24 research outputs found

    Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines

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    BACKGROUND: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body\u27s own inherent healing armamentarium in the treatment of patient pathology. This therapy\u27s intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public presentation and promises as well as in its use. OBJECTIVE: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine. METHODS: The methodology used has included the development of objectives and key questions. A panel of experts from various medical specialties and subspecialties as well as differing regions collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines. The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences was thoroughly reviewed using a best evidence synthesis of the available literature. The grading for recommendation was provided as described by the Agency for Healthcare Research and Quality (AHRQ). SUMMARY OF EVIDENCE: Lumbar Disc Injections: Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Epidural Injections Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Facet Joint Injections Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Sacroiliac Joint Injection Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. CONCLUSION: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a thorough discussion of the patient\u27s needs and expectations, after properly educating the patient on the use and administration of biologics and in full light of the patient\u27s medical history. Regenerative therapy may be provided independently or in conjunction with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines. KEY WORDS: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration, minimal manipulation, evidence synthesis

    Comprehensive, Evidence-Based, Consensus Guidelines for Prescription of Opioids for Chronic Non-Cancer Pain from the American Society of Interventional Pain Physicians (ASIPP).

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    BACKGROUND: Opioid prescribing in the United States is decreasing, however, the opioid epidemic is continuing at an uncontrollable rate. Available data show a significant number of opioid deaths, primarily associated with illicit fentanyl use. It is interesting to also note that the data show no clear correlation between opioid prescribing (either number of prescriptions or morphine milligram equivalent [MME] per capita), opioid hospitalizations, and deaths. Furthermore, the data suggest that the 2016 guidelines from the Centers for Disease Control and Prevention (CDC) have resulted in notable problems including increased hospitalizations and mental health disorders due to the lack of appropriate opioid prescribing as well as inaptly rapid tapering or weaning processes. Consequently, when examined in light of other policies and complications caused by COVID-19, a fourth wave of the opioid epidemic has been emerging. OBJECTIVES: In light of this, we herein seek to provide guidance for the prescription of opioids for the management of chronic non-cancer pain. These clinical practice guidelines are based upon a systematic review of both clinical and epidemiological evidence and have been developed by a panel of multidisciplinary experts assessing the quality of the evidence and the strength of recommendations and offer a clear explanation of logical relationships between various care options and health outcomes. METHODS: The methods utilized included the development of objectives and key questions for the various facets of opioid prescribing practice. Also utilized were employment of trustworthy standards, and appropriate disclosures of conflicts of interest(s). The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed. The recommendations were developed after the appropriate review of text and questions by a panel of multidisciplinary subject matter experts, who tabulated comments, incorporated changes, and developed focal responses to questions posed. The multidisciplinary panel finalized 20 guideline recommendations for prescription of opioids for chronic non-cancer pain. Summary of the results showed over 90% agreement for the final 20 recommendations with strong consensus. The consensus guidelines included 4 sections specific to opioid therapy with 1) ten recommendations particular to initial steps of opioid therapy; 2) five recommendations for assessment of effectiveness of opioid therapy; 3) three recommendations regarding monitoring adherence and side effects; and 4) two general, final phase recommendations. LIMITATIONS: There is a continued paucity of literature of long-term opioid therapy addressing chronic non-cancer pain. Further, significant biases exist in the preparation of guidelines, which has led to highly variable rules and regulations across various states. CONCLUSION: These guidelines were developed based upon a comprehensive review of the literature, consensus among expert panelists, and in alignment with patient preferences, and shared decision-making so as to improve the long-term pain relief and function in patients with chronic non-cancer pain. Consequently, it was concluded - and herein recommended - that chronic opioid therapy should be provided in low doses with appropriate adherence monitoring and understanding of adverse events only to those patients with a proven medical necessity, and who exhibit stable improvement in both pain relief and activities of daily function, either independently or in conjunction with other modalities of treatments

    Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

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    BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration\u27s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around minimal manipulation and homologous use within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980\u27s and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA\u27s intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption

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

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    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

    Treating Chronic Post Herpetic Neuralgia Using Topical Superconcentrated Capsaicin

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    Post Herpetic Neuralgia (PHN) is a painful condition that occurs after reactivation of the dormant Herpes Zoster Virus.Typically PHN presents with a unilateral rash affecting a single dermatome which is accompanied by burning, irritation, and hypersensitivity for \u3e3 months.Current treatment includes anticonvulsants, tricyclic antidepressants, narcotic/nonnarcotic painkillers, and topical lidocaine. We propose the utilization of a superconcentrated transdermal patch of capsaicin called Qutenza 8%, which is 300 times more potent than current OTC capsaicin. The treatment protocol using Qutenza to treat refractory PHN proposes a novel approach to the treatment of this condition. Capsaicin is commonly known as the active chemical in peppers which is responsible for their spiciness and the pain and irritation associated with ingesting them. The mechanism of action of capsaicin is believed to be release of neurotransmitters upon binding to capsaicin nociceptors, mainly TRPV1. At large doses, capsaicin causes depletion of neurotransmitters and can ultimately lead to nerve fiber denervation. Once the neuron is damaged or depleted of neurotransmitters, pain perception is notably diminished for a period of time thereby effectively providing reliefhttps://corescholar.libraries.wright.edu/urop_celebration/1026/thumbnail.jp

