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InjectantsEpidural steroid injections usually contain LA and glucocorticoids. The optimal combination and dosing have not been determined. The role of epidural nonsteroidal injections remains controversial. A 2013 systematic review and meta-analysis looked at the control arm of forty-three studies which included saline, LA, and injections into muscle or ligament (sham). In the indirect comparison, they concluded epidural non-steroidal injections achieved positive outcomes (risk ratio, 2.17; 95% CI, 1.87-2.53) and provided greater pain reduction scores (mean difference, -0.15, 95% CI, -0.55 to 0.25). Indirect comparison does not qualify as the same level of evidence as a randomized comparison, and the study was limited by only one included study being ranked as high quality using GRADE methodology and inadequate numbers to detect in effect by size, but suggests that the nonsteroidal injections were not entirely placebo.89 A 2015 systematic review of RCTs using Cochrane review criteria and the American Society of Interventional Pain Physicians (ASIPP) criteria for assessing interventional techniques looked at thirty-one trials seeking evidence on LAs, saline, steroids, and other solutions. They conclude equal efficacy for LA with steroids and LA alone in multiple spinal conditions. For disc herniation, they report superiority of LA with steroids over LA alone.90 A 2021 systematic review of randomized control trials by Manchikanti et al compared sodium chloride solution alone, steroids alone, or sodium chloride solution with steroids in managing spine pain secondary to disc herniation or spinal stenosis. The authors reported utilizing a single-arm analysis that both epidural saline and epidural steroids with saline were effective in reducing 20% of pain, however, only reducing disability score by 10 to 20%.91 Several 2020 systematic reviews and meta-analysis looking at the difference in efficacy between lidocaine alone versus lidocaine and steroids in the management of lumbar disc herniation or spinal stenosis concluded there were similar effects associated with lidocaine alone or in combination with steroids.92,93This study contradicts multiple other studies that showed steroids were superior to saline or other placebos. The Friedly et al multicenter, double-blinded randomized controlled trial compared epidural injections of corticosteroids plus lidocaine versus lidocaine alone in 400 patients with confirmed spinal stenosis. In this study, patients had the option of blinded crossover after six weeks to receive the alternate treatment. However, fewer participants randomized to corticosteroids plus lidocaine (30%, n=60) versus lidocaine alone (45%, n=90) crossed over in six weeks (p=0.03) and 93% indicating a lack of effectiveness as a reason to cross-over. Using an intention-to-treat (ITT) analyses, a small, but consistent difference favoring steroids plus LA over LA alone was observed. At twelve months there was no significant difference between the groups. This study did not show repeat injections of either type offering additional benefit if injections in the first six weeks did not improve pain.62 A systematic review by Bicket et al evaluating control injections in RCTs reports that ESIs may provide a benefit compared to non-ESIs while acknowledging this was based on few, low-quality studies directly comparing controlled treatment and short-term outcomes. However, this review with 3,641 patients from 43 studies represents the largest analysis comparing ESI with a steroid to a nonsteroidal alternative including, LA alone, etanercept, saline, intramuscular or ligamentous injections, and dry needling. The authors concluded the benefit from ESIs was limited but suggested it may not constitute a placebo effect.89While systematic reviews and meta-analysis have suggested a role in non-steroidal injections, these studies are limited because they rely on previously conducted randomized control trials where the research question was not specific to determining the effectiveness of these non-steroid injections. The data set utilized is subject to significant heterogenicity (I2 >50-99%), variability of the patient population, and small sample sizes. Studies dedicated to the investigation of the non-steroid injections are necessary as well as studies with longer-term follow-up periods to understand if there is a role for nonsteroidal injections in lieu of ESIs. There is not enough evidence to be confident that non steroid injections are equally effective to steroid injections based on the current body of literature.A 2016 study reported improvement in pain with particulate compared to non-particulate steroids.94 Spinal cord ischemia and posterior circulation infarction have been reported after cervical ESIs. Concern arose that this risk was greater for particulate compared to non-particulate steroids prompting further investigations and recommendations. In 2011, the FDA required a label change for triamcinolone stating it should not be used for ESI.95 A 2017 systematic review and meta-analysis comparing particulate steroids to non-particulate counterparts conclude that particulate steroids are not better in relieving pain compared to their non-particulate counterparts but may offer an improved safety profile. They conclude with the recommendation to consider switching to non-particulate steroids.96 Another 2017 systematic review by Mehta et al agreed concluding, no benefit to particulate steroids and recommending non-particulate steroids with performing cervical TFESI, with Grade of Recommendation: B. For lumbar TFESI, they state particulate vs. non-particulate as equivocal with Grade of Recommendation: B for pain reduction and C for function with an overall recommendation for non-particulate steroids for lumbar TFESI.97Steroid dosing, dilution, and additives are not standardized and are another area of controversy. There is evidence that different dilutions such as sodium chloride and LA can alter the steroids particle size and distribution. There is concern about the toxicity of additives (such as benzyl alcohol and polyethylene glycol). Based on the potential risk associated with systemic corticosteroid absorption, the WIP Benelux Workgroup recommends using the lowest effective dosing, which amounts to 40 mg for methylprednisolone acetate (MPA), 10-20 mg for triamcinolone acetate, and 10 mg (10mg/mL) for dexamethasone phosphate. They recommend limiting the cervical interlaminar and lumbar transforaminal volume to 4mL and inject slowly.16Etanercept is a soluble p75 tumor necrosis factor fusion protein administered subcutaneously for inflammatory arthritis and other rheumatological conditions. While it has been explored in several studies with preliminary positive results, it is not FDA approved for injection into the epidural space, and therefore is not considered medically reasonable and necessary. Additional agents such as platelet-rich plasma, amniotic fluid, gabapentin, and others have been investigated, but there is not sufficient evidence to support use and they are considered investigational..Multiple ProceduresSince injectants may have a bilateral effect or spread to adjacent levels, diagnostic interlaminar or caudal ESIs are seldom used. Diagnostic TFESIs are sometimes used to determine the level of radicular nerve root pain, to differentiate radicular from non-radicular pain, to evaluate a discrepancy between image studies and clinical findings, to identify the source of pain in the prevalence of multi-level nerve root compression, and to help identify the level of pathology at a previous operative site. Selective spinal nerve blocks (SSNBs) may also be used to identify the source of pain. The cumulative steroid dose and long-term safety has not been studied in the setting of multiple injections administered in the same session.The SMEs were split in terms of multiple procedures during a single session, with half of the experts (6/11) voting that evidence supported the administration of ESIs at the same time as other interventional procedures. However, there was no additional supporting literature provided, and others brought up the concern of lack of diagnostic specificity when multiple procedures are performed in the same session.Society GuidanceNorth American Spine Society (NASS)The 2020 NASS Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain concludes that there is insufficient evidence to make a recommendation for or against the use of caudal or interlaminar epidural steroid injections in patients with low back pain with Grade of Recommendation: I (good evidence for or against recommending intervention).15The 2020 NASS Epidural Steroid Injections and Selective Spinal Nerve Blocks11 offers evidence-based coverage recommendations when possible and in the absence of strict evidence-based criteria recommendations are based on multidisciplinary experience and expertise of the authors. Evidence in this document are not graded. 2ff7e9595c
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