[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.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Bone marrow stromal cells in Modic type 1 changes promote neurite outgrowth.

The pain in patients with Modic type 1 changes (MC1) is often due to vertebral body endplate pain, which is linked to abnormal neurite outgrowth in the vertebral body and adjacent endplate. The aim of this study was to understand the role of MC1 bone marrow stromal cells (BMSCs) in neurite outgrowth. BMSCs can produce neurotrophic factors, which have been shown to be pro-fibrotic in MC1, and expand in the perivascular space where sensory vertebral nerves are located. The study involved the exploration of the BMSC transcriptome in MC1, co-culture of MC1 BMSCs with the neuroblastoma cell line SH-SY5Y, analysis of supernatant cytokines, and analysis of gene expression changes in co-cultured SH-SY5Y. Transcriptomic analysis revealed upregulated brain-derived neurotrophic factor (BDNF) signaling-related pathways. Co-cultures of MC1 BMSCs with SH-SY5Y cells resulted in increased neurite sprouting compared to co-cultures with control BMSCs. The concentration of BDNF and other cytokines supporting neuron growth was increased in MC1 vs. control BMSC co-culture supernatants. Taken together, these findings show that MC1 BMSCs provide strong pro-neurotrophic cues to nearby neurons and could be a relevant disease-modifying treatment target.

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 the participants 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.

Basivertebral nerve ablation for the treatment of chronic low back pain in a community practice setting: 6 Months follow-up.

Background: Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the clinical outcomes for 16 consecutively treated patients in a community practice setting. Methods: Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, and 6 months. The Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 were recorded in Medrio electronic data capture software. All patients (n = 16) completed the baseline, 1 month, 3 months, and 6 months follow-up. Results: The ODI, VAS, and SF-36 Pain Component Summary showed statistically significant improvements above minimal clinically important differences at 1 month, 3 months, and 6 months (all p values <0.05). Change in ODI pain impact declined 13.1 points [95% CI: 0.01,27.2] at one month from baseline, 16.5 points [95% CI: 2.5,30.6] at three months from baseline, and 21.1 points [95% CI: 7.0,35.2] six-months from baseline. SF-36 Mental Component Summary also showed some improvements, but with significance only at 3 months (p = 0.0091). Conclusions: Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation.

The interrater reliability of Modic changes among a potential basivertebral nerve ablation population: Why AC1 may be preferred to kappa.

Interrater reliability of Modic changes is subject to variables which affect consistency in reporting. Given the importance of Modic change identification for basivertebral nerve ablation (BVNA) candidacy, interrater reliability for this specific cohort has not yet been reported. Twenty lumbar magnetic resonance images of potential basivertebral nerve candidates were independently reviewed by two neuroradiologists and two interventional spine physiatrists for the presence and characterization of Modic changes. The kappa value of their agreement on the presence of Modic changes was 0.52 (95% confidence interval [CI] 0.37-0.67), whereas agreement on the type of Modic change was 0.51 (95% CI 0.37-0.65). Using an alternative methodology for measuring interrater reliability (Gwet's AC1) yielded the identification of the presence of Modic changes at AC1 0.51 (95% CI 0.36-0.66), whereas agreement on the type of Modic change was AC1 0.75 (95% CI 0.66-0.83). While less common, AC1 may be preferred in the appropriate cohort to kappa as it mitigates some of the pitfalls to which kappa values may be victim. Ultimately, our results are in-line with previous reports of interrater reliability results for Modic changes in other cohorts and should serve to caution those who perform BVNA regarding interrater agreement of the imaging crux of the procedure.

Narrative Review of Pathophysiology and Endoscopic Management of Basivertebral and Sinuvertebral Neuropathy for Chronic Back Pain.

