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Background Context: Randomized 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)., Purpose: To assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone., Study Design/setting: A model-based economic analysis., Patient Sample: Base 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 Measures: Costs and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER)., Methods: A 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., Results: Base 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., Conclusions: BVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone., Competing Interests: Declaration of competing interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background Context: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined., Purpose: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain., Study Design: PRISMA-compliant systematic review., Patient Sample: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain., Outcome Measures: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI., Methods: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed., Results: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%-70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%-68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%-53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%-88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%-53.2%)., Conclusion: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality., Competing Interests: Declarations of competing interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background Context: Hospitals and policy makers have placed increasing importance on patient satisfaction with medical care. Minimal research exists on patient satisfaction in the context of epidural steroid injections (ESIs) for radicular pain., Purpose: Describe patient satisfaction with ESIs for the treatment of radicular pain and identify patient demographic and clinical characteristics associated with patient satisfaction., Study Design/setting: This was a retrospective study conducted at a large, academic medical center., Methods: This was a single-center retrospective study of prospectively collected registry data including patients treated with ESIs from August 2006 to May 2018. The primary outcomes were: overall Press Ganey (PG) score, patient satisfaction with the physician, and likelihood to recommend both the physician and the practice. Age, body mass index, Charlson Comorbidity Index, immediate change in pain, sex, spinal segmental level of injection, prior opioid use, insurance status, and ethnicity were compared with the four PG measures of satisfaction using both univariable and multivariable regression analysis. No sources of funding were used for this project. The authors report no conflict of interest in relation to this manuscript., Results: Two-hundred ninety patients underwent 377 injections. Overall, patients were highly satisfied; 86% recommend their physician and 85% recommend the practice, each with the highest possible PG score. The median overall PG score was 97.2 (interquartile range [IQR]: 89.3, 100), and the median physician satisfaction score was 100 (IQR: 95, 100). The median immediate reduction in pain was 3 points (IQR: -5,-2) on the numerical rating scale scale postinjection. Increased age was associated with increased satisfaction with the physician (reported rate ratios [Relative Risk (RR)] for dissatisfaction: 0.73, 95% confidence interval [CI]: 0.58, 0.93, p=.011) and increased likelihood to recommend the physician (odds ratio: 1.46, 95% CI: 1.06, 2.01, p=.022) in multivariable analysis. Medicare as opposed to private insurance was associated with higher dissatisfaction with the physician (RR: 2.04, 95% CI: 1.15, 3.61, p=.014) and decreased likelihood to recommend the practice (RR: 0.38, 95% CI: 0.15, 0.94, p=.037)., Conclusions: The present data, based on PG scores, demonstrated that ESIs are associated with greater patient satisfaction with increasing age, but lower satisfaction in patients with Medicare compared with private insurance when controlling for other demographic factors. Satisfaction was not associated with the degree of pain relief., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background Context: Patients with lumbosacral radiculopathy from an intervertebral disc herniation are frequently treated by transforaminal epidural steroid injections (TFESIs). The long-term outcomes of these patients are poorly described., Purpose: We aimed to determine the long-term outcomes for a homogenous group of patients with acute unilateral lumbar radicular pain due to single-level herniated nucleus after lumbar epidural steroid injection at ≥5 years., Design: This is a prospective cohort study., Patient Sample: Subjects enrolled into a previous reported multi-institutional randomized controlled trial, ≥18 years old with single leg radicular pain rating ≥4/10 for less than 6 months' duration, with radiographic imaging demonstrating an anatomically congruent single-level herniated nucleus pulposus., Outcome Measures: Presence of recurrent or persistent pain, pain within the previous week, current opioid use for radicular symptoms, additional spine injections for radicular pain, progression to surgery, and unemployment due to pain as determined by independent phone interview at least 5 years after enrolment due to the initial pain complaint were the outcome measures., Methods: All patients initially underwent a single-level lumbar TFESIs due to failure of conservative care, but could elect to pursue surgical intervention or repeat injections through shared decision making with the treating physician when and if pain control was deemed inadequate. After ≥5 years, an independent assessor contacted the subjects by phone and performed a standardized interview to determine outcomes. Fisher exact test was used to compare outcomes for those who pursued versus those who did not pursue surgery., Results: During the recruitment period (December 2008 to December 2012), 78 subjects were enrolled. At 5 years, 39 (50%) of the 78 subjects were reachable for independent phone follow-up. Of these, 30 (76.9%, 95% confidence interval [CI] 61.7%-87.4%) had a history of recurrent pain since the initial TFESI. However, only 9 (23.1%, 95% CI 12.7%-38.3%) had current pain, while 3 (7.7%, 95% CI 2.7%-20.3%) were