BACKGROUND
Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease. Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases. Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the basivertebral nerve, has been purported to occur with endplate damage or degeneration.
Per the U.S. Food and Drug Administration (FDA) (2017), the Intracept Intraosseous Nerve Ablation System “is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care.” In 2025, Stryker announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) has FDA clearance. Medtronic plc is in a distribution agreement with Merit Medical Systems, Inc. to offer FDA-cleared (as of 2026) ViaVerte™, which is another minimally invasive and implant free basivertebral nerve ablation (BVNA) system.
In 2022, the American Society of Pain and Neuroscience (ASPN) released guidelines on interventional treatments for low back pain. Regarding basivertebral nerve ablation, the Society recommends basivertebral nerve ablation (Grade A with Level of Certainty 1a) for individuals with axial lower back pain of vertebrogenic nature.
In 2022, the International Society for the Advancement of Spine Surgery published updated guidelines on intraosseous basivertebral nerve ablation. The guideline was informed by a systematic review which included two randomized controlled trials (RCTs) and additional single-arm studies. The guideline authors concluded that intraosseous ablation of the basivertebral nerve from the L3 through S1 vertebrae may be considered medically indicated for individuals with chronic low back pain when all the following criteria are met:
- Chronic low back pain of at least 6 months duration.
- Failure to respond to at least 6 months of nonsurgical management.
- Magnetic resonance imaging-demonstrated MC1 or MC2 in at least 1 vertebral endplate at 1 or more levels from L3 to S1. (*Endplate changes, inflammation, edema, disruption, and/or fissuring.)
- Fibrovascular bone marrow changes (hypointense signal for Modic type 1).
- Fatty bone marrow changes (hyperintense signal for Modic type 2).
Any reliable evidence used for the above statements is discussed and analyzed below. PEER-REVIEWED LITERATUREFischgrund and colleagues conducted a randomized, double-blind, sham-controlled study (SMART trial) of basivertebral nerve ablation using the Intracept system in 225 participants from the U.S. and Europe. Individuals had chronic isolated lumbar pain that had not responded to at least 6 months of nonoperative management. Additional study inclusion criteria were a minimum Oswestry Disability Index of 30 points (on a 100-point scale), a minimum visual analog scale of 4, and Modic type 1 or 2 changes at the vertebral endplates of the levels targeted for treatment. Treatment was limited to a minimum of 2 and a maximum of 3 consecutive vertebral levels from L3 to S1. The active treatment group (n=147) received radiofrequency and the sham group (n=78) underwent the same protocol for the same overall duration as the treatment group; however, the radiofrequency treatment was simulated. Individuals were blinded to the group assignment for 1 year, at which time those in the sham arm were allowed to cross over, 57 (73%) of whom elected to do so, and receive the Intracept treatment. The primary endpoint of the original study was comparative change in Oswestry Disability Index from baseline to 3 months, and in the intent-to-treat analysis, there was no statistically significant difference in this outcome between groups at this time point. There was a difference between groups in the 3-month per-protocol analysis (mean Oswestry Disability Index improved 20.5 and 15.2 points in the treatment and sham arms, respectively; p=.019). However, at the 12 month per-protocol analysis, the difference in mean Oswestry Disability Index between groups was no longer statistically significant. Pain severity, measured by visual analog scale, was not significantly different between groups at 3 months (p=.083) but there was significantly greater improvement in the treatment group at 6 and 12 months.
The 24-month follow-up results were reported for the active treatment group from the SMART trial. Of the per-protocol population treated with ablation (treatment arm), 106 (83%) completed a 24-month follow-up visit. A durable Oswestry Disability Index mean improvement was observed (23.4 points). Data for Oswestry Disability Index outcomes were not available for the sham group because of the high crossover rate. Therefore, long-term comparative outcomes are not available.
Five-year results were reported for the 100 individuals (from the U.S.) from the treatment arm of the original SMART trial who were available for follow-up. Mean Oswestry Disability Index scores improved from 42.8 to 16.9 at 5 years, a reduction of 25.9 points. Mean reduction in visual analog scale score was 4.4 points (baseline 6.7, p<.001).
