Updated Assessment of Practice Patterns of Perioperative Management of Antiplatelet and Anticoagulant Therapy in Interventional Pain Management.

BACKGROUND: The role of antiplatelet/anticoagulant therapy is well known for its primary and secondary prevention of sequela from cardiovascular disease by decreasing the incidence of acute cerebral, cardiovascular, peripheral vascular, and other thrombo-embolicevents. The overwhelming data show that the risk of thrombotic events is significantly higher than that of bleeding during surgery after antiplatelet drug discontinuation. It has been assumed that discontinuing antiplatelet therapy prior to performing interventional pain management techniques is a common practice, even though doing so may potentially increase the risk of acute cerebral and cardiovascular events. A survey of practice patterns was conducted in 2012, since then the risks associated with thromboembolic events and bleeding, has not been systematically evaluated. OBJECTIVE: To conduct an updated assessment of the perioperative antiplatelet and anticoagulant practice patterns of U.S. interventional pain management physicians and compare this with data collected in 2012 with 2021 data regarding practice patterns of continuing or discontinuing anticoagulant therapy. STUDY DESIGNn: Postal survey of interventional pain management physicians. STUDY SETTING: Interventional pain management practices in the United States. METHODS: The survey was conducted based on online responses of the members of the American Society of Interventional Pain Physicians (ASIPP) in 2021. The survey was designed similar to the 2012 survey to assess updated practice patterns. RESULTS: The questionnaire was sent out to 1,700 members in October 2021. Out of these, 185 members completed the survey, while 105 were returned due to invalid addresses. The results showed that 23% changed their practice patterns during the previous year. The results also showed that all physicians discontinued warfarin therapy with the majority of physicians accepting an INR of 1.5 as a safe level. Low dose aspirin (81 mg) was discontinued for 3 to 7 days for low-risk procedures by 8% of the physicians, 34% of the physicians for moderate or intermediate risk procedures, whereas they were discontinued by 76% of the physicians for high-risk procedures. High dose aspirin (325 mg) was discontinued at a higher rate. Antiplatelet agents, including dipyridamole, cilostazol, and Aggrenox (aspirin, extended-release dipyridamole) were discontinued from 3 to 5 days by 18%-23% of the physicians for low-risk procedures, approximately 60% of the physicians for moderate or intermediate-risk procedures, and over 90% of the physicians for high-risk procedures. Platelet aggregation inhibitors clopidogrel, prasugrel, ticlopidine, and ticagrelor were discontinued for 3 to 5 days by approximately 26% to 41% for low-risk procedures, almost 90% for moderate or intermediate-risk procedures, and over 97% for high-risk procedures. Thrombin inhibitor dabigatran was discontinued by 33% of the physicians for low-risk procedures, 92% for moderate or intermediate-risk procedures, and 99% for high-risk procedures. Anti-Xa agents, apixaban, rivaroxaban, and Edoxaban were discontinued in over 25% of the physicians for low-risk procedures, approximately 90% for moderate or intermediate-risk procedures, and 99% for high-risk procedures. LIMITATIONS: This study was limited by its being an online survey of the membership of one organization in one country, that there was only a 11.6% response rate, and the sample size is relatively small. Underreporting in surveys is common. Further, the incidence of thromboembolic events or epidural hematomas was not assessed. CONCLUSION: The results in the 2021 survey illustrate a continued pattern of discontinuing antiplatelet and anticoagulant therapy in the perioperative period. The majority of discontinuation patterns appear to fall within guidelines.

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

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.