    Equivalent outcomes of lumbar therapeutic facet joint nerve blocks and radiofrequency neurotomy: Comparative evaluation of clinical outcomes and cost utility

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    Background: Chronic low back pain secondary to facet joint pathology is prevalent in 27% to 40% of selected populations using controlled comparative local anesthetic blocks. Lumbar facet joint nerve blocks and radiofrequency neurotomy are the most common interventional procedures for lower back pain. Nonetheless, questions remain regarding the effectiveness of each modality. Moreover, there is no agreement in reference to superiority or inferiority of lumbar facet joint nerve blocks when compared with radiofrequency neurotomy. Centers for Medicare and Medicaid Services (CMS) and almost all payers prefer radiofrequency ablation. Both procedures have been extensively studied with randomized controlled trials, systematic reviews, and cost utility analysis. Objective: To assess the clinical outcomes and cost utility of therapeutic lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) compared with radiofrequency neurotomy in managing chronic low back pain of facet joint origin. Study design: A retrospective, case-control, comparative evaluation of outcomes and cost utility. Setting: The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States. Methods: The study was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology Analysis (STROBE) criteria. Only the patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic local anesthetic blocks were included.The main outcome measure was pain relief measured by the Numeric Rating Scale (NRS) evaluated at 3, 6, and 12 months. Significant improvement was defined as at least 50% improvement in pain relief. Cost utility was calculated utilizing direct payment data for the procedures with the addition of estimated indirect costs over a period of one year based on highly regarded surgical literature and previously published interventional pain management literature. Results: A total of 326 patients met the inclusion criteria with 99 patients receiving lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) and 227 receiving lumbar radiofrequency neurotomy. Forty-eight patients in the facet joint nerve block group and 148 patients in the radiofrequency group completed one-year follow-up. Patients experienced significant improvement in both groups from baseline to 12 months with significant pain relief (≥ 50%) Significant pain relief was recorded in 100%, 99%, and 79% of the patients in the facet joint nerve block group, whereas, it was 100%, 74%, and 65% in the radiofrequency neurotomy group at the 3, 6, and 12 month follow-up, with a significant difference at 6 months. Cost utility analysis showed average costs for quality-adjusted life year (QALY) of 4,664forlumbarfacetjointnerveblocksand4,664 for lumbar facet joint nerve blocks and 5,446 for lumbar radiofrequency neurotomy. Twelve patients (12%) in the lumbar facet joint nerve block group and 79 patients (35%) in the lumbar radiofrequency group were converted to other treatments, either due to side effects or inadequate relief. Conclusion: This study shows similar outcomes of therapeutic lumbar facet joint nerve blocks when compared with radiofrequency neurotomy as indicated by significant pain relief and cost utility

    Steroid distancing in interventional pain management during COVID-19 and beyond: Safe, effective and practical approach

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    Background: Since the late 1940s, corticosteroids have been a mainstay class of agents in multiple interventional techniques and intra-articular injections. Exogenous glucocorticoids are structurally and pharmacologically similar to the endogenous hormones. As such, multiple actions of corticosteroids are exhibited, including those of anti-inflammatory and immunosuppressive effects. Epidural injections, with or without steroids, have been extensively used throughout the world. There are reports of epidural injections starting in 1901, with steroids being added to the local anesthetic since 1952, when steroids were administered into the sacral foramen. Purpose: Due to the extensive side effects of steroids in various injections, some have proposed limiting their use in epidurals and intraarticular injections. With the COVID-19 pandemic, the multiple side effects of the steroids have elevated the level of concern and recommendations have been made to utilize local anesthetic alone or the lowest dose of steroids. Fashioned from common expressions of the day, the term steroid distancing began to be used and proposed for intraarticular injections of the knee. Consequently, we sought to evaluate the evidence and feasibility of steroid distancing in interventional pain management. Methods: This focused review of local anesthetics and steroids utilized in interventional pain management for epidural injections, peripheral nerve blocks, and intraarticular injections by multiple database searches. This is a focused narrative review and not a systematic review. Consequently, evidence synthesis was not performed traditionally, but was based on an overview of the available evidence. Results: No significant difference was identified based on whether steroids are added to local anesthetic or not for epidural as well as facet joint injections. However, there was not enough evidence to compare these two groups for peripheral intraarticular injections. Limitations: The present review is limited by the paucity of literature with bupivacaine alone or bupivacaine with steroids local anesthetic alone or with steroids of intraarticular injections of knee, hip, shoulder and other joints, and intraarticular facet joint injections. Conclusion: This review shows an overall lack of significant difference between lidocaine alone and lidocaine with steroids in epidural injections. However, available evidence is limited for bupivacaine alone or with steroids. Evidence is also not available comparing local anesthetic alone with steroids for facet joint or peripheral joint intraarticular injections. Thus, it is concluded that local anesthetic with lidocaine may be utilized for epidural injections, with appropriate patient selection and steroids reserved for non-responsive patients with local anesthetic and with significant radiculitis

