Abstract
Background
The Intracept procedure was the first FDA-cleared technique for basivertebral nerve ablation, a minimally invasive treatment for vertebrogenic chronic low back pain. While prior studies support its effectiveness, data in patients with osteoporosis and osteopenia remains limited.
Objective
To evaluate the safety and effectiveness of basivertebral nerve ablation with a specific focus on pain reduction, functional improvement, and the incidence of post-procedure vertebral compression fractures.
Methods
A retrospective chart review was conducted on patients who underwent the Intracept procedure at our institution from November 2019 to January 2025. Bone density status was categorized using available DEXA scans. Patients were stratified into a Reduced Bone Density group (N = 32), consisting of 23 patients with osteopenia and 9 with osteoporosis, and the overall cohort (N = 134). Pain severity was assessed using the Visual Analog Scale (VAS) at baseline and at the 4–6-week post-procedure follow-up visit, and functional improvement was determined based on patient-reported outcomes at the same time point. Post-procedure complications, including vertebral compression fractures, were monitored until the most recent available follow-up.
Results
A significant decrease in VAS was observed for the overall cohort (7.04 vs. 3.78, p < 0.001) and the Reduced Bone Density group (6.75 vs. 4.13, p < 0.001). Functional improvement was reported by 79.1 % of patients in the overall study population and 78.1 % of patients in the Reduced Bone Density group. No post-procedure vertebral compression fractures were observed in the entire cohort, with a mean follow-up length of 18.07 months.
Conclusion
The Intracept procedure demonstrated significant pain reduction and functional improvement in the overall cohort and in patients with reduced bone density. Notably, no post-procedure vertebral compression fractures were observed, even in patients with osteoporosis and osteopenia. These findings contribute to the growing body of independent literature supporting the safety and effectiveness of the Intracept procedure and offer real-world insight into its use in patients with reduced bone density.
Keywords: Basivertebral nerve ablation, Intracept procedure, Chronic low back pain, Osteoporosis, Osteopenia, Reduced bone density
1. Introduction
Chronic low back pain (CLBP), defined as pain in the lumbar region for 12 weeks or longer, affects an estimated half a billion people worldwide and represents the leading global cause of years lived with disability [1,2]. The prevalence of CLBP is rising due to population growth and aging, with an estimated 843 million prevalent cases expected by 2050 [2]. In the United States, 15.4 % of the workforce reports losing an average of 10.5 workdays annually due to chronic low back pain, totaling roughly 264 million lost workdays [2].
CLBP can arise from damage to the richly innervated vertebral endplates, causing a syndrome known as vertebrogenic low back pain. [3]. Damage and degeneration of these endplates increase communication between the spinal bone marrow and the intervertebral disc, leading to abnormalities that can be felt by the patient and visualized on an MRI as Modic changes (MC) [4]. The presence of MC on MRI correlates with certain clinical symptoms of chronic low back pain; patients typically complain of deep, aching, and burning pain that is worsened by spinal flexion-based movements such as sitting or bending forward [5,6]. Basivertebral nerves (BVNs), which carry nociceptive input to these endplates, have thus been identified as novel therapeutic targets in the treatment of CLBP [7,8]. The Intracept procedure was the first FDA-cleared procedure for BVN ablation, offering a minimally invasive treatment for patients with vertebrogenic CLBP and corresponding MC on MRI [9].
Several studies, including the INTRACEPT trial and the SMART trial, have demonstrated the safety and effectiveness of BVN ablation in the treatment of CLBP, producing significant pain reduction and functional improvement with minimal complications [[10], [11], [12], [13], [14]]. However, these original clinical trials excluded patients with spinal diagnoses such as osteoporosis, scoliosis, severe stenosis, and spondylolisthesis >2 mm [[10], [11], [12], [13], [14]]. The rationale for excluding these patients from the original clinical trials was likely twofold: first, to avoid including patients unlikely to benefit from the procedure (e.g., symptomatic spinal stenosis), and second, to mitigate the theoretical risk of vertebral compression fracture (VCF) in patients with reduced bone density.
Initial questions regarding the safety of BVN ablation in patients with reduced bone density stem from the findings of Fogel et al., who in 2024 reported 8 VCFs in a cohort of 74 patients who underwent BVN ablation within one year. The VCFs all occurred in patients with osteoporosis, contributing to ongoing uncertainty surrounding the safety of BVN ablation in this patient population [15].
