years rather than fading quickly.
Study details
Intraosseous basivertebral nerve ablation: a 5-year pooled analysis from three prospective clinical trials
Khalil JG, Truumees E, Macadaeg K, et al. · Interventional Pain Medicine · 2024
By combining the treated patients from three trials, this analysis offers one of the largest long-term looks at the procedure. It reported lasting improvements in pain and function and, notably, reduced use of opioids and spinal injections — outcomes that matter to patients and the wider health system.
Study details
Prospective Clinical Studies
Studies that follow treated patients forward in time, including in everyday practice settings.
Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results
Smuck M, Khalil J, Barrette K, et al. · Regional Anesthesia & Pain Medicine · 2021
This report followed the INTRACEPT trial patients to one year. The reported improvements in pain and function were maintained at 12 months, extending the durability picture from the second randomized trial into the first year after treatment.
Study details
Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results
Koreckij T, Kreiner S, Khalil JG, Smuck M, Markman J, Garfin S · North American Spine Society Journal (NASSJ) · 2021
Extending the INTRACEPT patients to two years, this report found the improvements were generally durable. Together with the SMART long-term data, it strengthens the picture that benefit, when achieved, tends to persist.
Study details
A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain
Truumees E, Macadaeg K, Pena E, et al. · European Spine Journal · 2019
This study tested the procedure under more typical, everyday practice conditions rather than strict trial criteria. Early results echoed the randomized trials, helping show the findings may translate beyond the tightly controlled research setting.
Study details
A prospective, single-arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results
Macadaeg K, Truumees E, Boody B, et al. · North American Spine Society Journal (NASSJ) · 2020
Conducted in community practices rather than research centers, this study followed treated patients for a year. The reported one-year improvements were consistent with the trial data, supporting that results may hold up in routine clinical settings.
Study details
How Long Patients Were Followed
Several studies followed treated patients for years, which helps show whether benefit tends to last.
- Truumees — prospective (interim)3 months
- Macadaeg — community practice12 months
- Smuck — INTRACEPT12 months
- Koreckij — INTRACEPT24 months
- Fischgrund — SMART (2-year)24 months
- Khalil — 5-year pooled~5.6 years
- Fischgrund — SMART (5-year)~6.4 years
Longest reported follow-up per study. Longer follow-up helps show whether benefit, when it occurs, is durable.
Systematic Reviews & Meta-Analyses
Analyses that pool and weigh the body of evidence as a whole.
The effectiveness of intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebrogenic low back pain: an updated systematic review with single-arm meta-analysis
Conger A, Burnham T, Clark T, Teramoto M, McCormick ZL · Pain Medicine · 2022
Rather than one study, this analysis weighed the body of evidence together. Pooling results across studies gives a higher-level estimate of how often patients experience meaningful relief, and it reported consistent benefit across the available research.
Study details
Clinical Practice Guidelines
Expert societies reviewing the evidence and offering practice recommendations.
Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience
Sayed D, Naidu RK, Patel KV, et al. · Journal of Pain Research · 2022
When an independent expert society reviews the whole literature and issues recommendations, it reflects a degree of professional consensus. This guideline reviewed the evidence for vertebrogenic pain and basivertebral nerve ablation and provided practice recommendations for appropriately selected patients.
Study details
Coverage & Policy
How payers and policy bodies have evaluated the procedure.
Local Coverage Determination (LCD): Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain (L39420)
Centers for Medicare & Medicaid Services (CMS) · CMS Medicare Coverage Database · 2023
Coverage policies show how payers weigh the evidence when deciding what to reimburse. This Medicare determination established limited coverage for basivertebral nerve ablation for patients who meet specific clinical and MRI criteria after non-surgical care has not helped — a practical signal that the evidence met a coverage threshold.
Study details
Full Citations
Every study in this library, with a link to the original publication. Citations follow a consistent academic format.
- 1.Antonacci MD, Mody DR, Heggeness MH. Innervation of the human vertebral body: a histologic study. J Spinal Disord. 1998;11(6):526-531. View source
- 2.Fras C, Kravetz P, Mody DR, Heggeness MH. Substance P-containing nerves within the human vertebral body: an immunohistochemical study of the basivertebral nerve. Spine J. 2003;3(1):63-67. doi:10.1016/S1529-9430(02)00455-2 https://doi.org/10.1016/S1529-9430(02)00455-2
- 3.Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988;166(1 Pt 1):193-199. doi:10.1148/radiology.166.1.3336678 https://doi.org/10.1148/radiology.166.1.3336678
- 4.Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-1156. doi:10.1007/s00586-018-5496-1 https://doi.org/10.1007/s00586-018-5496-1
- 5.Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19(10):1620-1632. doi:10.1016/j.spinee.2019.05.598 https://doi.org/10.1016/j.spinee.2019.05.598
- 6.Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int J Spine Surg. 2019;13(2):110-119. doi:10.14444/6015 https://doi.org/10.14444/6015
- 7.Fischgrund JS, 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):1925-1934. doi:10.1007/s00586-020-06448-x https://doi.org/10.1007/s00586-020-06448-x
- 8.Khalil JG, Truumees E, Macadaeg K, et al. Intraosseous basivertebral nerve ablation: a 5-year pooled analysis from three prospective clinical trials. Interv Pain Med. 2024;3(4):100529. doi:10.1016/j.inpm.2024.100529 https://doi.org/10.1016/j.inpm.2024.100529
- 9.Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. 2021;46(8):683-693. doi:10.1136/rapm-2020-102259 https://doi.org/10.1136/rapm-2020-102259
- 10.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. N Am Spine Soc J. 2021;8:100089. doi:10.1016/j.xnsj.2021.100089 https://doi.org/10.1016/j.xnsj.2021.100089
- 11.Truumees E, Macadaeg K, Pena E, et al. A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019;28(7):1594-1602. doi:10.1007/s00586-019-05995-2 https://doi.org/10.1007/s00586-019-05995-2
- 12.Macadaeg K, Truumees E, Boody B, et al. A prospective, single-arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. N Am Spine Soc J. 2020;3:100030. doi:10.1016/j.xnsj.2020.100030 https://doi.org/10.1016/j.xnsj.2020.100030
- 13.Conger A, Burnham T, Clark T, Teramoto M, McCormick ZL. The effectiveness of intraosseous basivertebral nerve radiofrequency ablation for the treatment of vertebrogenic low back pain: an updated systematic review with single-arm meta-analysis. Pain Med. 2022;23(Suppl 2):S50-S62. doi:10.1093/pm/pnac070 https://doi.org/10.1093/pm/pnac070
- 14.Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain with basivertebral nerve ablation from the American Society of Pain and Neuroscience. J Pain Res. 2022;15:2801-2819. doi:10.2147/JPR.S378544 https://doi.org/10.2147/JPR.S378544
- 15.Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Thermal Destruction of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain (L39420). CMS Medicare Coverage Database; effective March 5, 2023. View source
How These Summaries Are Written
Each summary was written from the original publication and is intended to be educational, balanced, and free of marketing language. The page also shows selected numerical study information outside the expandable details; open the individual analyses and consult the original publications for the full context. This library does not reproduce copyrighted figures, tables, or charts from the journals; all graphics are original.
This library is provided for general education and does not constitute medical advice or a recommendation for any individual. Whether Basivertebral Nerve Ablation is appropriate depends on a personal evaluation — please discuss your situation with a qualified physician and refer to the original publications for complete details.
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