Predictors of outcome following an epidural steroid injection for disc-related sciatica: a Delphi consensus study.

PURPOSE: Trial data shows modest reductions in leg pain, disability and surgery avoidance following epidural steroid injections (ESI) for severe sciatica. Despite their common use, there is no clear evidence about which patients are more likely to benefit from ESI. The aim of this study was to generate consensus on potential predictors of outcome following ESI for disc-related sciatica. METHODS: A list of potential predictors of outcome was generated during a consensus meeting of seven experts. The items were subsequently presented in a two round on-line Delphi study to generate consensus among experts on which items are potential predictors of outcome. Consensus was defined as 70% agreement among participants. RESULTS: Sixty-one items were generated during the consensus meeting. Of ninety experts invited to participate in the on-line Delphi study, 44 (48%) and 33 (73%) took part in rounds one and two respectively. Twenty-eight additional items suggested by participants in round one were included in round two. Overall, 14 items reached consensus reflecting domains of health, medication use, pain intensity, psychosocial factors, imaging findings and type of injection. CONCLUSION: Based on expert consensus, items that can be routinely collected in clinical practice were identified as potential predictors of outcomes following ESI.

Complications Associated with Lumbar Transforaminal Epidural Steroid Injections.

PURPOSE OF REVIEW: Low back pain with radicular symptoms is a common cause of disability in the adult population in the USA. Lumbar transforaminal epidural steroid injection (TFESI) is one of the most frequently used intervention for lumbar radiculitis. The purpose of this review is to evaluate complications associated with lumbar TFESI. RECENT FINDINGS: Based on the literature review, the reported rate of minor complications was between 2.4 and 9.6%. The major complications including spinal abscess, spinal cord infarct, and epidural hematoma were documented as case reports. Some patients with spinal cord infarct had permanent neurologic deficits, while the other patients had recovery of neurological function after surgical or medical intervention. This review identifies both the minor and major complications related to lumbar transforaminal epidural steroid injections. According to this review, most complications are minor. Lumbar TFESI can be considered a safe treatment in the management of lumbar radicular pain. However, pain specialists should be aware of the potentially devastating major complications. Early recognition and treatment of complications are crucial for improving the outcome.

Lumbar transforaminal epidural steroid injections: does immediate post-procedure pain response predict longer term effectiveness?

OBJECTIVE: To assess whether the immediate anesthetic response of pain relief (sensory blockade) or weakness (motor blockade) after lumbar transforaminal epidural steroid injection (TFESI) is associated with longer term effectiveness in pain relief and functional recovery. DESIGN: Retrospective observational study. SETTING: Single academic radiology practice. SUBJECTS: Three thousand six hundred forty-five lumbar TFESIs performed on 2,634 subjects. METHODS: Subjects completed a pain numerical rating scale (NRS, 0-10) and Roland-Morris disability questionnaire (R-M) prior to and immediately after TFESI (NRS) and at 2 weeks and 2 months follow-up. Successful pain relief was ≥50% NRS reduction; functional success was ≥40% R-M reduction. Post-procedure motor weakness was recorded. Logistic regression models assessed association of immediate post-procedure NRS response, and NRS or R-M response at 2 weeks, with successful outcomes at 2 months. C-index assessed model discrimination; values closer to 1.0 indicated better discrimination. RESULTS: Immediate NRS response was weakly associated with 2-month outcomes (C-index = 0.58). NRS and R-M responses at 2 weeks were more strongly associated with the 2-month response (C-indices 0.77, 0.80, respectively). Post-procedure motor blockade had little association with successful 2-month NRS or R-M outcomes (C-indices 0.51, 0.50, respectively). Patients that responded at 2 weeks were more likely to be responders at 2 months than those who were non-responders at 2 weeks (odds ratio = 6.49, confidence interval 5.38, 7.84). CONCLUSION: Immediate post-TFESI pain relief does not strongly predict longer term effectiveness in pain relief or functional recovery. Response in pain relief or functional recovery at 2 weeks is more strongly associated with 2-month outcomes.

Assessment of Radiation Exposure with Mandatory Two Fluoroscopic Views for Epidural Procedures.