More recently, Schnapp et al. conducted an independent study with less stringent exclusion criteria than the original clinical trials, explicitly excluding only patients with severe cardiac or pulmonary disease or active systemic or localized infection at the treatment site. Patients were not screened for osteoporosis and were not excluded based on spinal diagnoses such as spinal stenosis, radiculopathy, or scoliosis. Despite broader selection criteria, 77.4 % of patients experienced at least a 2-point reduction in VAS [15]. Together, these findings illustrate the importance of continually reevaluating patient selection criteria and indicate an opportunity to explore the safety and effectiveness of BVN ablation in patients with reduced bone density, a group largely excluded from prior studies.
According to data from the 2010 National Health and Nutrition Examination Survey, 53.6 million Americans aged 50 and older—representing 43.9 % of that age group—had either osteoporosis or low bone mass [16]. Given the high prevalence of reduced bone density in an aging population—one that is also expected to experience increasing rates of CLBP, there is a critical need to study the safety and effectiveness of BVN ablation in patients with reduced bone density. Many prior clinical trials evaluating BVN ablation, including the SMART trial and the INTRACEPT trial, received industry sponsorship [10,14]. In contrast, this investigator-initiated study was conducted without external funding or industry involvement, providing objective real-world data. The goal of this study was to evaluate the safety and effectiveness of BVN ablation in a cohort of patients with varying bone density, including those with osteopenia and osteoporosis.
2. Methods
2.1. Ethics statement
This retrospective chart review study was approved by the Stony Brook University Hospital Committee on Research in Human Subjects via a waiver of consent (IRB2025-00033).
2.2. Subject selection and patient group designation
Adult patients (age ≥18) who underwent the Intracept procedure at our institution from November 2019 to January 2025 were included in this retrospective chart review study. A total of 134 eligible patients were identified within the study period. Patient demographics, baseline clinical characteristics, and outcome data were extracted from the electronic medical record (EMR). Bone density status was categorized using available DEXA scans. Patients were stratified into a Reduced Bone Density group (N = 32), consisting of 23 patients with osteopenia and 9 with osteoporosis. Five patients had normal bone density confirmed by DEXA, while 97 patients did not have available DEXA scans. Due to the limited number of patients with confirmed normal bone density (N = 5), statistical comparisons between groups were not performed.
2.3. Clinical and procedural data collection
Demographics, baseline clinical characteristics, and intra-procedure data for all included patients were extracted from the EMR. Intra-procedure data included the number of vertebral levels treated, anesthesia used, and ablation parameters. Additionally, the number of attempts to access the vertebral body and reach the ablation target was recorded to assess the risk associated with multiple instrument passes through the vertebral body. Pain severity was assessed using the Visual Analog Scale (VAS) at baseline and again at the 4–6-week post-procedure follow-up visit, and functional improvement was determined based on documented patient-reported outcomes at the same time point. During this follow-up visit, patients were typically asked about their ability to perform daily activities, including walking, standing, sitting, bending, and returning to work or hobbies. Functional improvement was defined as any clinical documentation of increased activity levels, enhanced mobility, return to work, or general improvement in performing activities of daily living as recorded in the clinical notes at the 4–6-week follow-up visit. The 4–6-week follow-up visit was selected as it aligns with standard follow-up practices and assessment of early clinical improvement at our institution, allowing for standardization of outcome data collection for all patients in the study. Post-procedure complications, including vertebral compression fractures, were monitored until the most recent available follow-up. Patients were monitored for vertebral compression fractures based on clinical evaluation at follow-up appointments; routine post-procedure imaging was not performed. The length of follow-up was recorded for each patient. Primary outcome measures included the change in VAS, patient-reported functional status, and the occurrence of post-procedure vertebral compression fractures.
2.4. Statistical analysis
All statistical analyses were performed using IBM SPSS Statistics 26™ (IBM Corp.). Two-sided P values ≤ 0.05 were considered statistically significant. We utilized chi-square tests and Fisher's exact tests for categorical variables and independent samples t-tests or Mann-Whitney tests for continuous variables.