Chronic lower back pain is a leading cause of disability in musculoskeletal system. Degenerative disc disease is one of the main contributing factor of chronic back pain in the aging population in the world. It is postulated that sinuvertebral nerve and basivertebral nerve main mediator of the nociceptive response in degenerative disc disease as a result of neurotization of sinuvertebral and basivertebral nerve. A review in literature is done on the pathoanatomy, pathophysiology and pain generation pathway in degenerative disc disease and chronic back pain and management strategy is discussed in this review to aid understanding of sinuvertebral and basivertebral neuropathy treatment strategies.

Anatomic description of the basivertebral nerve and meningeal branch of the spinal nerve in the dog.

PURPOSE: The existence of the basivertebral nerve and meningeal branch of the spinal nerve has not been proven in dogs to date. The objectives of this study are to 1) determine whether dogs have a meningeal branch of the spinal nerve (MBSN) and a basivertebral nerve (BVN) and to (2) describe anatomical characteristics of these two nerves. Authors also put forward a discussion on the possible clinical relevance of these findings. MATERIAL AND METHODS: Dissections were performed on six embalmed dogs at the Veterinary Faculty of Barcelona with the use of stereomicroscopy and microsurgery equipment. RESULTS: The MBSN (grossly) and BVN (grossly and histologically) were identified in the cervical, thoracic, and lumbar region in all dog specimens. In addition, other small fibers (suspected nerves) entering the vertebral body through small foramina close to the end plates were identified. Histological examination of the tissues confirmed the presence of nerve fibers (myelinated and unmyelinated) in suspected BVN samples. Results of the present study indicated that dogs have BVNs. Also, suspected nerve fibers were identified among the epidural fat, running from the intervertebral foramina, that likely represent the MBSN. CONCLUSION: These findings open up the discussion on extrapolation of treatment options employed in human medicine for "low back pain", such as BVN ablation, which is discussed in this article. Further anatomic and clinical studies of the innervation for the vertebral body, periosteum, vasculature, dorsal longitudinal ligament and anulus fibrosus are necessary to elucidate possible anatomical variants and breed differences as well as potential clinical (e.g., therapeutic) relevance.

ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation.

The index 2020 ISASS Guideline Statement "Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain" was generated in response to growing requests for background, supporting literature, evidence, as well as proper coding for intraosseous basivertebral nerve ablation. Since the guideline was published, the American Medical Association has added Current Procedural Terminology category I codes for basivertebral nerve ablation: 64628 and 64629. Additionally, the has recognized a need for greater specificity in differentiating various types of low back pain and has designatedthe International Classification of Diseases, 10th revision, Clinical Modification code M54.51, vertebrogenic low back pain, to ensure correct diagnosis. The timing of these additions provides an opportunity to refresh the ISASS Guideline to ensure proper diagnosis and procedural coding and to update the supporting literature and evidence.

Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience.

Chronic low back pain is a worldwide leading cause of pain and disability. Degenerative disc disease has been the presumptive etiology in the majority of cases of chronic low back pain (CLBP). More recent study and treatments have discovered that the vertebral endplates play a large role in CLBP in a term defined as vertebrogenic back pain. As the vertebral endplates are highly innervated via the basivertebral nerve (BVN), this has resulted in a reliable target in treating patients suffering from vertebrogenic low back pain (VLBP). The application of BVN ablation for patients suffering from VLBP is still in its early stages of adoption and integration into spine care pathways. BVN ablation is grounded in a solid foundation of both pre-clinical and clinical evidence. With the emergence of this therapeutic option, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidelines for the proper identification and selection of patients for BVN ablation in patients with VLBP. ASPN formed a multidisciplinary work group tasked to examine the available literature and form best practice guidelines on this subject. Based on the United States Preventative Task Force (USPSTF) criteria for grading evidence, gives BVN ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals.

Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature.

