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Chronic pain management during the coronavirus disease 2019 (COVID-19) pandemic is a challenging process, especially with growing evidence that COVID-19 infection is associated with myalgias, referred pain, and widespread hyperalgesia. In light of the limited data available for COVID-19-related impact on chronic pain patients, this review explores the changes in the healthcare delivery system due to social distancing and safety precautions to provide the appropriate management of chronic pain patients during the COVID-19 pandemic. Understanding both the general problems facing chronic pain patients as well as specific problems in the COVID-19 era including deconditioning, increased mental health concerns, financial burdens, and potential for medication-induced immune-suppression is vital in the appropriate management of patients. Telemedicine, the practice of caring for patients remotely when the provider and patient are not physically present with each other, is becoming increasingly used and recognized as a valuable tool to both health care providers and patients. This paper concentrates on the proper utilization of the available resources to help patients with the most severe conditions as well as the most vulnerable group. COVID-19 may be associated with a profound effect on both the health care system and patients with chronic pain. As a result, delaying, or stopping, treatment for chronic pain patients will have negative consequences, and strong pain evaluations must be administered to triage patients appropriately. Recent recommendations for the safe use of non-opioid analgesics, opioid analgesics, and interventional pain management procedures are vital to know and understand specifically during the pandemic era. Further researches are needed to identify the advance planning and rapid responses to reduce the impact of the pandemic.

Background: The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of “elective” interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures. Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic. Objectives: The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques. Methods: The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge. Results: The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included emergent, urgent, and elective procedures. Examples of emergent and urgent procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, urgent procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives. Limitations: COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance. Conclusion: The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus. Key words: Coronavirus, COVID-19, interventional pain management, COVID risk factors, elective surgeries, interventional techniques, chronic pain, immunosuppression

Background: The unexpected COVID-19 crisis has disrupted medical education and patient care in unprecedented ways. Despite the challenges, the health-care system and patients have been both creative and resilient in finding robust “temporary” solutions to these challenges. It is not clear if some of these COVID-era transitional steps will be preserved in the future of medical education and telemedicine. Objectives: The goal of this commentary is to address the sometimes substantial changes in medical education, continuing medical education (CME) activities, residency and fellowship programs, specialty society meetings, and telemedicine, and to consider the value of some of these profound shifts to “business as usual” in the health-care sector. Methods: This is a commentary is based on the limited available literature, online information, and the front-line experiences of the authors. Results: COVID-19 has clearly changed residency and fellowship programs by limiting the amount of hands-on time physicians could spend with patients. Accreditation Council for Graduate Medicine Education has endorsed certain policy changes to promote greater flexibility in programs but still rigorously upholds specific standards. Technological interventions such as telemedicine visits with patients, virtual meetings with colleagues, and online interviews have been introduced, and many trainees are “technoomnivores” who are comfortable using a variety of technology platforms and techniques. Webinars and e-learning are gaining traction now, and their use, practicality, and cost-effectiveness may make them important in the post-COVID era. CME activities have migrated increasingly to virtual events and online programs, a trend that may also continue due to its practicality and cost-effectiveness. While many medical meetings of specialty societies have been postponed or cancelled altogether, technology allows for virtual meetings that may offer versatility and time-saving opportunities for busy clinicians. It may be that future medical meetings embrace a hybrid approach of blending digital with face-toface experience. Telemedicine was already in place prior to the COVID-19 crisis but barriers are rapidly coming down to its widespread use and patients seem to embrace this, even as health-care systems navigate the complicated issues of cybersecurity and patient privacy. Regulatory guidance may be needed to develop safe, secure, and patient-friendly telehealth applications. Telemedicine has affected the prescribing of controlled substances in which online counseling, informed consent, and follow-up must be done in a virtual setting. For example, pill counts can be done in a video call and patients can still get questions answered about their pain therapy, although it is likely that after the crisis, prescribing controlled substances may revert to face-to-face visits. Limitations: The health-care system finds itself in a very fluid situation at the time this was written and changes are still occurring and being assessed. Conclusions: Many of the technological changes imposed so abruptly on the health-care system by the COVID-19 pandemic may be positive and it may be beneficial that some of these transitions be preserved or modified as we move forward. Clinicians must be objective in assessing these changes and retaining those changes that clearly improve health-care education and patient care as we enter the COVID era. Key words: Continuing medical education, COVID-19, fellowship program, medical education, medical meetings, residency program, telehealth, telemedicine

Background: Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain. Objective: To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions. Methods: The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations. Summary of Evidence and Recommendations: Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) . Interventional Diagnosis: Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥ 80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥ 80% pain relief.Limitations: The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy. Conclusions: These facet joint interventions guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations Key words: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis

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's (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's 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's 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.