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

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

Efficacy of Percutaneous Adhesiolysis in Managing Low Back and Lower Extremity Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

INTRODUCTION: Chronic refractory low back and lower extremity pain recalcitrant to conservative management and epidural injections secondary to postsurgery syndrome, spinal stenosis, and disc herniation are sometimes managed with percutaneous adhesiolysis. Consequently, this systematic review and meta-analysis was undertaken to assess the efficacy of percutaneous adhesiolysis in managing low back and lower extremity pain. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases from 1966 to July 2022, including manual searches of the bibliography of known review articles was performed. Quality assessment of the included trials, meta-analysis, and best evidence synthesis was performed. The primary outcome measure was a significant reduction in pain (short term up to 6 months and long term more than 6 months). RESULTS: The search identified 26 publications, with 9 trials meeting the inclusion criteria. The results of dual-arm and single-arm analyses showed significant improvement in pain and function at 12 months. Opioid consumption was also significantly reduced at 6 months with dual-arm analysis, whereas single-arm analysis showed a significant decrease from baseline to treatment at the 3-, 6-, and 12-month analyses. At 1 year follow-up, seven of seven trials were positive for improvements in pain relief, function, and diminution of opioid use. DISCUSSION: Based on the present systematic review of nine RCTs, the evidence level is I to II, with moderate to strong recommendation for percutaneous adhesiolysis in managing low back and lower extremity pain. The limitations of the evidence include paucity of literature, lack of placebo-controlled trials, and the majority of the trials studying post lumbar surgery syndrome. CONCLUSION: The evidence is level I to II or strong to moderate based on five high-quality and two moderate-quality RCTs, with 1 year follow-up that percutaneous adhesiolysis is efficacious in the treatment of chronic refractory low back and lower extremity pain.

The Impact of COVID-19 on Interventional Pain Management Practices is Significant and Long-Lasting: An Interventional Pain Management Physician Survey.

BACKGROUND: As with many others in the house of medicine, the COVID-19 pandemic has adversely impacted the practice of interventional pain management. This in part relates to various  state health authority or medical board restrictions with reductions in patient volume for evaluations, follow-ups, and procedures. Of course, the pandemic continues to persist which is in turn leading to longer-lasting effects. Our previous survey was performed in March 2020. At that time, there was a national lockdown in the United States with COVID-19 disease qualifying as a pandemic by the World Health Organization (WHO). The pandemic caused by COVID-19 disease continues to have far-reaching implications on how we deliver routine care to patients and its effect on patient care, economic aspects, and health of interventional pain management providers. OBJECTIVE: To assess the current and expected future impact of the COVID-19 pandemic on interventional pain management practices in a physician survey. The study was performed based on performance in 2021 compared to the 2019 pre-COVID era. METHODS: The American Society of Interventional Pain Physicians (ASIPP) administered a 16-question survey to their members by contacting them via a commercially available online marketing company platform. The survey was completed on www.constantcontact.com. RESULTS: The results showed that 88% of the providers experienced a reduction in income and a similar number expect decreases over the next 12 months. A large proportion of respondents (73.3%) reported a reduction in revenue of 11%-25%. In contrast, another 21.5% reported a revenue decline of 26%-50%, and 29% reported 11%-25% increase in expenses. Overall, new patient volume decreased 11%-25% based on the response from almost 63%, whereas almost 9% reported a decline of 26%-50%. In contrast, established patient volume declined 1%-10% as reported by 64% of the respondents, compared to an 11%-25% decrease by a small proportion of 14%. All interventional procedures showed significant decreases across the board, with 69% of the respondents reporting a decline in-office procedures, 64% in ambulatory surgery center (ASC) procedures, and 57% in hospital outpatient department (HOPD) procedures, ranging from 11%-25%. LIMITATIONS: The survey included a relatively small number of member physicians which could introduce sampling error. Consequently, it may not be generalizable for other specialties or even to pain medicine. CONCLUSION: The COVID-19 pandemic has put interventional pain practices throughout the United States under considerable financial and psychological stress. This study seeks to quantify the extent of economic loss and other challenges resultant from the pandemic. Almost 99% reported a decrease in revenues in the last 12 months, with 86% reporting an expected reduction in the next 12 months and 49% reporting an increase in expenses. Declines have been reported in all sectors with new patients, office procedures, ASC, and HOPD procedures, except for established patient visits, which have shown minor declines compared to other domains. Understanding the issues facing interventional pain management physicians facilitates the development of strategies to actively manage provider practice/well-being, and to minimize risk to personnel to keep patients safe.