    The influence of Covid-19 on utilization of epidural procedures in managing chronic spinal pain in the medicare population

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    Study design: A retrospective cohort study of utilization patterns and variables of epidural injections in the fee-for-service (FFS) Medicare population. Objectives: To update the utilization of epidural injections in managing chronic pain in the FFS Medicare population, from 2000 to 2020, and assess the impact of COVID-19. Summary of background data: The analysis of the utilization of interventional techniques also showed an annual decrease of 2.5% per 100,000 FFS Medicare enrollees from 2009 to 2018 contrasting to an annual increase of 7.3% from 2000 to 2009. The impact of the COVID-19 pandemic has not been assessed. Methods: This analysis was performed by utilizing master data from the Centers for Medicare and Medicaid Services (CMS), physician/supplier procedure summary from 2000 to 2020. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results: Epidural procedures declined at a rate of 19% per 100,000 Medicare enrollees in the FFS Medicare population in the United States from 2019 to 2020, with an annual decline of 3% from 2010 to 2019. From 2000 to 2010, there was an annual increase of 8.3%. This analysis showed a decline in all categories of epidural procedures from 2019 to 2020. The major impact of COVID-19 with closures taking effect from April 1, 2020, through December 31, 2020, will be steeper and rather dramatic, comparing to April 1 to December 31, 2019. However, monthly data from CMS is not available as of now. Overall declines from 2010 to 2019 showed a decrease for cervical and thoracic transforaminal injections with an annual decrease of 5.6%, followed by lumbar interlaminar and caudal epidural injections of 4.9%, followed by 1.8% for lumbar/sacral transforaminal epidurals, and 0.9% for cervical and thoracic interlaminar epidurals. Conclusion: Declining utilization of epidural injections in all categories was exacerbated to a decrease of 19% from 2019 to 2020 related, in part, to the COVID-19 pandemic. This followed declining patterns of epidural procedures of 3% overall annually from 2010 to 2019. Level of evidence: 4

    Lack of superiority of epidural injections with lidocaine with steroids compared to without steroids in spinal pain: a systematic review and meta-analysis

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    BACKGROUND: Multiple randomized controlled trials (RCTs) and systematic reviews have been conducted to summarize the evidence for administration of local anesthetic (lidocaine) alone or with steroids, with discordant opinions, more in favor of equal effect with local anesthetic alone or with steroids. OBJECTIVE: To evaluate the comparative effectiveness of lidocaine alone and lidocaine with steroids in managing spinal pain to assess superiority or equivalency. STUDY DESIGN: A systematic review of RCTs assessing the effectiveness of lidocaine alone compared with addition of steroids to lidocaine in managing spinal pain secondary to multiple causes (disc herniation, radiculitis, discogenic pain, spinal stenosis, and post-surgery syndrome). METHODS: This systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) for literature search, Cochrane review criteria, and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) to assess the methodologic quality assessment and qualitative analysis utilizing best evidence synthesis principles, and quantitative analysis utilizing conventional and single-arm meta-analysis. PubMed, Cochrane Library, US National Guideline Clearinghouse, Google Scholar, and prior systematic reviews and reference lists were utilized in the literature search from 1966 through December 2019. The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. OUTCOME MEASURES: A hard endpoint for the primary outcome was defined as the proportion of patients with 50% pain relief and improvement in function. Secondary outcome measures, or soft endpoints, were pain relief and/or improvement in function. Effectiveness was determined as short-term if it was less than 6 months. Improvement that lasted longer than 6 months, was defined as long-term. RESULTS: Based on search criteria, 15 manuscripts were identified and considered for inclusion for qualitative analysis, quantitative analysis with conventional meta-analysis, and single-arm meta-analysis. The results showed Level II, moderate evidence, for short-term and long-term improvement in pain and function with the application of epidural injections with local anesthetic with or without steroid in managing spinal pain of multiple origins. LIMITATIONS: Despite 15 RCTs, evidence may still be considered as less than optimal and further studies are recommended. CONCLUSION: Overall, the present meta-analysis shows moderate (Level II) evidence for epidural injections with lidocaine with or without steroids in managing spinal pain secondary to disc herniation, spinal stenosis, discogenic pain, and post-surgery syndrome based on relevant, high-quality RCTs. Results were similar for lidocaine, with or without steroids
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