Opioid use disorder (OUD) is a prevalent condition associated with substantial morbidity, mortality, and healthcare utilization. Prescribers must rely on multiple tools and tactics to help reduce the risk of OUD. These include identification of risk factors for OUD and risk stratification, which must be individualized for each patient. Opioid diversion must be considered distinct from OUD and it has some unique risk factors. Aberrant drug-related behaviours may be observed in those taking opioids and may or may not suggest OUD; risk factors for OUD are dynamic. However, many aberrant drug-related behaviours may be harmless or misinterpreted. A variety of validated risk assessment tools are available to better quantify risk for OUD. An important factor in thwarting OUD remains patient and prescriber education as well as specialized resources such as patient–prescriber agreements, abuse-deterrent formulations of opioids, urine drug screens, and prescription drug monitoring programmes. There is no single, easy way to reduce OUD; instead, prescribers must be aware and make use of the many tools at their disposal to better pre-emptively identify those at elevated risk for OUD and to offer help to those who develop OUD over the course of prescribed opioid therapy.

Introduction: Dental pain is primarily treated by dentists and emergency medicine clinicians and may occur because of insult to the tooth or oral surgery. The dental impaction pain model (DIPM) has been widely used in clinical studies of analgesic agents and is generalizable to many other forms of pain.Areas Covered: The authors discuss the DIPM, which has allowed for important head-to-head studies of analgesic agents, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and combinations. Postsurgical dental pain follows a predictable trajectory over the course of one to 3 days. Dental pain may have odontic origin or may be referred pain from other areas of the body.Expert opinion: Pain following oral surgery has sometimes been treated with longer-than-necessary courses of opioid therapy. Postsurgical dental pain may be moderate to severe but typically resolves in a day or two after the extraction. Opioid monotherapy, rarely used in dentistry but combination therapy (opioid plus acetaminophen or an NSAID), was sometimes used as well as nonopioid analgesic monotherapy. The dental impaction pain model has been valuable in the study of analgesics but does not address all painful conditions, for example, pain with a neuropathic component.

Fear of withdrawal symptoms has been cited by survey respondents as the main reason that they continued to use opioids. Lofexidine is an α2-adrenergic agonist that decreases the sympathetic outflow that results in the characteristic symptoms of opioid withdrawal. A structural analog of clonidine, lofexidine has a higher affinity and specificity for the α2a receptors and does not reinforce opioid dependence. Withdrawal symptoms correlate approximately to the half-life of the opioid; patient factors such as age, duration of opioid exposure, physical status, and other considerations may influence the nature and duration of withdrawal symptoms. For patients with opioid use disorder and psychiatric comorbidities, withdrawal may be destabilizing and may exacerbate mental health status. Lofexidine has been shown in clinical trials to be safe and effective in helping to manage the symptoms of withdrawal and has been recommended in guidelines for this purpose. Adverse events associated with lofexidine include QT prolongation, hypotension, orthostasis, and bradycardia. The maximum course of treatment is 14 days, and doses should be titrated, with the recommended maximum dose to coincide with the most severe withdrawal symptoms (about 5–7 days after opioid discontinuation).