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

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

Triaging Interventional Pain Procedures During COVID-19 or Related Elective Surgery Restrictions: Evidence-Informed Guidance from the American Society of Interventional Pain Physicians (ASIPP).

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 urgent, emergency, and elective procedures. Examples of urgent and emergency 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, emergency 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.

Lack of Superiority of Epidural Injections with Lidocaine with Steroids Compared to Without Steroids in Spinal Pain: A Systematic Review and Meta-Analysis.

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.

Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines.

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.Cervical Spine: • The level of evidence is II with moderate strength of recommendation. • Ten relevant diagnostic accuracy studies, 9 of the 10 studies with either controlled comparative local anesthetic blocks or placebo controls with concordant pain relief with a criterion standard of ≥80% were included. • The prevalence and false-positive rates ranged from 29% to 60% and of 27% to 63%, with high variability. Thoracic Spine: • The level of evidence is II with moderate strength of recommendation. • Three relevant diagnostic accuracy studies, with controlled comparative local anesthetic blocks, with concordant pain relief, with a criterion standard of ≥80% were included. • The prevalence varied from 34% to 48%, whereas false-positive rates varied from 42% to 58%.Therapeutic Facet Joint Interventions: Lumbar Spine: • The level of evidence is II with moderate strength of recommendation for lumbar radiofrequency ablation with inclusion of 11 relevant randomized controlled trials (RCTs) with 2 negative studies and 4 studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic lumbar facet joint nerve blocks with inclusion of 3 relevant randomized controlled trials, with long-term improvement. • The level of evidence is IV with weak strength of recommendation for lumbar facet joint intraarticular injections with inclusion of 9 relevant randomized controlled trials, with majority of them showing lack of effectiveness without the use of local anesthetic. Cervical Spine: • The level of evidence is II with moderate strength of recommendation for cervical radiofrequency ablation with inclusion of one randomized controlled trial with positive results and 2 observational studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic cervical facet joint nerve blocks with inclusion of one relevant randomized controlled trial and 3 observational studies, with long-term improvement. • The level of evidence is V with weak strength of recommendation for cervical intraarticular facet joint injections with inclusion of 3 relevant randomized controlled trials, with 2 observational studies, the majority showing lack of effectiveness, whereas one study with 6-month follow-up, showed lack of long-term improvement. Thoracic Spine: • The level of evidence is III with weak to moderate strength of recommendation with emerging evidence for thoracic radiofrequency ablation with inclusion of one relevant randomized controlled trial and 3 observational studies. • The level of evidence is II with moderate strength of recommendation for thoracic therapeutic facet joint nerve blocks with inclusion of 2 randomized controlled trials and one observational study with long-term improvement. • The level of evidence is III with weak to moderate strength of recommendation for thoracic intraarticular facet joint injections with inclusion of one randomized controlled trial with 6 month follow-up, with emerging evidence. Antithrombotic Therapy: • Facet joint interventions are considered as moderate to low risk procedures; consequently, antithrombotic therapy may be continued based on overall general status. Sedation: • The level of evidence is II with moderate strength of recommendation to avoid opioid analgesics during the diagnosis with interventional techniques. • The level of evidence is II with moderate strength of recommendation that moderate sedation may be utilized for patient comfort and to control anxiety for therapeutic facet joint interventions. 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 intervention 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.

Is Percutaneous Adhesiolysis Effective in Managing Chronic Low Back and Lower Extremity Pain in Post-surgery Syndrome: a Systematic Review and Meta-analysis.