BACKGROUND: Chronic low back pain is a leading cause of disability worldwide and its pathophysiology remains poorly understood, a problem exacerbated by the heterogeneity of the patient population with chronic low back pain. Although the intervertebral discs are often implicated in chronic low back pain, studies have demonstrated strong innervation of the vertebral endplates by the basivertebral nerve, therefore making it a possible target for ablation in the treatment of vertebrogenic chronic low back pain. OBJECTIVES: This work reviews the current evidence for the efficacy and safety of basivertebral nerve ablation as a treatment modality for chronic low back pain, and discusses the possible study biases and gaps in the current knowledge to provide insight on future research. STUDY DESIGN: The authors registered with the Center for Open Sciences and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews  (PRISMA-ScR). SETTING: A private clinic. METHODS: This study was performed in accordance with the following 5-stage methodological framework for scoping reviews: (i) identifying the research question; (ii) identifying relevant studies; (iii) selecting studies; (iv) charting the data; and (v) collating, summarizing and reporting the results. Three databases (PubMed, Web of Science, Embase) were searched using the keywords "basivertebral", "nerve", and "ablation". RESULTS: From March 2002 to March 2022, a total of 47 articles were identified, of which 12 were included in this scoping review, based on the exclusion criteria described in Table 1. LIMITATIONS: The limitations found were: • A very specific chronic pain population is typically utilized for this intervention. The inclusion criteria leave many who experience chronic low back pain ineligible for the procedure. • Study demographics need to be more diversified to truly represent the chronic low back pain population.• There is a lack of true control groups due to high crossover rates in published studies.• Very few high-level or long-term studies have been published.• Funding for many of the studies published on the subject is industry-led (Table 6). With an already limited amount of published research, a need for out-of-industry funding is required to avoid any possibility of bias. CONCLUSIONS: Current research has shown that basivertebral nerve ablation might be a promising treatment for chronic low back pain in patients exhibiting Modic type 1 or 2 endplate changes, while additional research on the association between Modic changes and low back pain is still needed to gain widespread use and acceptance of this new treatment modality. The introduction of new devices and a larger number of independent studies would greatly enhance the confidence in the outcomes reported with this treatment modality in order to ultimately benefit patients, clinicians, and society.

Basivertebral Nerve Ablation.

Low back pain is one of the most prevalent musculoskeletal ailments in the United States. Intraosseous radiofrequency ablation of the basivertebral nerve is an effective and durable therapy for low back pain and can be offered to patients who have chronic low back pain of greater than 6 months of duration, failure to respond to noninvasive therapies for 6 months, with either Modic Type I or Type II changes at L3-S1. This article reviews the anatomy and physiology, patient selection, technique, and evidence regarding basivertebral nerve ablation.

Novel Technologies in Interventional Pain Management.

This article comprehensively covers 3 major novel technologies and techniques in the management of chronic lower back pain. The first 2 procedures, percutaneous interspinous spacer implantation, and minimally invasive lumbar decompression have shown significant impact in the management of lumbar spinal stenosis (LSS), especially in patients who are not great surgical candidates or are otherwise not amenable to open spinal surgery. The wealth of data for these procedures continues to increase, with up to 4 to 6-year follow-up data recently being made available. A novel solution for vertebrogenic back pain is also discussed as follow-up data emphasizes the safety and sustainability of the procedure. This article also establishes a framework for evaluating novel technologies in interventional pain management.

Utilidad de la termorizotomía percutánea del nervio basivertebral para el tratamiento del dolor lumbar crónico. Revisión de la literatura / Usefulness of percutaneous basivertebral nerve thermorizotomy for the treatment of chronic low back pain. Literature review