Background: For decades, epidural steroid injections have been an effective tool in the management of many pain related conditions, including lumbar radiculopathy. Transforaminal epidural steroid injections in particular have been reported to potentially result in central nervous system infarctions which have not been reported with interlaminar epidural steroid injections, while providing comparable efficacy. This rare, catastrophic complication has been attributed by some authors to be due to vascular injury secondary to vasospasm, thrombus formation, dissection, as well as concerns with placing the needle at the so-called “safe triangle.” Others, however, have proposed it to be secondary to embolization of the vessel by particulate steroids. This has led to the recommendation of the use of soluble steroids such as dexamethasone when performing TFESI’s, despite concerns over its efficacy and potential for neurotoxicity in the literature. Furthermore, there have also been multiple studies which have revealed that IV dexamethasone is analgesic and that peri-neural dexamethasone is no more effective than IV dexamethasone. Case History: The present case involves a 60-year-old patient with right back and radicular leg pain for 3 years. Two right L4 TFESI’s had been performed with betamethasone several years prior with satisfactory results, until the patient presented to the physician with a pain recurrence of 6 weeks of duration. The patient again underwent a right L4 TFESI with dexamethasone, which provided good relief after 2 weeks. The patient underwent a repeat right L4 TFESI with dexamethasone which was followed by a prompt onset of lower extremity numbness, weakness, and incontinence that was discovered to be related to a conus infarction. While this is the first publicly reported case of a conus medullaris infarction following a lumbar transforaminal injection utilizing dexamethasone, the incidence of these reports may rise as the prevalence of dexamethasone use increases in clinical practice. Conclusion: The spinal cord infarction with TFESI’s may occur related to various mechanisms, regardless of the type of particulate or non-particulate steroid used during these procedures. Key words: Dexamethasone, particulate steroids, non-particulate steroids, conus medullaris infarction, cauda equina syndrome, transforaminal epidural steroid injection, epidural steroid injection, safe triangle, methylprednisolone, paralysis

Introduction There is very strong evidence for the efficacy of transforaminal epidural steroid injection (TFESI) in relieving lumbar radicular pain due to a herniated disk. However, case studies have documented paralysis as a potential complication from this approach as the artery of Adamkiewicz may traverse within the subpedicular “safe triangle.” Kambin's retrodiscal approach has been postulated as a safe means to the transforaminal approach to avoid the artery of Adamkiewicz. Case Presentation A 51-year-old woman presented with right-sided lumbar radicular pain at the L3–L4 and L4–L5 level secondary to a herniated disk. As conservative therapies failed to improve her radicular back pain, the patient opted to proceed with an epidural steroid injection. She subsequently underwent a right L3–L4 and L4–L5 transforaminal epidural steroid injection via Kambin's retrodiscal approach. Although anteroposterior and lateral views revealed optimal needle placement, live and postcontrast fluoroscopy revealed an unavoidable and inadvertent intradiscal spread. Conclusion Kambin's approach is at the level of the intervertebral disk and may increase the incidence of intradiscal needle entry and injection.

Background: Spinal zygapophysial, or facet, joints are a source of axial spinal pain and referred pain in the extremities. Conventional clinical features and other noninvasive diagnostic modalities are unreliable in diagnosing zygapophysial joint pain. Study Design: A systematic review of the diagnostic accuracy of spinal facet joint nerve blocks. Objective: To determine the diagnostic accuracy of spinal facet joint nerve blocks in chronic spinal pain. Methods: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. The level of evidence was classified as Level I to V based on the grading of evidence utilizing best evidence synthesis. Data sources included relevant literature identified through searches of PubMed and other electronic searches published from 1966 through March 2015, Cochrane reviews, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Studies must have been performed utilizing controlled local anesthetic blocks. The criterion standard must have been at least 50% pain relief from baseline scores and the ability to perform previously painful movements. Results: The available evidence is Level I for lumbar facet joint nerve blocks with the inclusion of a total of 17 studies with dual diagnostic blocks, with at least 75% pain relief with an average prevalence of 16% to 41% and false-positive rates of 25% to 44%. The evidence for diagnosis of cervical facet joint pain with cervical facet joint nerve blocks is Level II based on a total of 11 controlled diagnostic accuracy studies, with significant variability among the prevalence in a heterogenous population with internal inconsistency. The prevalence rates ranged from 36% to 67% with at least 80% pain relief as the criterion standard and a false-positive rate of 27% to 63%. The level of evidence for the diagnostic accuracy of thoracic facet joint nerve blocks is Level II with 80% or higher pain relief as the criterion standard with a prevalence ranging from 34% to 48% and false-positive rates ranging from 42% to 48%. Limitations: The shortcomings of this systematic review include a paucity of literature related to the thoracic spine, continued debate on an appropriate gold standard, appropriateness of diagnostic blocks, and utility. Conclusion: The evidence is Level I for the diagnostic accuracy of lumbar facet joint nerve blocks, Level II for cervical facet joint nerve blocks, and Level II for thoracic facet joint nerve blocks in assessment of chronic spinal pain. Key words: Chronic spinal pain, lumbar facet or zygapophysial joint pain, cervical facet or zygapophysial joint pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks

Background: The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate. Objective: To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain. Study Design: A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain. Methods: The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment (IPM – QRB) for randomized trials and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM – QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, 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 were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption. Results: A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement. Limitations: The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections. Conclusion: Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy. Key Words: Spinal pain, chronic low back pain, chronic neck pain, chronic thoracic pain, intraarticular facet joint blocks, facet joint nerve blocks, conventional radiofrequency neurotomy, pulsed radiofrequency neurolysis

OBJECTIVES To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy. METHODS This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study. The proportion of patients who used rescue medication and the amount of rescue medication used on the first (0 to 24 h) and second (>24 to 48 h) days following initial dose of study medication, as well as time to first rescue medication use, were assessed. RESULTS Significantly fewer patients who received SoluMatrix indomethacin 40 or 20 mg 3 times daily used opioid-containing rescue medication on day 1 compared with those receiving placebo (P≤0.034), and fewer patients in all active treatment groups used rescue medication during the second day compared with those in the placebo group (P

ODERN THORACIC SURGERY is used to treat a wide variety of disease states ranging from infectious diseases to malignancies. Thoracotomy and video-assisted thoracoscopic surgery (VATS) can be associated with significant pain, which may negatively impact patient recovery, rehabilitation, and overall satisfaction with medical care as well as potentially lead to chronic postsurgical pain syndromes, underscoring the importance of optimizing pain control. Strategies for acute postoperative pain control and for the treatment of chronic postsurgical pain after thoracic surgery will be discussed.

Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians’ individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine,. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The design of the trial was inappropriate with failure to include existing randomized trials, with inclusion criteria that did not incorporate conservative management,or caudal epidural injections. Simultaneously, acute pain patients were included, multilevel stenosis and various other factors were not identified. The interventions included lumbar interlaminar and transforaminal epidural injections with highly variable volumes of medication being injected per patient. Outcomes assessment was not optimal with assessment of the patients at 3 and 6 weeks for a procedure which provides on average 3 weeks of relief and utilizing an instrument which is more appropriately utilized in acute and subacute low back pain. Analysis of the data was hampered by inadequate subgroup analysis leading to inappropriate interpretation. Based on the available data epidural local anesthetic with steroids was clearly superior at 3 weeks and potentially at 6 weeks. Further, both treatments were effective considering the baseline to 3 week and 6 week assessment, appropriate subgroup analysis seems to have yielded significant superiority for interlaminar epidural injections compared to transforaminal epidural injections with local anesthetic with or without steroids specifically with proportion of patients achieving greater than 50% improvement at 3 and 6 week levels. This critical assessment shows that this study suffers from a challenging design, was premised on the exclusion of available highquality literature, and had inadequate duration of follow-up for an interventional technique with poor assessment criteria and reporting. Finally the analysis and interpretation of data has led to inaccurate and inappropriate conclusions which we do not believe is based on scientific evidence. Key words: Chronic low back pain, central spinal stenosis, epidural injections, local anesthetics, steroids, randomized trials, outcomes assessment

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including “loss of vision, stroke, paralysis, and death.” The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA’s Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence. Key words: Chronic pain, epidural injections, epidural steroids, local anesthetic, radicular artery, complication.

Objective The concept of neuromodulation via the use of spinal cord stimulators (SCS) was first established over forty years ago. Since then, its popularity has grown as numerous studies have demonstrated its utility to reduce chronic pain, improve patient function, and reduce long-term health care costs. The aim of this study was to update the pain medicine community on the evolution of SCS practice trends in academic centers. Design Ninety-three pain medicine fellowship programs in the United States were identified from the Accreditation Council for Graduate Medical Education Website and were contacted to participate in an internet survey. A 37-item questionnaire was inspired by a previous study performed by Fanciullo et al. Questions focused on three main themes regarding SCS clinical application, namely demographics, education, and technical matters. Results Completed surveys were received from 50 institutions, all of which reported performing SCS interventions. Annual implants ranged from 0 to 150. Fellowship training was cited as the most valuable modality for learning implantation. Nearly all programs reported manufacturer representative participation during SCS procedures, with a minority of program directors discouraging their involvement in fellow education. SCS trials were performed exclusively on an outpatient basis. The average length for trials was 4–7 days. The most common indication for SCS implantation was failed back surgery syndrome, which also had the highest 2-year success rate. Post procedure, patients generally were followed up every 2–4 weeks for device reprogramming, which was performed by company representatives 92% of the time. Conclusion Standardized SCS training is imperative as the implementation of neuromodulation therapy continues to increase.

