Basivertebral Nerve Ablation Research Articles

ID: 340818 Basivertebral Nerve Ablation For the Treatment of Chronic Low Back Pain with Modic Changes

ID: 340818 Basivertebral Nerve Ablation For the Treatment of Chronic Low Back Pain with Modic Changes

Basivertebral Nerve Ablation for Treatment of Lower Back Pain.

Lower back pain (LBP) is a widely prevalent global health issue, affecting over half a billion people and remaining the leading cause of years lived with disability (YLDs). LBP significantly impacts healthcare systems, with substantial costs related to surgical procedures and lost workdays. Vertebrogenic back pain (VBP), characterized by specific clinical symptoms and associated with Modic changes (MC) in vertebral endplates, best seen on MRI, is a significant subset of LBP. This paper explores the pathophysiology, diagnosis, and current reports and studies focusing on VBP and the role of basivertebral nerve (BVN) ablation as a therapeutic intervention. Multiple studies, including randomized controlled trials (RCTs) and meta-analyses, demonstrate the efficacy of BVN ablation in reducing pain and improving function in patients with chronic LBP associated with MC.

A cost-effectiveness analysis of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

BACKGROUND CONTEXTRandomized trials have demonstrated the superiority of intraosseous basivertebral nerve ablation (BVNA) compared with sham and standard care in terms of improvements in pain, disability, and health-related quality of life in patients with vertebrogenic chronic low back pain (cLBP). PURPOSETo assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone. STUDY DESIGN/SETTINGA model-based economic analysis. PATIENT SAMPLEBase case analysis used INTRACEPT, a randomized trial comparing BVNA with standard care in 140 patients with vertebrogenic cLBP, recruited from 23 sites across the United States, with a follow-up, up to 5 years. Scenario analyses compared data from the Surgical Multicenter Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain (SMART) randomized trial against a sham control, and a single-arm study. OUTCOME MEASURESCosts and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER). METHODSA cost-effectiveness model was built in Microsoft Excel to evaluate the costs and health outcomes of patients undergoing BVNA using the Intracept Procedure (Relievant Medsystems) to treat vertebrogenic cLBP from a US payor perspective. Alternative scenario sensitivity analyses and probabilistic sensitivity analyses were conducted to assess the robustness of the model results. QALYs were discounted at 3.0% per year. RESULTSBase case analysis showed that BVNA relative to standard care alone was a cost-effective strategy for the management of patients with vertebrogenic cLBP, with an ICER of US$11,376 per QALY at a 5-year time horizon from introduction of the procedure. Modeling demonstrated a >99% probability that this was cost effective in the US, based on a willingness-to-pay threshold of US$100,000 to US$150,000. Various sensitivity and scenario analyses produced ICERs that all remained below this threshold. CONCLUSIONSBVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone.

Computed Tomographic Characterization for Basivertebral Nerve Ablation Utilizing a Radiofrequency Multitined Expandable Electrode

Computed Tomographic Characterization for Basivertebral Nerve Ablation Utilizing a Radiofrequency Multitined Expandable Electrode

Basivertebral nerve ablation technique

Chronic low back pain represents a leading cause of global disability, but can often be complex in etiology, with multiple pain generators contributing to patient discomfort. Anterior column low back pain involves the vertebral bodies and discs, with the vertebral body endplates now known to be a significant pain generator. Vertebrogenic low back pain secondary to irritation of the basivertebral nerve presents as axial discomfort, worse with forward flexion, and with concomitant Type I or II Modic changes on MRI. Minimally invasive basivertebral nerve radiofrequency ablation has emerged as an effective intervention for managing anterior column back pain. In this article, the authors present a comprehensive approach to identifying and treating vertebrogenic low back pain through image guided basivertebral nerve ablation. We outline the patient presentation and diagnostic workup, followed by a detailed procedural guide including equipment requirements, technique execution, and potential technical challenges and complications.

86. Intraosseous basivertebral nerve ablation for the treatment of vertebrogenic pain: pooled 4-year results from two long-term follow-up studies

86. Intraosseous basivertebral nerve ablation for the treatment of vertebrogenic pain: pooled 4-year results from two long-term follow-up studies

Potential Cost Savings with 60-day Peripheral Nerve Stimulation Treatment in Chronic Axial Low Back Pain.