3. Results
3.1. Demographics of the overall cohort and Reduced Bone Density Group
Patient demographic data are presented in Table 1. The mean age was 69.80 years in the overall cohort and 75.53 years in the Reduced Bone Density Group. 84.4 % of patients in the Reduced Bone Density Group were female, compared to 46.3 % of patients in the overall cohort. 93.8 % of patients in the Reduced Bone Density Group were insured by Medicare, compared to 76.9 % of patients in the overall cohort.
Table 1.
Demographics of the total patient population and reduced bone density group.
| All Patients (N = 134) | Reduced Bone Density Group (N = 32) | |
|---|---|---|
| Age (Years), Mean ± SD (Range) | 69.80 ± 11.43 (36–90) | 75.53 ± 6.41 (59–89) |
| Sex | ||
| Male | 72 (53.7 %) | 27 (84.4 %) |
| Female | 62 (46.3 %) | 5 (15.6 %) |
| BMI (Mean ± SD) | 28.93 ± 5.20 | 28.20 ± 6.05 |
| Obese | 48 (35.8 %) | 11 (34.4 %) |
| Smoking History | 75 (56.0 %) | 16 (50.0 %) |
| Diabetes History | 19 (14.2 %) | 6 (18.3 %) |
| Race | ||
| Black or African American | 2 (1.5 %) | 1 (3.1 %) |
| Unknown/Prefer Not to Say | 1 (0.7 %) | 0 (0.0 %) |
| White | 131 (97.8 %) | 31 (96.9 %) |
| Ethnicity | ||
| Hispanic or Latino | 1 (0.7 %) | 0 (0.0 %) |
| NOT Hispanic or Latino | 128 (95.5 %) | 100 (100.0 %) |
| Unknown/Prefer Not to Say | 5 (3.7 %) | 0 (0.0 %) |
| Insurance Status | ||
| Private Insurance | 19 (14.2 %) | 1 (3.1 %) |
| Medicare | 103 (76.9 %) | 30 (93.8 %) |
| Medicaid | 2 (1.5 %) | 0 (0.0 %) |
| Veterans Affairs (VA) | 1 (0.7 %) | 0 (0.0 %) |
| Worker's Comp | 5 (3.7 %) | 1 (3.1 %) |
| No Fault/MVA | 4 (3.0 %) | 0 (0.0 %) |
3.2. Baseline clinical characteristics of the overall cohort and Reduced Bone Density Group
Baseline clinical characteristics are presented in Table 2. The mean baseline VAS for the overall cohort was 7.04, compared to 6.75 for the Reduced Bone Density group. Long-term opioid use prior to the procedure was reported in 8.2 % of the overall cohort (11 patients) and 15.6 % of the Reduced Bone Density Group (5 patients).
Table 2.
Baseline clinical characteristics of the total patient population and reduced bone density group.
| All Patients (N = 134) | Reduced Bone Density Group (N = 32) | |
|---|---|---|
| Baseline Visual Analog Scale (Mean ± SD) | 7.04 ± 2.18 | 6.75 ± 2.23 |
| Opioid Use at Baseline | 11 (8.2 %) | 5 (15.6 %) |
| Duration of Low Back Pain in Years (Mean ± SD) | 8.31 ± 18.08 | 7.24 ± 6.92 |
| Bone Density Status | ||
| Normal Bone Density | 5 (3.7 %) | 0 (0.0 %) |
| Osteopenia | 23 (17.2 %) | 23 (71.9 %) |
| Osteoporosis | 9 (6.7 %) | 9 (28.1 %) |
| Not Assessed | 97 (72.4 %) | 0 (0.0 %) |
| Treatment with Osteopenia/Osteoporosis Medications | 6 (4.5 %) | 6 (18.8 %) |
| Presence of Pre-Procedure Compression Fracturesa | 8 (6.0 %) | 4 (12.5 %) |
All pre-existing vertebral compression fractures were located at levels not treated with the Intracept Procedure.
3.3. Intraoperative data for the overall cohort and Reduced Bone Density Group
Intraoperative data are presented in Table 3. The median number of vertebral levels treated was 3.5 for both groups. No patients required multiple attempts to access the vertebral body and reach the ablation target, and ablation parameters were 85 °C for 15 min for all patients in the study (see Fig. 1).