Context: Lumbar post-surgery syndrome is common and often results in chronic, persistent pain and disability, which can lead to multiple interventions. After failure of conservative treatment, either surgical treatment or a nonsurgical modality of treatment such as epidural injections, percutaneous adhesiolysis is often contemplated in managing lumbar post surgery syndrome. Recent guidelines and systematic reviews have reached different conclusions about the level of evidence for the efficacy of epidural injections and percutaneous adhesiolysis in managing lumbar post surgery syndrome. The objective of this systematic review was to determine the efficacy of all 3 percutaneous adhesiolysis anatomical approaches (caudal, interlaminar, and transforaminal) in treating lumbar post-surgery syndrome. Evidence Acquisition: Data Sources: A literature search was performed from 1966 through October 2014 utilizing multiple databases. Study Selection: A systematic review of randomized trials published from 1966 through October 2014 of all types of epidural injections and percutaneous adhesiolysis in managing lumbar post-surgery syndrome was performed including methodological quality assessment utilizing Cochrane review criteria, Interventional Pain Management Techniques–Quality Appraisal of Reliability and Risk of Bias Assessment (IPM–QRB), and grading of evidence using 5 levels of evidence ranging from Level I to Level V. Data Extraction: The search strategy emphasized post-surgery syndrome and related pathologies treated with percutaneous adhesiolysis procedures. Results: The search criteria yielded 16 manuscripts on percutaneous adhesiolysis assessing post-surgery syndrome. Of these, only 4 randomized trials met inclusion criteria for methodological quality assessment, 3 of them were of high quality; and the fourth manuscript was of low quality. Based on these 3 randomized controlled trials, 2 of them with one-day procedure and one with a 3-day procedure, the level of evidence for the efficacy of percutaneous adhesiolysis is Level II based on best evidence synthesis. Conclusions: Based on this systematic review, percutaneous adhesiolysis is effective in managing patients with lumbar post-surgery syndrome after the failure of conservative management including fluoroscopically directed epidural injections.

Background: There is uncertainty in the literature over the relative effectiveness of lumbar epidural interlaminar (IL) steroid injection versus transforaminal (TF) steroid injection for lumbar radiculopathy. Most studies to date have been retrospective, or technically focused. Objective: To complete a randomized, blinded, prospective outcome study of the short-term benefit for IL versus TF epidural steroids for the treatment of subacute lumbar radicular pain. Study design: Prospective, randomized, blinded, subacute efficacy trial. Setting: Tertiary care pain management center, major metropolitan city, United States Methods: After institutional review board approval, 42 age-matched patients with similar lower back pain and unilateral radicular symptoms were enrolled and randomized in a patient and evaluating physician blinded trial to IL or TF epidural steroids from 2007 through 2009. Prior to intervention and 10-16 days after injection, each participant was evaluated by questionnaire and physical exam by an independent physician. All injections were performed by the same physician. Thirty-eight participants completed the study, 18 in the IL group and 20 in the TF group. Four participants required a repeat injection, and 2 participants crossed over to the alternative injection type (IL to TF). Results: Overall, physical exam, diagnostic testing, disability, activity, depression measures, and opioid pill use were similar between the 2 groups, both pre-injection baseline and postinjection improvement. In primary outcomes, the post-injection follow-up Numeric Rating Scale (NRS) was more greatly reduced in the TF group. The NRS decreased from 7.0 ± 1.9 to 3.9 ± 3.1 (mean values +/- standard deviation) in the IL group and 6.4 ± 2.1 to 1.7 ± 1.4 in the TF group. The Oswestry Disability Index was reduced from 37.5 ± 12.6 to 19.0 ± 16.7 in the IL group and 38.3 ± 6.4 to 21.6 ± 16.8 in the TF group. In secondary outcomes, the depression scale was reduced from 4.39 ± 3.22 to 2.28 ± 3.20 in the IL group and 4.10 ± 1.94 to 1.65 ± 1.63 in the TF group. Walking tolerance was increased from 8.1 ± 4.6 blocks to 10.6 ± 4.4 in the IL group and 8.9 ± 5.3 blocks to 11.8 ± 4.2 in the TF group. Limitations: The study did not examine long-term outcomes. A single experienced interventionalist performed all injections. Conclusion: Results suggest that patients may experience greater subjective relief, at least initially, from TF epidural steroid injections over IL. However, more objective, and likely subacute, therapeutic effects are similar. Key words: epidural, steroids, interlaminar, transforaminal, lumbar, lumbosacral, radicular, low back pain

Prescription opioid abuse is a growing problem that has become a critical public health issue. The development of abuse-resistant opioid formulations is an emerging strategy aimed at curbing the abuse of opioid analgesics. Over the next few months to years, new products within this category will enter the market. This article serves to provide an introduction to many of the upcoming formulations that may find their way into the therapeutic arsenal of pain management practitioners.