Introducción: El dolor lumbar vertebrogénico es un concepto nuevo que se agrega a las otras formas semiológicas y fisiopatológicas preexistentes de dolor en esta región. Se produce por una lesión en los platillos vertebrales cartilaginosos. A raíz de este nuevo concepto han surgido estrategias terapéuticas novedosas como la termorizotomía percutánea del nervio basivertebral. Objetivos: El objetivo principal de este estudio es evaluar los resultados clínicos de los pacientes con diagnóstico de dolor vertebrogénico que fueron tratados con termorizotomía percutánea del nervio basivertebral (NBV). Se analizará la respuesta del dolor, la funcionalidad y la calidad de vida. Métodos: Bajo los parámetros de la metodología PRISMA se realizó una búsqueda en las bases de datos Pubmed y Embase con los términos “Intraosseous basivertebral nerve ablation”, “Basivertebral nerve AND Intracept”, “INTRACEPT“, “Intraosseous basivertebral nerve ablation AND Intracept”, “vertebrogenic low back pain”. Posterior a la búsqueda, los artículos fueron inicialmente revisados de manera independiente por cada uno de los autores, se filtraron los artículos repetidos, obteniendo 8 estudios poblacionales. Considerando la poca cantidad de estudios, se incluyeron todos aquellos que presentaran un análisis poblacional. Resultados: El Oswestry Disability Index (ODI) se vio afectado previo al procedimiento en la mayoría de los pacientes intervenidos con la termorizotomía percutánea del NBV, cursando con un puntaje basal de 45,37, el cual fue disminuyendo a los 3 meses a 20,65, 18,6 a los 6 meses, 17,38 a los 9 meses, 18,62 a los 12 meses, 16 a los 24 meses y 17,05 a los 5 años.En cuanto a la escala visual análoga (EVA), el puntaje basal en la población intervenida con termorizotomía del NBV fue de 6,61, 3,56 a los 3 meses, 3,05 a los 6 meses, 2,6 a los 9 meses, 3,06 a los 12 meses, 2,5 a los 24 meses y 2,48 a los 5 años...(AU)

Introduction: Vertebrogenic low back pain is a new concept added to the other pre-existing semiological and pathophysiological forms of pain in this region. It is produced by a lesion in the cartilaginous vertebral plate. As a result of this new concept, novel therapeutic strategies such as percutaneous thermorizotomy of the basivertebral nerve have emerged. Objectives: The main objective of this study is to evaluate the clinical outcomes of patients with a diagnosis of vertebrogenic pain who were treated with percutaneous basivertebral nerve thermorizotomy (BVN). Pain response, functionality and quality of life will be analyzed.Methods: Under the parameters of the PRISMA methodology, a search was performed in the Pubmed and Embase databases with the terms “Intraosseous basivertebral nerve ablation”, “Basivertebral nerve AND Intracept”, “INTRACEPT”, “Intraosseous basivertebral nerve ablation AND Intracept”, “vertebrogenic low back pain”. After the search, the articles were initially reviewed independently by each of the authors, repeated articles were filtered out, obtaining 8 population-based studies. Considering the small number of studies, all those presenting a population analysis were included. Results: The Oswestry Disability Index (ODI) was affected prior to the procedure in most of the patients who underwent percutaneous thermorizotomy of the BVN, with a baseline score of 45.37, which decreased at 3 months to 20.65, 18.6 at 6 months, 17.38 at 9 months, 18.62 at 12 months, 16 at 24 months and 17.05 at 5 years. As for the Visual Analog Scale (VAS), the baseline score in the population treated with NBV thermorizotomy was 6.61, 3.56 at 3 months, 3.05 at 6 months, 2.6 at 9 months, 3.06 at 12 months, 2.5 at 24 months and 2.48 at 5 years. Obtaining similar results to the most recently published systematic review on the subject...(AU)

Interventional Procedures for Vertebral Diseases: Spinal Tumor Ablation, Vertebral Augmentation, and Basivertebral Nerve Ablation-A Scoping Review.

Low back pain is consistently documented as the most expensive and leading cause of disability. The majority of cases have non-specific etiologies. However, a subset of vertebral diseases has well-documented pain generators, including vertebral body tumors, vertebral body fractures, and vertebral endplate injury. Over the past two decades, specific interventional procedures targeting these anatomical pain generators have been widely studied, including spinal tumor ablation, vertebral augmentation, and basivertebral nerve ablation. This scoping review summarizes safety and clinical efficacy and discusses the impact on healthcare utilization of these interventions. Vertebral-related diseases remain a top concern with regard to prevalence and amount of health care spending worldwide. Our study shows that for a subset of disorders related to the vertebrae, spinal tumor ablation, vertebral augmentation, and basivertebral nerve ablation are safe and clinically effective interventions to decrease pain, improve function and quality of life, and potentially reduce mortality, improve survival, and overall offer cost-saving opportunities.