The INTRACEPT trial was an open-label randomized controlled trial (RCT) conducted at 20 U.S. sites. A total of 140 individuals with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized to undergo radiofrequency ablation of the basivertebral nerve or continue standard care. Standard care consisted of pain medications, physical therapy, exercise, chiropractic treatment, acupuncture, and spinal injections; the specific treatment(s) administered were determined by the treating investigator in conjunction with the individual. Treatment of up to 4 vertebrae in non-consecutive levels from L3 to S1 was allowed. The primary study endpoint was change in Oswestry Disability Index at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3-month follow-up (n=51 in the treatment group and n=53 in the standard care group), and reported statistically significant differences between groups on all individual-reported outcome measures, favoring the treatment group. The study was halted and the individuals were allowed to cross over to the treatment arm. Study limitations include short-term follow-up, lack of a sham group, and allowance of crossover at 3 months.
Twelve-month follow-up results were reported from the INTRACEPT trial; after a median of 175 days post-randomization, 92% of individuals initially randomized to the standard care arm elected to receive early treatment with basivertebral nerve ablation. Six-month results for the Oswestry Disability Index were significantly improved with basivertebral nerve ablation (n=66) compared to standard care (n=74) (least squares mean difference between groups, -24.5; 95% CI, -29.4 to -19.6; p=.0001). Improvements in the Oswestry Disability index and mean visual analog scale that were reported among individuals initially treated with basivertebral nerve ablation were maintained throughout the 12-month study period, with reported reductions of -25.7±18.5 points, and -3.8±2.6 cm, respectively (p<.001 for both comparisons to baseline). Improvements in pain, function, and quality of life were reported at 24 months; however, these results were also not comparative. The lack of comparative data beyond 6 months due to the high rate of crossover is a limitation of this trial.
McCormick et al (2025) published a single‑arm, prospective cohort study evaluating the effectiveness of basivertebral nerve radiofrequency ablation using the Intracept System in 60 adults with vertebrogenic low back pain lasting at least 6 months and associated with Type 1 or Type 2 Modic changes on lumbar MRI. Eligible participants had clinically suspected vertebrogenic low back pain unresponsive to at least 6 months of conservative care and underwent basivertebral nerve radiofrequency ablation at L2-S1 spinal levels exhibiting Modic changes. The primary outcome was mean improvement in Oswestry Disability Index score. Among 60 participants, mean Oswestry Disability Index score improvement was 13.9 ± 18.7 at 3 months and 14.0 ± 15.7 at 12 months. At 12 months, 52.8% achieved ≥30% Oswestry Disability Index score improvement (95% CI, 39.7 to 65.6) and 39.6% achieved ≥15‑point improvement (95% CI, 27.6 to 53.1). Four procedure‑related adverse events occurred, including one serious event (L5 radiculopathy with residual weakness).
SUMMARY
The above peer-reviewed and published literature is specific to the Intracept System. Currently, no direct reliable evidence could be located to evaluate any other FDA-approved/cleared devices in this space; therefore, no deductions regarding their clinical effectiveness and added clinical value(s) can be made .
Two RCTs have been conducted to assess the efficacy of basivertebral nerve ablation for treatment of vertebrogenic back pain. One RCT did not find a difference in the Oswestry Disability Index between individuals treated with basivertebral nerve ablation or sham control at 3 months using an intent-to-treat analysis. Although the per protocol analysis showed a significant difference; results for the per protocol population at 12 months were not significantly different. Additionally, 73% of individuals in this trial crossed over to the active treatment group at 12 months and therefore, long-term comparative data are not available. A second RCT found a significant difference in the Oswestry Disability Index and other pain scores between individuals treated with basivertebral nerve ablation and standard care at 3 months. Comparative data at 6 months postrandomization showed similar results. However, 92% of individuals initially assigned to standard care elected to cross over to receive early basivertebral nerve ablation, thus, long-term comparative data beyond 6 months are not available. Additional limitations to this RCT include lack of a sham control. In a small (n=60) prospective single-arm cohort, more than half of participants with vertebrogenic low back pain achieved at least a 30% improvement in Oswestry Disability Index score 12 months after treatment with basivertebral nerve radiofrequency ablation. Therefore, due to the aforementioned clinical & technical limitations, safety and effectiveness of this technology cannot be established at this time.