currently taking opioid medications. Nine (23.1%, 95% CI 12.7%-38.3%) had received additional TFESIs, and 19 (48.7%, 95% CI 33.9%-63.8%) had received surgery. Only 3 (7.7%, 95% CI 2.7%-20.3%) were unemployed due to related pain at time of follow-up. When comparing the group that had surgery versus those that did not, there were no differences in the rates of recurrent pain (16, 84.2% vs. 14, 70.0%, p=.81), current pain (6, 31.6% vs. 3, 15.0%, p=.47), opioid use (2, 10.5% vs. 1, 5.0%, p=1.00), rate of additional injections (6, 31.6% vs. 3, 15.0%, p=.47), or unemployment status (2, 10.5% vs. 1, 5.0%, p=1.00)., Conclusions: Despite a high success rate at 6 months, the majority of subjects experienced a recurrence of symptoms at some time during the subsequent 5 years. Fortunately, few reported current symptoms, and a small minority required additional injections, surgery, or opioid pain medications. Lumbar disc herniation is a disease that can be effectively treated in the short-term by TFESI or surgery, but long-term recurrence rates are high regardless of treatment received., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: Transforaminal epidural steroid injections (TFESIs) are a commonly used, effective treatment for radicular pain. Accurate delivery of the injected medication helps to ensure maximum therapeutic efficacy and to decrease possible adverse events, and fluoroscopy is the preferred and most common image-guidance modality used to ensure accurate needle placement during lumbar TFESIs. However, fluoroscopic-guided lumbar TFESIs put patients at risk because of radiation exposure. The purpose of this study was to determine the relationship between body mass index (BMI) and fluoroscopy time and radiation dose during lumbar TFESIs., Design: A retrospective study design was used., Setting: The study was conducted at an academic orthopedic center. All procedures were performed by physicians board-certified in Physical Medicine and Rehabilitation (PM&R) and with subspecialty certification in sports medicine, or by a trainee under close supervision from an attending physician., Participants: Participants were patients who underwent fluoroscopic-guided lumbar TFESIs between February 2013 and March 2015 with a documented height/weight, fluoroscopy time, and radiation dose., Interventions: All patients received unilateral or bilateral lumbar TFESIs with fluoroscopic guidance. Fluoroscopy time and dose were recorded., Main Outcome Measures: The main outcome measures were fluoroscopy time and radiation dose. A Bonferroni correction was implemented for multiple comparisons, defining statistical significance at p<.01., Results: A total of 2,443 injections were performed on 1,548 patients. There were 419 normal, 572 overweight, and 557 obese patients, respectively. There were 1,426 first-time injections and 1,017 repeat injections. Sixty-nine percent (1,681) were unilateral injections, and 26.4% (645) were single level injections. A trainee was involved in 1,361 (55.7%) of the injections performed. The mean fluoroscopy time for all injections was 30.0±17.5 seconds, and the mean radiation dose was 2,164±1,484 mGy-cm(2). The mean fluoroscopy time was 27.7±15.2 seconds for normal weight patients, 30.0±21.0 seconds for overweight patients, and 32.2±15.1 seconds for obese patients, showing a significant difference between groups (p<.001). The mean radiation doses for each group were 1,376±450, 1,911±653, and 3,029±640 mGy-cm(2), respectively, with a significant increase in radiation dose with increasing BMI (p<.001)., Conclusions: The findings of this study demonstrate that fluoroscopy radiation dose and fluoroscopy time during lumbar TFESIs are increased in patients with an elevated BMI, and in patients of greater age, but the presence of a trainee had no effect on fluoroscopy time., (Copyright © 2016. Published by Elsevier Inc.)

Background Context: Although the types and incidence of adverse events (AEs) associated with transforaminal epidural steroid injection (TFESI) have been described, no study has used a systematic standardized questionnaire to solicit AEs from patients to capture an accurate range and incidence of complications., Purpose: The aim was to systematically identify the types and incidence of AEs associated with TFESI. Additionally, this study evaluated demographic and clinical factors that may predict a higher risk of an AE., Study Design/setting: This was a retrospective cohort study from a multiphysician academic PM&R clinic., Patient Sample: Patients, aged 19 to 89, who underwent a fluoroscopically guided TFESI for lumbosacral radicular pain between 2004 and 2007 were included., Outcome Measures: The relationship of AEs with gender, age, trainee presence, steroid type, preprocedure visual analog scale (VAS) pain score, systolic blood pressure, fluoroscopy time, and corticosteroid injectate volume was analyzed., Methods: Adverse event data were collected using a survey both immediately and at 24 to 72 hours after TFESI. Statistical analysis was performed using the chi-square, Fisher exact, or Wilcoxon rank sum two-sided tests. Logistic regression analysis was also performed. C.P. is the owner of Rehabilitation Institute of Chicago Physiatric Log & Analysis System computer software., Results: In 1,295 consecutive patients undergoing 2,025 TFESI procedures, immediate AEs and delayed AEs occurred after 182 (9.2%) and 305 (20.0%) injections, respectively. The most common immediate AEs were: vasovagal reaction (4.2%) and interrupted procedure from intravascular flow (1.7%). Common delayed AEs included: pain exacerbation (5.0%), injection site soreness (3.9%), headache (3.9%), facial flushing/sweating (1.8%), and insomnia (1.6%). Significant associations were identified between AEs and gender, age, preprocedure VAS, steroid type, and fluoroscopy time. Trainee involvement in the procedure did not impact the complication rate., Conclusions: Fluoroscopically guided lumbosacral TFESI is associated with a similar rate of minor AEs both immediately and 24 to 72 hours after procedure that are typical of other axial corticosteroid injections. Permanent AEs were not found in this sample. The most common AEs associated with TFESI include vasovagal episodes, procedure interruption from intravascular flow, pain exacerbation, injection site soreness, headache, and insomnia., (Copyright © 2015 Elsevier Inc. All rights reserved.)