Alleviating Paravertebral Muscle Spasm after Radiofrequency Ablation Treatment of Hypersensitive Basivertebral and Sinuvertebral Nerves for Chronic Discogenic Back Pain.

BACKGROUND: Paraspinal muscle spasm caused by pain from a lumbar degenerative disc is frequently investigated in patients with low back pain. Radiofrequency ablation (RFA) surgery could alleviate paraspinal muscle spasms. OBJECTIVES: We performed RFA surgery on the high-intensity zone (HIZ) and hypersensitive sinuvertebral and basivertebral nerves to evaluate its outcome. The paravertebral muscle cross-sectional area (CSA) was measured on magnetic resonance imaging (MRI) before and after surgery to evaluate the effect of RFA surgery on the paravertebral muscle. STUDY DESIGN: Prospective cohort study. SETTING: A single spine surgery center. METHODS: A comparative study was performed on 2 different uniportal spinal endoscopic surgery groups; 23 patients who underwent RFA surgery for chronic discogenic back pain and 45 patients who underwent posterior decompression surgery for lumbar spinal stenosis with 12 months of follow-up. Paravertebral muscle cross-sectional area, Schiza grade, Modic type, and HIZ size were measured on pre- and post-operative MRI. An endoscopic video review was performed to evaluate the presence of intraoperative twitching and grade the degree of epidural neovascularization and adhesion. Visual analog scale VAS, modified Oswestry Disability Index, ODI and MacNab's criteria were evaluated for outcome measures. RESULTS: Intraoperative endoscopic video evaluation showed neovascularization and adhesion adjacent to the disc and pedicle. In the RFA surgery group, there were 7 patients (30.43%) with grade 2 and 16 (69.57%) with grade 3 neovascularization; intraoperative twitching was observed in 19 out of 23 patients (82.61%). After performing an RFA on the sinuvertebral and basivertebral nerves for the treatment of discogenic back pain, the results showed significant improvement in pain and disability scores. The mean CSA of the paraspinal muscle in the RFA surgery group was significantly increased after surgery at the L4-L5 and L5-S1 levels (L4-L5: 3901 ± 1096.7 mm² to 4167 ± 1052.1 mm², P = 0.000; L5-S1: 3059 ± 968.5 mm² to 3323 ± 1046.2 mm², P = 0.000) compared to preoperative CSA. LIMITATIONS: This study was limited by its small sample size. CONCLUSION: Hypersensitive sinuvertebral and basivertebral nerves are strongly associated with epidural neovascularization with adhesion and the pathological pain pathway in degenerative disc disease. Epidural neovascularization with adhesion reflects aberrant neurological connections, which are associated with reflex inhibitory mechanisms of the multifidus muscle, which induces spasm. RFA treatment of the region of epidural neovascularization with adhesion effectively treated chronic discogenic back pain and could induce paraspinal muscle spasm release.

Developments in Minimally Invasive Surgical Options for Vertebral Pain: Basivertebral Nerve Ablation - A Narrative Review.