A majority of patients with acute and chronic pain experience breakthrough pain above their baseline, despite a fixed regimen. The characteristics of current short-acting oral medications are not optimal because they often peak too late and last beyond the duration of pain. Oral absorption limits the onset time, whereas the development of newer routes can shorten onset times. A number of medications, both opioid and nonopioid, are being developed for intranasal delivery with promising results. In addition to the intranasal administration route being efficacious, it also provides better patient satisfaction by allowing the patient to titrate their own pain medication. There are legitimate concerns for abuse and addiction with these medications, which will need to be minimized with proper dispensing modifications. A number of nonopioid agents are also entering the market that will allow for multimechanistic analgesic plans. Although ketamine is not a common component of current pain treatment plans, the development of an intranasal formulation may potentially produce wider acceptance. Many traditional medications, including ibuprofen and acetaminophen, have been developed for parenteral administration. Intravenous ibuprofen or diclofenac can be administered for a longer duration and have a lower bleeding risk then ketorolac. Intravenous acetaminophen can provide balanced analgesia when nonsteroidal anti-inflammatory drugs are contraindicated, as is common in the postoperative period. The role of individual agents in each specialty is not currently clear, but the future treatment of pain, both acute and chronic, is brighter with the addition of these formulations.

Epidural steroid injections (ESIs) are the most commonly performed intervention in the United States to manage chronic and subacute low back and neck pain with radiculopathy. ESIs have been used for decades for the treatment of discogenic and osteoarthritic radicular conditions originating from the cervical, thoracic, and lumbar spine, as well as spondylosis, nonspecific radiculitis, and spinal stenosis. With the ever-increasing use of epidural steroids, there has been a disproportionate increase in popularity of transforaminal ESIs in particular. Since 2002, there has been a growing body of largely transforaminal epidural steroid case report literature that describes paralysis, stroke, and death that immediately follows the performance of these procedures. These complications are thought to be related to a combination of factors, which may include the technique used, underlying pathophysiology that is being treated, anatomical variations in the blood supply, as well as the specific injectate used. This article discusses the pathogenesis of these complications and puts the role of steroids in their causation into perspective.

Background: Epidural injections have been used since 1901 in managing low back pain and sciatica. Spinal pain, disability, health, and economic impact continue to increase, despite numerous modalities of interventions available in managing chronic spinal pain. Thus far, systematic reviews performed to assess the efficacy of epidural injections in managing chronic spinal pain have yielded conflicting results. Objective: To evaluate and update the clinical utility of the efficacy of epidural injections in managing chronic spinal pain. Study Design: A systematic review of randomized controlled trials of epidural injections in managing chronic spinal pain. Methods: In this systematic review, randomized trials with a placebo control or an active-control design were included. The outcome measures were pain relief and functional status improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Best evidence synthesis was conducted based on the qualitative level of evidence (Level I to V). Data sources included relevant literature identified through searches of PubMed for a period starting in 1966 through August 2015; Cochrane reviews; and manual searches of the bibliographies of known primary and review articles. Results: A total of 52 trials met inclusion criteria. Meta-analysis was not feasible. The evidence in managing lumbar disc herniation or radiculitis is Level II for long-term improvement either with caudal, interlaminar, or transforaminal epidural injections with no significant difference among the approaches. The evidence is Level II for long-term management of cervical disc herniation with interlaminar epidural injections. The evidence is Level II to III in managing thoracic disc herniation with an interlaminar approach. The evidence is Level II for caudal and lumbar interlaminar epidural injections with Level III evidence for lumbar transforaminal epidural injections for lumbar spinal stenosis. The evidence is Level II for cervical spinal stenosis management with an interlaminar approach The evidence is Level II for axial or discogenic pain without facet arthropathy or disc herniation treated with caudal or lumbar interlaminar injections in the lumbar region; whereas it is Level II in the cervical region treated with cervical interlaminar epidural injections. The evidence for post lumbar surgery syndrome is Level II with caudal epidural injections and for post cervical surgery syndrome it is Level II with cervical interlaminar epidural injections. Limitations: Even though this is a large systematic review with inclusion of a large number of randomized controlled trials, the paucity of high quality randomized trials literature continues to confound the evidence. Conclusion: This systematic review, with an assessment of the quality of manuscripts and outcome parameters, shows the efficacy of epidural injections in managing a multitude of chronic spinal conditions. Key words: Chronic pain, spinal pain, epidural injections, local anesthetic, steroids, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections

Cancer pain is prevalent, undertreated, and feared by patients with cancer. In April 2013, a panel of pain experts convened in Singapore to address the treatment of cancer pain. They discussed the various types of cancer pain, including breakthrough pain, which is sometimes clinically confused with analgesic gaps. Reasons for undertreating cancer pain include attitudes of patients, clinicians, and factors associated with healthcare systems. The consequences of not treating cancer pain may include reduced quality of life for patients with cancer (who now live longer than ever), functional decline, and increased psychological stress. Early analgesic intervention for cancer pain may reduce the risk of central sensitization and chronification of pain. To manage pain in oncology patients, clinicians should assess pain during regular follow-up visits using validated pain measurement tools and follow prescribing guidelines, if necessary referring patients with cancer to pain specialists. Many patients with cancer require opioids for pain relief. Pain associated with cancer may also relate to cancer treatments, such as chemotherapy-induced peripheral neuropathy. Many patients with cancer are what might be considered "special populations," in that they may be elderly, frail, comorbid, or have end-stage organ failure. Specific pain therapy guidelines for those populations are reviewed. Patients with cancer with a history of or active substance abuse disorder deserve pain control but may require close medical supervision. While much "treatment inertia" exists in cancer pain control, cancer pain can be safely and effectively managed and should be carried out to alleviate suffering and improve outcomes.

Phantom limb pain has been well described in the literature. However, new-onset lumbar radicular pain superimposed on baseline lower extremity phantom pain is a clinical scenario that can be challenging to recognize. Furthermore, literature on recognition and treatment of phantom radiculopathy is all but lacking. We present a patient who experienced new-onset lumbar radiculopathy superimposed on her phantom pain that was successfully treated with fluoroscopic interlaminar and transforaminal epidural steroid injections.

Objective Identify the risk factors for prescription opioid misuse among patients taking prescription opioids to deal with chronic pain. Methods We examined the literature for a variety of dynamic risk factors associated with opioid misuse among the chronic pain population in order to present a narrative review. Considered were: taking single or multiple opioids, pain intensity, mental health disorders, including a history of preadolescent sexual abuse, personal and familial history of substance abuse, a history of legal problems, being a crime victim, drug-seeking behaviors, drug craving, and age. Results A variety of risk factors have been studied in the literature. Risk factors in chronic opioid therapy patients are dynamic in that they can change with disease progression, tolerance, changes in pain quality, mental health, comorbidities, other drug therapies or drug interactions, and changes in the patient's lifestyle. Conclusion Opioid analgesic therapy must be tailored to carefully monitor all patients in order to minimize misuse and abuse, since the risk is constant and dynamic and therefore every patient is at some degree of risk for opioid misuse.

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 long-term follow-ups. 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 high-quality 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.

EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, indicated for the management of chronic moderate to severe pain, contain extended-release pellets of morphine sulfate with a sequestered core of naltrexone, an opioid antagonist. When EMBEDA is taken orally as directed, it is bioequivalent with regard to rate and extent of plasma morphine absorption to KADIAN® (morphine sulfate extended-release) Capsules, a similar formulation without naltrexone. EMBEDA has been shown to be significantly superior to placebo in maintaining pain relief over 12 weeks and, in one of the longest durability studies, to reduce pain intensity for up to 12 months. Upon tampering by crushing EMBEDA, naltrexone is released to mitigate morphine-induced euphoria. Euphoria and drug-liking measures after oral administration of intact or crushed EMBEDA were similar, and were reduced compared with morphine sulfate solution; crushing EMBEDA did not yield more euphoria and desirability for abuse than the intact product. The most common adverse events after long-term use were constipation, nausea, and vomiting, which are typical of opioids. Over long-term use as directed, there was no evidence of naltrexone accumulation or opioid withdrawal. The impact of formulations such as EMBEDA on the abuse rate among real-world abusers requires long-term epidemiologic studies.