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Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression., Study Design: Prospective, multi-center, randomized controlled clinical trial., Setting: Twenty-six US interventional pain management centers., Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy., Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only., Outcome Measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group., Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00)., Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies., Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population., Clinical Trial Registration: NCT02093520.

Neurological and other complications of epidural steroid injections have been widely discussed in recent years. Consequently, the US FDA issued a warning about serious neurological events, some resulting in death, and consequently is requiring label changes. Neurological adverse events numbering 131, including 41 cases of arachnoiditis, have been identified by the FDA, and 700 cases of fungal meningitis following injection of contaminated steroids. A review of the literature reveals an overwhelming proportion of the complications are related to transforaminal epidural injections, with the majority of them to cervical transforaminal epidural injections. This perspective describes the prevalence of administering epidural injections, complications, pathoanatomy, mechanism of injury and various preventive strategies.

Background: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. However, all modalities of treatments are directed towards disc herniation which is responsible for a very small proportion of the patients. Thus, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain including surgery and epidural injections including surgery, intradiscal therapies, and epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of all modalities treatments in managing axial or discogenic pain in the lumbar spine., Study Design: A randomized, double-blind, active control trial., Setting: A private practice, specialty referral, interventional pain management practice in the United States., Objectives: To evaluate the ability to assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids., Methods: In this study, a total of 120 patients were randomly allocated to one of the 2 groups receiving either local anesthetic alone or local anesthetic with steroids with 60 patients in each group. The primary outcome measure was at least 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment., Results: Significant pain relief and functional status improvement defined as at least 50% or more reduction in scores from baseline were observed in 72% of patients receiving local anesthetic alone and 67% of the patients receiving local anesthetic with steroids. Opioid intake was reduced from baseline in each group for 2 years., Limitations: The results of the study are limited by the lack of a placebo group., Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis., Trial Registration: NCT00681447.

Background: Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on their effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular., Study Design: A systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis., Objective: To evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain emanating as a result of disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain., Methods: The available literature on caudal epidural injections with or without steroids in managing various types of chronic low back pain with or without lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for fluoroscopic observational studies. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles., Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized., Results: For this systematic review, 73 studies were identified. Of these, 51 were excluded and a total of 16 studies met inclusion criteria for methodological quality assessment with 11 randomized trials and 5 non-randomized studies. For lumbar disc herniation, the evidence is good for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. In managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome, the indicated evidence is fair., Limitations: The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation., Conclusion: There was good evidence for short- and long-term relief of chronic pain secondary to disc herniation or radiculitis with local anesthetic and steroids and fair relief with local anesthetic only. Further, this systematic review also provided indicated evidence of fair for caudal epidural injections in managing chronic axial or discogenic pain, spinal stenosis, and post surgery syndrome.

Background: The proportion of patients suffering from thoracic pain secondary to thoracic disorders is relatively small compared to low back and neck pain. Furthermore, thoracic interventions are not performed as often as in cervical and lumbar regions. In addition, there is a paucity of literature regarding thoracic intervertebral discs and thoracic disc herniation as causative structures of thoracic pain., Study Design: A randomized, double-blind, active controlled trial., Setting: A private practice, interventional pain management and specialty referral center in the United States., Objectives: To evaluate the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief in managing chronic mid and upper back pain secondary to disc herniation or radiculitis and discogenic pain with local anesthetic alone or with steroids., Methods: Inclusion criteria consisted of patients who either had disc herniation or radiculitis, or patients with discogenic pain proven by controlled comparative local anesthetic blocks not to be caused by facet joint pain. Patients were assigned to one of 2 groups. One group received injections containing local anesthetic only; the other group, local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization., Outcomes Assessment: Participant outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of >/= 50% of NRS scores and Oswestry scores were considered significant., Results: A total of 40 participants are included in this preliminary report with 20 participants in each group. Significant pain relief (>/= 50%) and reduction (by at least 50%) in ODI from baseline was seen at 12 months in 80% of patients in Group I and 85% in Group II., Limitations: This is a preliminary report and there was no placebo group. Overall, 80% of participants in Group I (who received injections without steroids) and 85% in Group II (who received injections with steroids) with thoracic pain secondary to disc herniation or radiculitis and discogenic pain might benefit from thoracic interlaminar epidural injections., Clinical Trial: NCT01071369.

Background: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with longterm followups. Methods: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV). Results: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple highquality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone. Conclusion: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone. [ABSTRACT FROM AUTHOR]

Epidural administration of corticosteroids is one of the commonly used interventions in managing low back pain with or without radiculopathy. Approaches used to access the lumbar epidural space include the caudal, interlaminar, and transforaminal injections. Reports of effectiveness have varied from 18% to 90%. However, most of the analyses have failed to separate the three approaches, not only mixing the various procedures but also results and outcomes. Recent guidelines by the American Society of Interventional Pain Physicians and others have evaluated effectiveness of caudal epidural steroid injections (ESIs), transforaminal, and interlaminar injections separately. The consensus from these reviews is that caudal ESIs are superior to the interlaminar epidural injections and equal to transforaminal epidural injections. In addition, the response to epidural injections for various pathologic conditions (disc herniation and/or radiculitis, discogenic pain without disc herniation, spinal stenosis, postsurgery syndrome) is variable. The systematic reviews indicated Level I evidence for caudal ESIs in managing disc herniation or radiculitis, and discogenic pain without disc herniation or radiculitis. They also indicated evidence is Level II-1 or II-2 evidence for caudal epidural injections in managing pain of postlumbar surgery syndrome and lumbar spinal stenosis. They also provided strong recommendations of 1B or 1C for caudal ESIs in managing pain secondary to disc herniation and radiculitis, or discogenic pain without disc herniation or radiculitis, postlumbar laminectomy syndrome, and spinal stenosis. [Copyright &y& Elsevier]