Historically, intervertebral disc degeneration has been the etiological target of chronic low back pain; however, disc degeneration is not necessarily directly associated with pain, and many other anatomical structures are potential etiologies. The vertebral endplates have been postulated to be a source of vertebral pain, where these endplates become particularly susceptible to increased expression of nociceptors and inflammatory proliferation carried by the basivertebral nerve (BVN), expressed on diagnostic imaging as Modic changes. This is useful diagnostic information that can help physicians to phenotype a subset of low back pain, which is known as vertebral pain, in order to directly target interventions, such as BVN ablation, to this significant pain generator. Therefore, this review describes the safety, efficacy, and the rationale behind the use of BVN ablation, a minimally invasive spinal intervention, for the treatment of vertebral pain. Our current literature review of available up-to-date publications utilizing BVN ablation in the treatment of vertebral pain suggests that there is limited, but moderate-quality evidence that this is an effective intervention for reduction of disability and improvement in function, at short- and long-term follow-up, in addition to limited moderate-quality evidence that BVN RFA is superior to conservative care for pain reduction, at least at 3-month follow-up. Our review concluded that there is a highly clinical and statistically significant treatment effect of BVN ablation for vertebral pain with clinically meaningful benefits in pain reduction, functional improvements, opioid dose reduction, and improved quality of life. There were no reported device-related patient deaths or serious AEs based on the available literature. BVN ablation is a safe, well-tolerated and clinically beneficial intervention for vertebral pain, when proper patient selection and surgical/procedural techniques are applied.

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

BACKGROUND: Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showed significant differences between arms at 3 and 6-months. At 12-months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24-months. METHODS: Prospective, open label, single-arm follow-up of the BVNA treatment arm of a RCT in 20 US sites with visits at 6-weeks, and 3, 6, 9, 12 and 24-months. Paired comparisons to baseline were made for the BVNA arm at each timepoint for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates. RESULTS: 140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all timepoints through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p < 0.001) and 4.1±2.7 cm (from baseline 6.6; p < 0.001), respectively. A combined responder rate of ODI≥15 and VAS≥2 was 73.7%. A ≥50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3(5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. CONCLUSION: Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain.

Intra-osseous basivertebral nerve radiofrequency ablation (BVA) for the treatment of vertebrogenic chronic low back pain.

STUDY DESIGN: Prospective experimental uncontrolled trial. BACKGROUND: Vertebrogenic pain is a frequently underestimated cause of chronic low back pain (LBP). Vertebral endplate degeneration, characterized by cortical bone damage and subchondral bone inflammatory reaction, is a significant source of LBP, the responsible of the pain transmission being the Basivertebral Nerve (BVN). Radiofrequency ablation of the BVN (BVA) leads to thermal injury of nerve tissue and interruption of the of chronic vertebrogenic pain transmission. PURPOSE: The aim of this study is to evaluate the effectiveness, in terms of pain and disability reduction, of percutaneous (BVA) in treating patients affected by vertebrogenic chronic LBP. Moreover, as a secondary endpoint, the purpose is to assess the feasibility and safety of a percutaneous CT-guided technique. METHODS: We performed percutaneous CT-guided BVN ablation in 56 consecutive patients presenting with vertebrogenic chronic LBP in local anesthesia using an articulating bipolar radiofrequency electrode (STAR™ Tumor Ablation System Merit). A 1-month follow-up MRI was performed to evaluate the ablation area in order to assess the target success of the procedure. A 3-month follow-up CT study was performed to evaluate bone mineral density in order to exclude structural bone abnormalities that might have been induced by the treatment. Pre- and post-procedure pain and disability levels were measured using the visual analogue scale (VAS) and Oswestry Disability Index (ODI). A 2-cm improvement threshold was set as clinical success for the VAS score and a 10-point improvement threshold was set as clinical success for the ODI score. RESULTS: At 3- and 12-month follow-up, VAS and ODI scores decreased significantly compared to baseline. Clinical success was reached in 54/56 patients (96.5%) for pain and 54/56 patients (96.5%) for disability, exceeding significantly the MCID. CT-assisted targeting of the ablation zone was determined successful in 100% of patients. Mean operative time was 32 min. No immediate or delayed complications were detected. CONCLUSIONS: Percutaneous CT-guided intra-osseous BVA seems to be a safe, fast, and powerful technique for pain relief in patients with vertebrogenic chronic LBP, when the selection of patients is based on a multidisciplinary approach including both conventional Diagnostic Radiology and Nuclear Medicine imaging.