Table 3.
Intraoperative data from the total patient population and reduced bone density group.
| All Patients (N = 134) | Reduced Bone Density Group (N = 32) | |
|---|---|---|
| Median Number of Levels Treated (IQR) | 3.5 (2, 5) | 3.5 (2, 5) |
| Median Number of Attempts at Vertebral Body Accessa | 1 | 1 |
| Type of Anesthesia Used | ||
| General | 132 (98.5 %) | 31 (96.9 %) |
| MAC and Local | 2 (1.5 %) | 1 (3.1 %) |
| Ablation Parameters Used | ||
| 85 Degrees Celsius for 15 min | 134 (100.0 %) | 32 (100.0 %) |
No patients required multiple attempts at vertebral body access.
Fig. 1.
Patient categorization flowchart.
Flowchart describing the patient population that underwent basivertebral nerve ablation at the Stony Brook Center for Pain Management from November 2019 to January 2025.
3.4. Outcomes and complications for the overall cohort and Reduced Bone Density Group
Table 4 illustrates patient-reported outcome data at the 4–6-week follow-up visit for the overall cohort and the Reduced Bone Density group. A statistically significant decrease in VAS was observed for the overall cohort (7.04 vs. 3.78, p < 0.001) and the Reduced Bone Density group (6.75 vs. 4.13, p < 0.001). Fig. 2 illustrates the change in VAS for the overall cohort, and Fig. 3 shows the change in VAS for the Reduced Bone Density group. Functional improvement was reported by 79.1 % of patients in the overall cohort and 78.1 % of patients in the Reduced Bone Density group. The number of patients taking opioids in both the overall cohort and the Reduced Bone Density group was unchanged at the 4–6-week follow-up visit compared to baseline use. Table 5 illustrates the incidence of complications, which were monitored until the most recent available follow-up visit, and follow-up duration for the overall cohort and the Reduced Bone Density group. No post-procedure vertebral compression fractures were observed in the entire cohort, with a mean follow-up length of 18.07 months. Four complications were reported by patients in the overall cohort, including left foot drop, transient lower extremity muscle spasms, paraspinal muscle spasms, and left foot paresthesia, all of which resolved by the end of follow-up. No complications were reported in the Reduced Bone Density group, which had a mean follow-up length of 17.91 months.
Table 4.
Patient-reported outcomes at 4–6 Weeks post-procedure.
| All Patients (N = 134) | Reduced Bone Density Group (N = 32) | |
|---|---|---|
| Follow-up Visual Analog Scale (Mean ± SD) | 3.78 ± 2.23 | 4.12 ± 2.49 |
| Decrease in VAS (Mean ± SD) | 3.27 ± 2.61 | 2.62 ± 2.23 |
| % Decrease in VAS (Mean ± SD) | 41.56 ± 56.21 | 40.75 ± 31.59 |
| ≥50 % Decrease in VAS | 68 (50.7 %) | 12 (37.5 %) |
| Patients with ≥ 2-Point VAS Decrease | 100 (74.6 %) | 20 (62.5 %) |
| Reported Improvement in Functional Status | 106 (79.1 %) | 25 (78.1 %) |
| Self-Reported % Pain Reduction (Mean ± SD) | 57.28 % ± 30.12 | 55.16 % ± 31.02 |
| Post-Procedure Opioid Use | 11 (8.2 %) | 5 (15.6 %) |
Fig. 2.
Change in VAS Before and After Intracept Procedure for the Overall Cohort. ∗∗∗ indicates p < 0.001.
Fig. 3.
Change in VAS Before and After Intracept Procedure for the Reduced Bone Density Group. ∗∗∗ indicates p < 0.001.
Table 5.