PURPOSE OF REVIEW: The growing prevalence of spinal pain in the USA continues to produce substantial economic impact and strain on health-related quality of life. Percutaneous adhesiolysis is utilized for recalcitrant, resistant conditions involving spinal pain when epidural injections have failed to provide adequate improvement, especially low back and lower extremity pain, specifically in post-lumbar surgery syndrome. Despite multiple publications and systematic reviews, the debate continues in reference to effectiveness, safety, appropriate utilization, and medical necessity of percutaneous adhesiolysis in chronic pain. This systematic review, therefore, was undertaken to evaluate and to update effectiveness of percutaneous adhesiolysis to treat chronic refractory low back and lower extremity pain, post-surgical patients of the lumbar spine. RECENT FINDINGS: From 2009 to 2016, there was a decline of 53.2% utilization of percutaneous adhesiolysis with an annual decline of 10.3% per 100,000 fee-for-service (FFS) Medicare population. Multiple insurers, including Medicare, with Medicare area contractors of Noridian and Palmetto have issued noncoverage policies for percutaneous adhesiolysis resulting in these steep declines and continued noncoverage by Medicare Advantage plans, Managed Care plans of Medicaid, and other insurers. Since 2005, 4 systematic reviews of percutaneous adhesiolysis were published with 3 of them showing proper methodology and appropriate results with effectiveness of adhesiolysis, whereas one poorly performed systematic review showed negative results. In addition, there were only 4 randomized controlled trials (RCTs) to be included in the previous systematic reviews of post-surgery syndrome, whereas now, the RCTs and other studies have increased. This systematic review shows level I or strong evidence for the effectiveness of percutaneous adhesiolysis in managing chronic low back and lower extremity pain related to post-lumbar surgery syndrome.

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

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.

Evaluation of Cost-Utility of Thoracic Interlaminar Epidural Injections.

PURPOSE OF REVIEW: Chronic thoracic pain, even though not as prevalent as low back and neck pain, appears in approximately 30% of the general population. The severity of thoracic pain and degree of disability seems to be similar to other painful conditions. Despite this severity, interventions in managing chronic thoracic pain are less frequent, and there is a paucity of literature regarding epidural injections and facet joint interventions. RECENT FINDINGS: As with lumbar and cervical spine, a multitude of interventions are offered in managing chronic thoracic pain, including interventional techniques with epidural injections and facet joint interventions. A single randomized controlled trial (RCT) has been published with a 2-year follow-up of clinical effectiveness of the results. However, there have not been any cost-utility analysis studies pertaining to either epidural injections or facet joint interventions in thoracic pain. Based on the results of the RCT, a cost-utility analysis of thoracic interlaminar epidural injections was undertaken. Evaluation of the cost-utility analysis of thoracic interlaminar epidural injections with or without steroids in managing thoracic disc herniation, thoracic spinal stenosis, and thoracic discogenic or axial pain was assessed in 110 patients with a 2-year follow-up. Direct payment data from 2018 was utilized for procedural costs and indirect costs. Costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 or addition of 40% of cost to accommodate for indirect payments and arrive at overall costs. Cost-utility analysis showed direct procedural cost of USD $1943.19, whereas total estimated costs year per QALY were USD $3245.12.

Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Central Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis.

