Radiofrequency Ablation of the Basivertebral Nerve Shows Efficacy in Case Series

Peer Reviewed

Patients treated with radiofrequency ablation (RFA) of the basivertebral nerve (BVN) reported significant improvements in Oswestry Disability Index (ODI), visual analog scale (VAS), and quality of life measures at 3 months post-treatment in a prospective open-label case series published in the July issue of the European Spine Journal.

“The findings of this study are in keeping with earlier studies of basivertebral nerve ablation,” said lead author Eeric Truumees, MD, Professor of Orthopaedic Surgery at The University of Texas Dell Medical School, and CEO of the Seton Brain and Spine Institute, both in Austin, TX. “In our study, the percentage of people reporting >10 or >20 point improvements in ODI with radiofrequency ablation was 93% and 75%, respectively. These improvements appear durable, at least up to 2 years, though we have a longer-term follow-up study of our original study patients currently underway.”

Study Design and Inclusion Criteria

The study included 28 consecutive patients (median age, 45 years) treated at two outpatient community spine clinics between June 2019 and January 2019. All patients had chronic low back pain, were skeletally mature, had Type 1 or Type 2 Modic changes demonstrated on MRI at >1 vertebral bodies from L3 through S1, had an ODI score ≥30 and VAS >4, and failed to respond to ≥6 months of conservative care. The median VAS was 6.36, and two thirds of patients were symptomatic for ≥5 years. None of the patients had spinal stenosis, disc protrusion >5 mm, spondylolisthesis >2 mm, or radiculopathy.

Intraosseous RFA of the BVN was conducted using a unilateral transpedicular delivery system (Intracept System, Relievant Medsystems). “Targeted location for electrode placement was approximately 30% to 50% across vertebral body width from the posterior wall, and in the same horizontal plane as the BVN on sagittal imaging. After confirmation of placement, thermal ablation was delivered for 15 minutes at 85°C to create an approximately 1 cm spherical lesion within each vertebral body,” the researchers noted.

Significant Improvements in ODI and VAS Found

Significant improvements in ODI score (primary outcome) as well as VAS scores were found at 3 months post-treatment (Figures 1 and 2; P< 0.0001 for both measures). Responder rates on the ODI and VAS were high (Figure 3).

Significant improvements in overall SF-36 scores (mean change, +26.06), as well as physical (+15.78) and mental (+4.23) subscales were found (P<0.0001 for all measures). Significant improvements in the EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L) also were found, with a mean increase of 0.198 (P<0.0001).

Four of 8 patients taking opioids at baseline stopped using these medications by 3 months.

“This study reaffirms, using a ‘real-world’ environment, the results of a prior efficacy trial on the role of radiofrequency ablation of the BVN for treatment of vertebrogenic CLBP [chronic low back pain],” the researchers noted.

chart shows ODI improvement in 28 patients with CLBPFigure 1. Improvements in ODI from baseline to 3 months in 28 patients treated with RFA of the BVN for treatment of vertebrogenic chronic low back pain. Source: Truumees E, et al. Eur Spine J. 2019;28(7):1594-1602.

chart shows VAS improvement in 28 patients with CLBPFigure 2. Reduction in VAS from baseline to 3 months post-treatment in 28 patients treated with RFA of the BVN for treatment of vertebrogenic chronic low back pain. Source: Truumees E, et al. Eur Spine J. 2019;28(7):1594-1602.

chart shows ODI and VAS responder rates in 28 patientsFigure 3. Responder rates on the ODI and VAS in 28 patients treated with RFA of the BVN for treatment of vertebrogenic chronic low back pain. Source: Truumees E, et al. Eur Spine J. 2019;28(7):1594-1602.

Favorable Risk/Benefit Profile

Five adverse events were reported in the study, none of which were serious. Two patients developed leg pain that was thought to be related to pedicle tract issues, and both of these events resolved within approximately 3 months with no need for further intervention other than oral medication.

Findings Confirm Randomized Controlled Trial Data

“This article was documentation of well-structured research, making the results better to appreciate,” commented SpineUniverse editorial board member Reginald Knight, MD, MHA, who is an orthopaedic spine surgeon and Director of the Bassett Spine Care Institute in Cooperstown, NY. “The summary suggests that the results reported in the initial RCT of the BVN are reproducible.”1

“The risk/benefit profile shown here is more inclined towards benefit,” Dr. Knight said. “The expanded inclusion criteria were not unreasonable, and complications were minor.”

“Ongoing open-label reports of well-structured studies are necessary to further confirm utility of this procedure in a difficult patient population,” Dr. Knight noted. “While this study provides additional information in support of this procedure, there should be caution used whenever the initial inclusion criteria are expanded. In addition, narcotic use is a multifactorial issue and more attention should be directed towards the psychosocial aspects of chronic low back pain.”

The Effect of Patient Selection Criteria on Outcomes

“BVN ablation remains a relatively new procedure and, I’m sure, indications will evolve over time,” Dr. Truumees said. “Given the controversies surrounding the cause of low back pain, our study had relatively permissive entry criteria based on chronicity of symptoms and failed, first-line conservative therapies. The procedure was offered to patients with Modic changes.”

“Given these criteria, I was surprised to see such a high percentage of responders,” Dr. Truumees noted. “That said, as our numbers increase, I know we will better delineate optimal candidates. Still, unlike arthroplasty or fusion surgery, the complication rates and recovery time were very low.”

“Ultimately, this procedure is promising because it offers us a new, minimally invasive approach to patients with chronic back pain,” Dr. Truumees told SpineUniverse. “Both patients and physicians are often frustrated by their treatment options. While newer treatments have evolved, very few have expanded the pool of patients for whom care can be offered. I think basivertebral nerve ablation will expand the population of people benefitting from interventional and surgical spine care.

“I have been in practice for 20 years now, and have seen technologies come and go,” Dr. Truumees said. “I am constantly reminded of Scott’s parabola. Basivertebral nerve ablation is promising and does not seem to confer much risk to those trying it. However, close attention to long-term effects and benefits will be critical in determining the true position of this technology in our treatment pathways for chronic low back pain.”

Disclosures
The study was funded by Relievant Medsystems, Inc.
Seton Spine & Scoliosis Center received research funding from Relievant Medsystems, Inc.
Dr. Truumees does not have any relevant personal or financial disclosures.
Dr. Knight does not have any relevant personal or financial disclosures.

Updated on: 09/18/19
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