Long-term safety outcomes and follow-up duration.
| All Patients (N = 134) | Reduced Bone Density Group (N = 32) | |
|---|---|---|
| Post-Procedure Complications | 4 (3.2 %) | 0 (0.0 %) |
| Post-Procedure Compression Fractures | 0 (0.0 %) | 0 (0.0 %) |
| Length of Follow-Up Period (Months), Mean ± SD (Range) | 18.07 ± 11.71 (2, 51) | 17.91 ± 12.93 (3, 49) |
| Length of Follow-Up Period (Months), Median (IQR) | 15.5 (17) | 16 (19.25) |
4. Discussion
This study evaluated the safety and effectiveness of BVN ablation in a cohort of patients with varying bone density, including those with osteopenia and osteoporosis. We performed a retrospective EMR review of all adult patients who underwent the Intracept procedure at our institution from November 2019 to January 2025. Demographic data, baseline clinical characteristics, intraoperative data, outcomes, and complications were analyzed for the full cohort and for a subset of patients with reduced bone density (N = 32), which included 23 patients with osteopenia and 9 with osteoporosis.
4.1. Effectiveness of BVN ablation across varying bone densities
We observed a statistically significant reduction in VAS for the overall cohort and the Reduced Bone Density Group. Additionally, 79.1 % of patients in the overall cohort and 78.1 % of patients in the Reduced Bone Density Group reported improvement in their functional status. There was no change in opioid use status in our population after the procedure, which may reflect the relatively low prevalence of opioid use in our population as compared to prior BVN ablation studies (8.6 % in our overall cohort as compared to, e.g., 30 % of patients in the SMART trial) [12]. The mean decrease in VAS for our overall cohort was 3.27 and 2.62 for patients in the Reduced Bone Density group at 4–6 weeks post-procedure, which is comparable to outcomes reported in the original clinical trials of BVN ablation. The SMART trial reported a mean VAS decrease of 2.97 at 3 months post-procedure, and the INTRACEPT trial reported a mean VAS decrease of 3.46 at 3 months post-procedure [10,14]. Additionally, 74.6 % of patients in our overall cohort experienced a ≥ 2-point VAS decrease at the 4–6-week follow-up visit, compared to 72.5 % of patients in the INTRACEPT trial at 3 months post-procedure [14]. These findings suggest that the clinical benefit of BVN ablation at 4–6 weeks post-procedure in our cohort is consistent with improvements reported at 3 months post-procedure in prior trials, supporting the procedure's effectiveness even at 4–6 weeks post-procedure.
While several prior studies demonstrated significant reductions in pain and improvements in functional status for patients undergoing BVN ablation, questions have remained regarding the generalizability of these results to patients with reduced bone density. The SMART trial excluded patients with osteoporosis as defined by T-score < −2.5, and the INTRACEPT trial excluded patients with metabolic bone disease, spine fragility, or history of vertebral compression fractures [10,14]. As a result, patients with reduced bone density have been underrepresented in the literature on BVN ablation. Schnapp et al. did not screen patients for osteoporosis in their study and given the mean age of 73.0 years for their cohort, a subset of patients in their study likely had underlying osteopenia or osteoporosis [15,17]. While their findings support the broader applicability of BVN ablation, our results further suggest that reduced bone density may not preclude meaningful clinical improvement following BVN ablation. Larger studies can continue to refine our understanding of BVN ablation outcomes in this patient population as patient selection criteria continue to be optimized.
4.2. Implications of age in patient selection
The mean age of our cohort was 69.80 years, which was substantially older than cohorts in prior studies. Earlier studies included younger, healthier cohorts, generating questions regarding the generalizability of these results to older populations. For instance, the mean age of the cohort in the SMART trial was 47 years, and the mean age of the cohort in the INTRACEPT trial was 50 years [10,14]. Notably, the independent study conducted by Schnapp et al. demonstrated clinical improvement after Intracept in an older patient population, with a mean age of 73.0 years [15]. Our findings reinforce the results of the Schnapp study, suggesting that advanced age is not a barrier to meaningful clinical improvement after BVN ablation, and that the procedure is likely to benefit patients across a broader age range than was initially demonstrated in early clinical trials.
4.3. Safety and risk of vertebral compression fractures
Expansion of BVN ablation to older patients, potentially with reduced bone density, raises important safety concerns, namely the risk of vertebral compression fractures (VCFs). In 2024, Fogel et al. reported 8 patients with vertebral compression fractures in a cohort of 74 patients undergoing BVN ablations during a one-year period. All 8 patients who experienced VCF in this study had osteoporosis, and the mean age of these patients was 78 years. The authors acknowledged that, in at least one patient, the VCF was likely related to the patient's preexisting osteoporosis rather than the BVN ablation itself, and it was diagnosed incidentally following the procedure. Notably, some of the VCFs occurred at untreated levels or directly adjacent to prior spinal fusion surgery or kyphoplasty, with VCF occurring at a mean interval of 69 days post-procedure [18].