Chronic axial low back pain (CLBP) that is not responsive to medication management or physical therapy often requires significant clinical intervention. Several interventional pain management options exist, including a 60-day peripheral nerve stimulation (PNS) treatment. This economic evaluation investigated the potential for projected cost savings associated with prioritizing 60-day PNS treatment relative to a 'standard of care' (SOC) approach (where patients do not have access to 60-day PNS). A decision tree (supervised machine learning) model tracked treatment progression across two hypothetical cohorts of US patients with CLBP in whom non-interventional options were ineffective (Cohort A: treatment starting with 60-day PNS followed by any additional interventional and surgical treatments versus Cohort B: standard of care interventional and surgical treatments without access to 60-day PNS). Treatment efficacy estimates were based on published success rates. Conditional on treatment failure, up to two additional interventions were considered within the 12-month time frame in both cohorts. SOC treatment options included epidural injection, radiofrequency ablation (RFA), basivertebral nerve ablation (BVNA), PNS permanent implant (PNS-PI), spinal cord stimulator (SCS) trial/implant, and spinal fusion surgery. Treatment choice probabilities in both cohort algorithms were based on clinician interviews. Costs were based on national Medicare reimbursement levels in the ambulatory surgery center (ASC) setting. Savings reflected the difference in projected costs between cohorts. A Monte Carlo simulation and sensitivity analyses were conducted to generate confidence intervals and identify important inputs. The treatment algorithm which prioritized initial 60-day PNS treatment was projected to save $8056 (95% CI $6112-$9981) per patient during the first year of interventional treatment relative to the SOC approach. Use of the 60-day PNS treatment as an initial interventional treatment in patients with CLBP may result in significant savings for Medicare. Projected savings may be even larger for commercial payers covering non-Medicare patients.

Progress of intraosseous basivertebral nerve ablation for symptomatic Modic alterations

Chronic lumbar and back pain caused by degenerative vertebral endplates presents a challenging issue for patients and clinicians. As a new minimally invasive spinal treatment method, radiofrequency ablation of vertebral basal nerve in bone can denature the corresponding vertebral basal nerve through radiofrequency ablation of degenerative vertebral endplate. It blocks the nociceptive signal transmission of the vertebral base nerve, thereby alleviating the symptoms of low back pain caused by the degenerative vertebral endplate. At present, many foreign articles have reported the operation principle, operation method, clinical efficacy and related complications of radiofrequency ablation of the vertebral basal nerve. The main purpose of this paper is to conduct a comprehensive analysis of the current relevant research, and provide a reference for the follow-up clinical research.

Basivertebral Nerve Radiofrequency Ablation (Intracept): Procedural Technique.

Intraosseous basivertebral nerve ablation is indicated for the treatment of chronic vertebrogenic low back pain with failure of at least 6 months of conservative treatment. This article details patient positioning and setup, step-by-step instructions for the procedure, and postoperative management. Pearls and pitfalls are also discussed. In addition, an instructional procedure video accompanies this paper and can be found online (at https://vimeo.com/791578426/de0e90cfbe).

Abstract No. 265 Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain with Modic Changes in a Community Practice Setting: 12 Months Follow-Up

Abstract No. 265 Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain with Modic Changes in a Community Practice Setting: 12 Months Follow-Up

Assessment and management of patients developing low energy vertebral compression fractures following basivertebral nerve ablation.

Assessment and management of patients developing low energy vertebral compression fractures following basivertebral nerve ablation.

Low back pain-related healthcare utilization following intraosseous basivertebral nerve radiofrequency ablation: a pooled analysis from three prospective clinical trials.

The effectiveness and safety of intraosseous basivertebral nerve ablation (BVNA) for treating vertebrogenic pain is established, but low back pain-related healthcare utilization (LBPr-HU) following BVNA continues to be defined. LBPr-HU data were pooled from 3 prospective studies. LBPr-HU categories of interest included non-invasive conservative care, opioid utilization, lumbosacral spinal injection (LSI), lumbosacral radiofrequency ablation (LRFA), and lumbosacral spinal surgery. Pre- and post-BVNA LBPr-HU were compared at both 1- and 5-years using McNemar's test for proportions and paired t-tests for means. Two hundred forty-seven patients received BVNA and had 1-year follow-up; 205 had long-term follow-up (mean of 5.3 ± 1.33 years). Twenty-seven percent fewer participants initiated conservative care in the year post-BVNA compared to the year preceding BVNA (P < .001; 95% CI 19.8-34.5). Of 77/247 participants taking opioids at baseline, 40.3% and 61.7% fewer were taking them at one-year and 5.3 ± 1.33 years post-BVNA, respectively (P < .001). Of participants receiving LSIs in the year preceding BVNA, 81.2% fewer received LSI(s) in the year post-BVNA (P < .001; 95% CI 70.7-90.7); a 76.4% reduction in LSIs was maintained through a mean of 5.3 ± 1.33 years post-BVNA. LRFA rates were 1.6% at 1-year post-BVNA and 8.3% at 5.3 ± 1.33 years post-BVNA. Lumbar fusion surgery was 0.8% at 1-year post-BVNA and 6.5% at 5.3 ± 1.33 years post-BVNA. In this aggregate analysis of patients with vertebrogenic pain, utilization of conservative care, opioids, LSIs, and LRFA were substantially reduced through 5 years post-BVNA compared to baseline. Lumbar fusion rates were less than half the published value at 5 years in similar populations.