BACKGROUND: Various regulations and practice patterns develop on the basis of Local Coverage Determination (LCD), which are variably perceived as guidelines and/or mandated polices/ regulations. LCDs developed in 2021 and effective since December 2021 mandated a minimum of 2 views for final needle placement with contrast injection which includes both anteroposterior (AP) and lateral or oblique view. Radiation safety has been a major concern for pain physicians and multiple tools have been developed to reduce radiation dose, along with improvement in technologies to limit radiation exposure while performing fluoroscopically guided interventional procedures, with implementation of principles of As Low As Reasonably Achievable (ALARA). The mandated 2 views of epidural injections have caused concern among some physicians, because of the potential of increased exposure to ionizing radiation, despite application of various principles to minimize radiation exposure. Others, including policymakers are of the opinion that it reduces potential abuse and improves safety. OBJECTIVE: To assess variations in the performance of epidural procedures prior to the implementation of the new LCD compared with after the implementation of the new LCD by comparing time and dosage for all types of epidural procedures. STUDY DESIGN: A retrospective, case controlled, comparative evaluation of radiation exposure during epidural procedures in interventional pain management. SETTING: An interventional pain management practice and a specialty referral center in a private practice setting in the United States. METHODS: The study was performed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. The main outcome measure was radiation exposure time measured in seconds and dose measured in mGy-kG2 (milligray to kilogray squared per procedure). RESULTS: Changes in exposure and dose varied by procedural type and location. Exposure time in seconds increased overall by 21%, whereas radiation dose mGy-kG increased 133%. Fluoroscopy time increased most for lumbar interlaminar epidural injections of 43%, followed by 29% for cervical interlaminar epidural injections, 20% for caudal epidural injections, and 14% for lumbar transforaminal epidural injections. In contrast, highest increases were observed in the radiation dose mGy of 191% for caudal epidural injections, followed by 173% for lumbar interlaminar epidural injections, 113% for lumbar transforaminal epidural injections, and the lowest being cervical interlaminar epidural injections of 94%. This study also shows lesser increases for cervical interlaminar epidural injections because an oblique view is utilized rather than a lateral view resulting in a radiation dosage increase of 94% compared to overall increase of 133%, whereas the duration of time of 29% was higher than the overall combined duration of all procedures which only increased by 21%. LIMITATIONS: A retrospective evaluation utilizing the experience of a single physician. CONCLUSION: The results of this study showed significant increases in radiation exposure time and dosage; however, increase of dosage was overall 21% median Interquartile Range (IQR) compared to 133% of radiation dose median IQR. In addition, the results also showed variations for procedure, overall showing highest increases for lumbar interlaminar epidural injections for time (43%) and caudal epidural injections for dosage (191%).

Declining Utilization and Inflation-Adjusted Expenditures for Epidural Procedures in Chronic Spinal Pain in the Medicare Population.

BACKGROUND: Despite epidurals being one of the most common interventional pain procedures for managing chronic spinal pain in the United States, expenditure analysis lacks assessment in correlation with utilization patterns. OBJECTIVES: This investigation was undertaken to assess expenditures for epidural procedures in the fee-for-service (FFS) Medicare population from 2009 to 2018. STUDY DESIGN: The present study was designed to assess expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. In this manuscript: • A patient was described as receiving epidural procedures throughout the year.• A visit was considered to include all regions treated during the visit. • An episode was considered as one treatment per region utilizing primary codes only.• Services or procedures were considered as all procedures including bilateral and multiple levels. A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data for those enrolled in the FFS Medicare program from 2009 to 2018 was utilized. All the expenditures were presented with allowed costs and adjusted to inflation to 2018 US dollars. RESULTS: Total expenditures were $723,981,594 in 2009, whereas expenditures of 2018 were $829,987,636, with an overall 14.6% increase, or an annual increase of 1.5%. However, the inflation-adjusted rate was $847,058,465 in 2009, compared to $829,987,636 in 2018, a reduction overall of 2% and an annual reduction of 0.2%. Inflation-adjusted per patient annual costs decreased from $988.93 in 2009 to $819.27 in 2018 with a decrease of 17.2% or an annual decline of 2.1%. In addition, inflation-adjusted costs per procedure decreased from $399.77 to $377.94, or 5.5% overall and 0.6% annually. Per procedure, episode, visit, and patient expenses were higher for transforaminal epidural procedures than lumbar interlaminar/caudal epidural procedures. Overall, costs of transforaminal epidurals increased 27.6% or 2.7% annually, whereas lumbar interlaminar and caudal epidural injections cost were reduced 2.7%, or 0.3% annually. Inflation-adjusted costs for transforaminal epidurals increased 9.1% or 1.0% annually and declined 16.9 or 2.0% annually for lumbar interlaminar and caudal epidural injections. LIMITATIONS: Expenditures for epidural procedures in chronic spinal pain were assessed only in the FFS Medicare population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans. CONCLUSIONS: After adjusting for inflation, there was a decrease of expenditures for epidural procedures of 2%, or 0.2% annually, from 2009 to 2018. However, prior to inflation, the increases were noted at 14.6% and 1.5%. Inflation-adjusted costs per patient, per visit, and per procedure also declined. The proportion of Medicare patients per 100,000 receiving epidural procedures decreased 9.1%, or 1.1% annually. However, assessment of individual procedures showed higher costs for transforaminal epidural procedures compared to lumbar interlaminar and caudal epidural procedures.

Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines.

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.

A minimum of 5-year follow-up after lumbar transforaminal epidural steroid injections in patients with lumbar radicular pain due to intervertebral disc herniation.

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.