In contrast, although 8 patients in our study had pre-existing VCFs, including 4 patients in the Reduced Bone Density group, there were no reported new VCFs in our cohort of 134 patients (32 of whom had osteopenia or osteoporosis). Importantly, our cohort was followed for a mean interval of 18.07 months, exceeding the timeframe in which post-BVN ablation VCFs have been reported in prior studies. In our cohort, the ablation target was successfully accessed via a single pass through the vertebral body for each vertebral level treated. This consistency in technique may have contributed to the favorable safety profile in our cohort. When performed with controlled vertebral body entry and precise targeting of the ablation site, BVN ablation appears to be a safe procedure that does not confer an increased risk of VCF, even in elderly patients and those with reduced bone density.
4.4. Early onset of clinical improvement
Notably, we observed clinically meaningful improvement in both pain and functional status as early as 4–6 weeks post-procedure. While early clinical improvement is expected after an ablative procedure, most published studies on BVN ablation have focused on longer-term follow-up intervals, such as 3, 6, or 12 months [10,13,14]. Our findings reinforce that patients may experience clinically significant improvement in the first 4–6 weeks following the procedure, which may be helpful in counseling patients and guiding post-procedure follow-up. Patients may continue to experience additional improvement beyond the 4–6-week follow-up period, as demonstrated in prior studies [12]. Further studies can continue to fully elucidate the trajectory of pain reduction and functional improvement following BVN ablation.
4.5. Limitations
Our cohort of 134 patients provides a relatively large sample size compared to prior studies on basivertebral nerve ablation, but certain limitations remain. As a retrospective analysis, our findings are subject to the inherent limitations of observational study design. DEXA scan data was unavailable for 97 of the 134 patients in our cohort, which limited our ability to stratify bone density across the entire cohort. As a result, the true prevalence of osteopenia and osteoporosis is likely higher than reported. Only 5 patients had normal bone density confirmed by DEXA scan data, preventing statistical comparisons between patients with and without reduced bone density. While our study only assessed VAS scores and functional status at the 4–6-week follow-up visit, post-procedure complications (including VCFs) were monitored via clinical evaluation until the most recent available follow-up, with a mean follow-up length of 18.07 months. However, routine post-procedure imaging was not performed for all patients, so the possibility of asymptomatic vertebral compression fractures cannot be ruled out. Future studies will continue to refine our understanding of long-term outcomes and expand applicability to broad patient cohorts beyond those included in early clinical trials.
5. Conclusions
In this retrospective cohort study, we found that BVN ablation demonstrated significant pain reduction and functional improvement in the overall study population and in patients with reduced bone density. Notably, no post-procedure vertebral compression fractures were observed, even in patients with osteopenia and osteoporosis. Our patient population was considerably older than cohorts in prior studies, suggesting that advanced age is not a barrier to positive clinical outcomes after BVN ablation. A key strength of this study is its independence, as it was conducted without industry sponsorship and received no external funding. Our study contributes objective real-world data to the growing body of evidence supporting BVN ablation in a broad population of patients with chronic low back pain, including those with osteopenia or osteoporosis.
CRediT authorship contribution statement
Emily Bellow: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Visualization, Writing - Original Draft, Writing - Review & Editing. Derek Johnson: Data Curation, Formal Analysis, Investigation, Methodology, Visualization, Writing - Original Draft, Writing - Review & Editing. Sandi Bajrami: Formal Analysis, Investigation, Methodology, Visualization, Writing - Original Draft, Writing - Review & Editing. William Caldwell: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing - Original Draft, Writing - Review & Editing.
Funding statement
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of competing interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:William Caldwell reports a relationship with Boston Scientific Corporation that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgements
We would like to thank the Stony Brook Center for Pain Management and the Department of Anesthesiology for their role in patient care and their support of our research.
Data availability
Investigators can contact the corresponding author to request access to de-identified clinical data in this study.