P58. Basivertebral nerve ablation for the treatment of chronic low back pain with modic changes in a community practice setting: 12-months follow-up

P58. Basivertebral nerve ablation for the treatment of chronic low back pain with modic changes in a community practice setting: 12-months follow-up

Pain Management Interventions for the Treatment of Chronic Low Back Pain: A Systematic Review and Meta-Analysis.

Determine the relative effectiveness and safety profiles of percutaneous and minimally invasive interventions for chronic low back pain. A systematic search was performed for randomized controlled trials published in the past 20 years reporting on radiofrequency ablation of the basivertebral, disk annulus and facet nerve structures, steroid injection of the disk, facet joint, and medial branch, biological therapies, and multifidus muscle stimulation. Outcomes evaluated included Visual Analog Scale (VAS) pain scores, Oswestry Disability Index (ODI) scores, quality of life (SF-36 and EQ-5D) scores, and serious adverse event (SAE) rates. Basivertebral nerve (BVN) ablation was chosen as the subject of comparison to all other therapies using a random-effects meta-analysis. Twenty-seven studies were included. BVN ablation was found to provide statistically significant improvements in VAS and ODI scores for 6-, 12- and 24-month follow-up ( P ≤0.05). Biological therapy and multifidus muscle stimulation were the only 2 treatments with both VAS and ODI outcomes not significantly different from BVN ablation at 6-, 12-, and 24-month follow-up. All outcomes found to be statistically significant represented inferior results to those of BVN ablation. Insufficient data precluded meaningful comparisons of SF-36 and EQ-5D scores. The SAE rates for all therapies and all reported time points were not significantly different from BVN ablation except for biological therapy and multifidus muscle stimulation at the 6-month follow-up. BVN ablation, biological therapy, and multifidus stimulation all provide significant, durable improvements in both pain and disability compared with other interventions, which provided only short-term pain relief. Studies on BVN ablation reported no SAEs, a significantly better result than for studies of biological therapy and multifidus stimulation.

Intraosseous basivertebral nerve ablation: Pooled long-term outcomes from two prospective clinical trials

BackgroundVertebrogenic pain is an established source of anterior column chronic low back pain (CLBP) resulting from damaged vertebral endplates with pain signals transmitted by the basivertebral nerve (BVN). Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI) are objective biomarkers for vertebrogenic pain. Radiofrequency ablation of the BVN (BVNA) has demonstrated both efficacy and effectiveness for the treatment of vertebrogenic pain in two randomized trials. Here, we report 3-year aggregate results from two prospective studies of BVNA-treated patients. MethodsPooled results at 3 years post-BVNA are reported for two studies with similar inclusion/exclusion criteria and outcomes measurements: 1) a prospective, open label, single-arm follow-up of the treatment arm of a randomized controlled trial (RCT) comparing BVNA to standard care (INTRACEPT Trial), and 2) a prospective, open label, single cohort long-term follow-up study of BVNA-treated patients. Paired datasets (baseline and 3-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided t-test with a 0.05 level of significance. ResultsThere were 95/113 (84%) BVNA patients who completed a 3-year visit across 22 study sites. At baseline, 71% of patients reported back pain for ≥5 years, 28% were taking opioids, 34% had spinal injections in the prior 12 months, and 14% had prior low back surgery. Pain and functional improvements were significant at 3 years with a mean reduction in NPS of 4.3 points from 6.7 ​at baseline (95% CI 3.8, 4.8; p<0.0001) and a mean reduction in ODI of 31.2 points from 46.1 ​at baseline (95% CI 28.4, 34.0; p<0.0001). Responder rates, using minimal clinically important differences of ≥15-points for ODI and ≥50% reduction in NPS from baseline to three years, were 85.3% and 72.6%, respectively (combined response 69.5%), with 26.3% of patients reporting 100% pain relief at 3 years. There was a 74% reduction in the use of opioids and 84% reduction in the use of therapeutic spinal interventions from baseline to 3 years. There were no serious device or device-procedure related adverse events reported through three years. ConclusionIntraosseous BVNA demonstrates statistically significant, clinically meaningful, and durable improvements in pain and function through 3 years in patients with primary vertebrogenic low back pain. BVNA-treated patients significantly reduced opioid use and interventions for low back pain.

Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain In A Community Practice Setting: A Prospective Study (P9-6.003)

<h3>Objective:</h3> To demonstrate the feasibility of basivertebral nerve ablation (BVNA) in a community practice setting to alleviate pain in patients suffering from chronic low back pain (CLBP). <h3>Background:</h3> Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic CLBP. This data represents the clinical outcomes for 19 consecutively treated patients in a community setting. To our knowledge, this is the first independent clinical study on this novel procedure. <h3>Design/Methods:</h3> Evaluations were performed at baseline, 1 month, 3 months and 6 months and data recorded in Medrio electronic data capture software. Clinical improvements were recorded using the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Quebec Disability Scale and RAND-36 scale. Statistical analysis was performed using Graphpad Prism software. A non-parametric Friedman test followed by Dunn9s post-hoc analysis was used with a significance level set at p=0.05. All the patients (n=19) completed the baseline, 1 month and 3 months follow-up at the time this abstract was prepared, and 14 had completed the 6-months follow-up. <h3>Results:</h3> The ODI, VAS and Quebec Disability Scales showed significant improvement at 1 month (p=0.019, 0.015, 0.019), 3 months (p=0.012, 0.030, 0.000) and 6 months (p=0.030, 0.001, 0.000). The average ODI was reduced by 26 points in 6 months, VAS by 53.2 % and the Quebec Disability Scale by 34.9 points. The pain, physical functioning, energy/fatigue and social functioning outcomes of the RAND-36 testing also showed significant improvement over the 6 months follow-up. <h3>Conclusions:</h3> Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP which can be successfully implemented in a community practice setting. <b>Disclosure:</b> Dr. Schnapp has received intellectual property interests from a discovery or technology relating to health care. Mr. Martiatu has nothing to disclose. Dr. Delcroix has nothing to disclose.

The Effectiveness of Intraosseous Basivertebral Nerve Ablation in the Treatment of Nonradiating Vertebrogenic Pain: A Systematic Review.

Intraosseous basivertebral nerve ablation has shown sustained efficacy in treating chronic axial low back pain (LBP) in patients with type 1 or 2 Modic changes. This systematic review aims to determine the efficacy of intraosseous basivertebral nerve radiofrequency ablation in treating nonradiating axial chronic LBP compared to standard therapy, sham, or without contrast. The population of interest is individuals greater than or equal to 18 years old with chronic nonradiating vertebrogenic pain. The key outcome was the percentage of patients with greater than or equal to 50% pain reduction, greater than or equal to 10-point improvement in function and disability measured by the Oswestry Disability Index (ODI), greater than or equal to two-point pain reduction in the visual analog scale (VAS) or numerical pain rating scale, and a decrease in opioid utilization by 10 morphine milligram equivalents. Three databases, PubMed, MEDLINE, and Google Scholar, were used to retrieve the studies for the review. Two independent reviewers assessed the studies for inclusion using the validated tools for quality appraisal.There were 286 articles in total; however, only 11 publications with extensive data on 413 participants matched the inclusion criteria and were used for this review.At three months, a majority of theparticipants reported greater than or equal to 10-point improvement in the ODI, a measure of functional and disability improvement on a 10-point scale, and greater than or equal to two-point improvement in the VAS. A good number of patients in the basivertebral nerve ablation (BVNA) arm reported complete pain resolution demonstrating therapy success and the superiority of BVNA over sham and standard treatment. Basivertebral nerve radiofrequency ablation, among other criteria, is a safe and minimally invasive therapy that significantly lowers pain and impairment in individuals with vertebrogenic pain with distinct Modic type 1 and 2 changes at lumbar vertebra three-sacral vertebra one (L3-S1) vertebral levels. Proper patient selection and exact procedural methods are essential to the success of basivertebral nerve neurotomy. The findings of the existing investigations require confirmation by nonindustry-funded, large-scale, high-quality trials using generalizable study participants.

Abstract No. 119 Intraosseous Basivertebral Nerve Ablation 3-Year Effectiveness and Safety Results A Pooled Cohort Study of Two Prospective Clinical Trials

Abstract No. 119 Intraosseous Basivertebral Nerve Ablation 3-Year Effectiveness and Safety Results A Pooled Cohort Study of Two Prospective Clinical Trials

Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data

Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data

Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data

Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data