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 trends of the expenditures of facet joint interventions have not been specifically assessed in the fee-for-service (FFS) Medicare population since 2009 Objectives: The objective of this investigation is to assess trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009 to 2018. Study Design: The study was designed to analyze trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009-2018 in the United States. In this manuscript: • A patient was considered as undergoing facet joint interventions throughout the year. • A visit included all regions treated during the visit. • An episode was considered as one per region utilizing primary codes only. • Services or procedures were considered all procedures (multiple levels). Data for the analysis was obtained from the standard 5% national sample of the Centers for Medicare & Medicaid Services (CMS) physician outpatient billing claims for those enrolled in the FFS Medicare program from 2009 to 2018. All the expenditures were presented with allowed costs and also were inflation adjusted to 2018 US dollars. Results: This analysis showed expenditures increased by 79% from 2009 to 2018 in the form of total cost for facet joint interventions, at an annual rate of 6.7%. Cervical and lumbar radiofrequency neurotomy procedures increased 185% and 169%. However, inflation-adjusted expenditures with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. In addition, using inflation-adjusted expenditures per procedures increased, the overall 6% with an annual increase of 0.7%. Overall, per patient costs, with inflation adjustment, decreased from $1,925 to $1,785 with a decline of 7% and an annual decline of 0.8%. Allowed charges per visit also declined after inflation adjustment from $951.76 to $849.86 with an overall decline of 11% and an annual decline of 1.3%. Staged episodes of radiofrequency neurotomy were performed in 23.9% of patients and more than 2 episodes for radiofrequency neurotomy in 6.9%, in lumbar spine and 19.6% staged and 5.1% more than 2 episodes in cervical spine of patients in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. Conclusions: Even after adjusting for inflation, there was a significant increase for the expenditures of facet joint interventions with an overall 53% increase. Costs per patient and cost per visit declined. Inflation-adjusted cost per year declined 7% overall and 0.8% annually from $1,925 to $1,785, and inflation-adjusted cost per visit also declined 11% annually and 1.3% per year from $952 in 2009 to $850 in 2018. Key words: Facet joint interventions, facet joint nerve blocks, facet joint neurolysis, facet joint injections, Medicare expenditures

Background: Spinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes. Objective:The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP).Methods: This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12-month follow-up.Results: One hundred twenty-eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3-month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups. Conclusion:Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were M ET HOD S Study design and patient selectionThis multicenter, prospective, open-label, postmarket RCT was designed to assess DTM SCS as compared with traditional SCS in subjects with intractable LBP and LP. The study was conducted at 12 investigational sites across the United States in compliance with the US Code of Federal Regulations, Good Clinical Practice Guidelines, and the 18th World Medical Assembly of Helsinki. The study protocol and informed consent forms were approved by the Western Institutional Review Board, Puyallup, WA. The study was registered with clinicaltrials.gov (NCT03606187). Key eligibility criteria are listed in Table 1.sustained over 12 months and are expected to significantly impact the management of chronic LBP.

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: Interventional techniques for managing spinal pain, from conservative modalities to surgical interventions, are thought to have been growing rapidly. Interventional techniques take center stage in managing chronic spinal pain. Specifically, facet joint interventions experienced explosive growth rates from 2000 to 2009, with a reversal of these growth patterns and in some settings, a trend of decline after 2009. Objectives: The objectives of this assessment of utilization patterns include providing an update of facet joint interventions in managing chronic spinal pain in the fee-for-service (FFS) Medicare population of the United States from 2000 to 2018. Study Design: The study was designed to assess utilization patterns and variables of facet joint interventions in managing chronic spinal pain from 2000 to 2018 in the FFS Medicare population in the United States. Methods: Data for the analysis were obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. Results: Facet joint interventions increased 1.9% annually and 18.8% total from 2009 to 2018 per 100,000 FFS Medicare population compared with an annual increase of 17% and overall increase of 309.9% from 2000 to 2009. Lumbosacral facet joint nerve block sessions or visits decreased at an annual rate of 0.2% from 2009 to 2018, with an increase of 15.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis sessions increased at an annual rate of 7.4% from 2009 to 2018, and the utilization rate also increased at an annual rate of 23.0% from 2000 to 2009. The proportion of lumbar facet joint blocks sessions to lumbosacral facet joint neurolysis sessions changed from 6.7 in 2000 to 1.9 in 2018. Cervical and thoracic facet joint injections increased at an annual rate of 0.5% compared with cervicothoracic facet neurolysis sessions of 8.7% from 2009 to 2018. Cervical facet joint injections increased to 4.9% from 2009 to 2018 compared with neurolysis procedures of 112%. The proportion of cervical facet joint injection sessions to neurolysis sessions changed from 8.9 in 2000 to 2.4 in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. The utilization data for individual states also continues to be sparse and may not be accurate. Conclusions: Utilization patterns of facet joint interventions increased 1.9% per 100,000 Medicare population from 2009 to 2018. This results from an annual decline of - 0.2% lumbar facet joint injection sessions but with an increase of facet joint radiofrequency sessions of 7.4%. Key words: Interventional techniques, facet joint interventions, facet joint nerve blocks, facet joint neurolysis

Background: With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures. Objectives: The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-forservice (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018. Study Design: Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States. Methods: This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results: Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals. Limitations: This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population. Conclusions: The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections. Key words: Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns

Background: The cost of US health care continues to increase, with treatments related to low back and neck pain and other musculoskeletal disorders accounting for the third highest amount of various disease categories. Interventional techniques for managing pain apart from conservative modalities and surgical interventions, have generally been thought to be growing rapidly. However, a recent analysis of utilization of interventional techniques from 2000 to 2016 has shown a modest decline from 2009 to 2016, compared to 2000 to 2009. Objectives: The objectives of this analysis include providing an update on utilization of interventional techniques in managing chronic pain in the Medicare population from 2009 to 2018 in the fee-for-service (FFS) Medicare population of the United States. Study Design: Utilization patterns and variables of interventional techniques in managing chronic pain were assessed from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population of the United States. Methods: The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. Results: The analysis of data showed that there was a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 FFS Medicare population, despite an increase of 0.7% per year of population growth (3.2% of those 65 years or older) and a 3% annual increase in Medicare participation from 2009 to 2018. Medicare data from 2000 to 2009 showed an increase of 11.8% per year per 100,000 individuals of the Medicare population. The 2009 to 2018 data also showed a 2.6% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 population of FFS Medicare, and a 1% decrease for disc procedures and other types of nerve blocks, while there was an increase of 0.9% annually for facet joint interventions and sacroiliac joint blocks. Limitations: Limitations of this analysis include: only the Medicare population was utilized, and among the Medicare population, only the FFS population was evaluated; utilization patterns in Medicare Advantage Plans, which constitutes almost 30% of the population were not considered. Further, the utilization data for individual states was sparse and may not be accurate. Conclusion: The decline in utilization of interventional techniques continued from 2009 to 2018 with 6.7% per 100,000 Medicare population, with an annual decline of 0.8%, despite an increase in the population rate and Medicare enrollees of 0.7% and 3% annually. Key words: Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks

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