BACKGROUND: Symptomatic lumbar spinal stenosis is a condition affecting a growing number of individuals resulting in significant disability and pain, leading to a multitude of interventions ranging from simple over the counter medication to opioids, and, finally, to complex surgical fusions. After failure of conservative treatment with drug therapy, physical therapy, and other conservative modalities including epidural injections, percutaneous adhesiolysis with targeted delivery of drugs into the epidural space can be offered in lumbar central spinal stenosis prior to minimally invasive surgical options or complex surgical fusions. To date there has been only one systematic review which has assessed the role of percutaneous adhesiolysis in treating central spinal stenosis, compared to post lumbar surgery syndrome which has multiple systematic reviews and randomized controlled trials (RCTs). STUDY DESIGN: A systematic review of RCTs and observational studies assessing the role of percutaneous adhesiolysis in managing lumbar central spinal stenosis. OBJECTIVE: To evaluate the effectiveness of percutaneous adhesiolysis in managing central lumbar spinal stenosis, utilizing currently available literature. METHODS: This systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for literature search, Cochrane review criteria, Interventional Pain Management techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB), and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) to assess methodologic quality assessment and qualitative analysis utilizing best evidence synthesis principles, and 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 June 2019. The evidence was summarized utilizing principles of the best evidence synthesis on a scale of 1 to 5. OUTCOME MEASURES: The primary outcome or hard endpoint was defined as the proportion of patients with 50% pain relief and improvement in functionality, whereas the secondary outcome measures or soft endpoints were pain relief and/or improvement in functionality. Short-term effectiveness was defined as improvement of 6 months or less, whereas long-term effectiveness was defined as more than 6 months. RESULTS: Based on search criteria, 9 manuscripts were identified and considered for inclusion with final inclusion of 2 RCTs and 4 observational studies in this systematic review and 5 studies for single arm meta-analysis. The results showed Level II evidence for short-term and long-term improvement in pain and function with application of percutaneous adhesiolysis in managing central lumbar spinal stenosis. LIMITATIONS: There was a significant paucity of evidence assessing the role of percutaneous adhesiolysis in managing lumbar central spinal stenosis, leading to Level II or strong evidence. CONCLUSION: Overall, the present analysis shows Level II (moderate) evidence for percutaneous adhesiolysis in managing lumbar central spinal stenosis based on relevant high quality RCTs and observational studies. KEY WORDS: Lumbar central spinal stenosis, percutaneous adhesiolysis, randomized controlled trials, systematic reviews, neuroplasty.

Cervical Interlaminar Epidural Injections in the Treatment of Cervical Disc Herniation, Post Surgery Syndrome, or Discogenic Pain: Cost Utility Analysis from Randomized Trials.

BACKGROUND: Neck pain is one of the major conditions attributing to overall disability in the United States. There have been multiple publications assessing clinical and cost effectiveness of multiple modalities of interventions in managing chronic neck pain. Even then, the literature has been considered sparse in relation to cervical interlaminar epidural injections in managing chronic neck pain. In contrast, cost utility studies of lumbar interlaminar injections, caudal epidural injections, cervical and lumbar facet joint nerve blocks, percutaneous adhesiolysis demonstrated costs of less than $3,500 for quality-adjusted life year (QALY). OBJECTIVES: To assess the cost utility of cervical interlaminar epidural injections in managing chronic neck and/or upper extremity pain secondary to cervical disc herniation, post-surgery syndrome in neck, and axial or discogenic neck pain. STUDY DESIGN: Analysis based on 3 previously published randomized trials of the effectiveness of cervical interlaminar epidural injections assessing their role in disc herniation, cervical post-surgery syndrome, and axial or discogenic pain. SETTING: A contemporary, private, specialty referral interventional pain management center in the United States. METHODS: Cost utility of cervical interlaminar epidural injections with or without steroids in managing cervical disc herniation, cervical post-surgery syndrome, and cervical discogenic or axial neck back pain was conducted with data derived from 3 randomized controlled trials (RCTs) that included a 2-year follow-up, with inclusion of 356 patients. The primary outcome was significant improvement defined as at least 50% in pain reduction and disability status. Direct payment data from all carriers from 2018 was utilized for the assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.67 to accommodate for indirect payments respectively for disc herniation, discogenic pain, and cervical post-surgery syndrome. RESULTS: The results of the 3 RCTs showed direct cost utility for one year of QALY of $2,412.31 for axial or discogenic pain without disc herniation, $2,081.07 for disc herniation, and $2,309.20 for post surgery syndrome, with an average cost per one year QALY of $2,267.57, with total estimated overall costs with addition of indirect costs of $3,475.38, $4,028.55, $3,856.36, and $3,785.89 respectively. LIMITATIONS: The limitation of this cost utility analysis includes that it is a single center evaluation. Indirect costs were extrapolated. CONCLUSION: This cost utility analysis of cervical interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, post surgery syndrome and axial or discogenic neck pain shows $2,267.57 for direct costs with a total cost of $3,785.89 per QALY. KEY WORDS: Cervical interlaminar epidural injections, chronic neck pain, cervical disc herniation, cervical discogenic pain, post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years.