References
- 1.Violante F.S., Mattioli S., Bonfiglioli R. Low-back pain. Handb Clin Neurol. 2015;131:397–410. doi: 10.1016/B978-0-444-62627-1.00020-2. [DOI] [PubMed] [Google Scholar]
- 2.GBD 2021 Low Back Pain Collaborators Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5:e316–e329. doi: 10.1016/S2665-9913(23)00098-X. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Fields A.J., Liebenberg E.C., Lotz J.C. Innervation of pathologies in the lumbar vertebral end plate and intervertebral disc. Spine J. 2014;14:513–521. doi: 10.1016/j.spinee.2013.06.075. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Dudli S., Sing D.C., Hu S.S., Berven S.H., Burch S., Deviren V., et al. ISSLS prize in basic science 2017: Intervertebral disc/bone marrow cross-talk with Modic changes. Eur Spine J. 2017;26:1362–1373. doi: 10.1007/s00586-017-4955-4. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Francio T., Sherwood V., Twohey D. Developments in minimally invasive surgical options for vertebral pain: basivertebral nerve ablation - a narrative review. J Pain Res. 2021;14:1887–1907. doi: 10.2147/JPR.S287275. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Sayed D., Naidu R.K., Patel K.V., Strand N.H., Mehta P., Lam C.M., 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. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Bailey J.F., Liebenberg E., Degmetich S., Lotz J.C. Innervation patterns of PGP 9.5-positive nerve fibers within the human lumbar vertebra: PGP 9.5 fibers in the human lumbar vertebra. J Anat. 2011;218:263–270. doi: 10.1111/j.1469-7580.2010.01332.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Urits I., Noor N., Johal A.S., Leider J., Brinkman J., Fackler N., et al. Basivertebral nerve ablation for the treatment of vertebrogenic pain. Pain Ther. 2021;10:39–53. doi: 10.1007/s40122-020-00211-2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Lee E., Kim J., Rahman S., Daksla N., Caldwell W., Bergese S. Basivertebral nerve ablation for treatment of lower back pain. Biomedicines. 2024;12:2046. doi: 10.3390/biomedicines12092046. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Fischgrund J.S., Rhyne A., Franke J., Sasso R., Kitchel S., Bae H., 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;27:1146–1156. doi: 10.1007/s00586-018-5496-1. [DOI] [PubMed] [Google Scholar]
- 11.Fischgrund J.S., Rhyne A., Franke J., Sasso R., Kitchel S., Bae H., 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;13:110–119. doi: 10.14444/6015. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Fischgrund J.S., Rhyne A., Macadaeg K., Moore G., Kamrava E., Yeung C., 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;29:1925–1934. doi: 10.1007/s00586-020-06448-x. [DOI] [PubMed] [Google Scholar]
- 13.Truumees E., Macadaeg K., Pena E., Arbuckle J., 2nd, Gentile J., 2nd, Funk R., 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;28:1594–1602. doi: 10.1007/s00586-019-05995-2. [DOI] [PubMed] [Google Scholar]
- 14.Khalil J.G., Smuck M., Koreckij T., Keel J., Beall D., Goodman B., et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19:1620–1632. doi: 10.1016/j.spinee.2019.05.598. [DOI] [PubMed] [Google Scholar]
- 15.Schnapp W., Schnapp M., Gottlieb J., Alexandre L.C., Martiatu K., Delcroix G.J.-R. Prospective cohort study of basivertebral nerve ablation for chronic low back pain in a real-world setting: 12 months follow-up. Interv Pain Med. 2024;3 doi: 10.1016/j.inpm.2024.100446. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Wright N.C., Looker A.C., Saag K.G., Curtis J.R., Delzell E.S., Randall S., et al. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014;29:2520–2526. doi: 10.1002/jbmr.2269. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.Salari N., Darvishi N., Bartina Y., Larti M., Kiaei A., Hemmati M., et al. Global prevalence of osteoporosis among the world older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2021;16:669. doi: 10.1186/s13018-021-02821-8. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Fogel G., Musie J., Phillips T.R., Shonnard M., Youssef S., Hirsch J.A., et al. Assessment and management of patients developing low energy vertebral compression fractures following basivertebral nerve ablation. Pain Med. 2024;25:249–251. doi: 10.1093/pm/pnad132. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Investigators can contact the corresponding author to request access to de-identified clinical data in this study.