Publications by authors named "Mark V Boswell"

99 Publications

COVID-19 Pandemic Reduced Utilization Of Interventional Techniques 18.7% In Managing Chronic Pain In The Medicare Population In 2020: Analysis Of Utilization Data From 2000 To 2020.

Pain Physician 2022 05;25(3):223-238

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: Multiple publications have shown the significant impact of the COVID-19 pandemic on US healthcare and increasing costs over the recent years in managing low back and neck pain as well as other musculoskeletal disorders. The COVID-19 pandemic has affected many modalities of treatments, including those related to chronic pain management, including both interventional techniques and opioids. While there have not been assessments of utilization of interventional techniques specific to the ongoing COVID-19 pandemic, previous analysis published with data from 2000 to 2018 demonstrated a decline in utilization of interventional techniques from 2009 to 2018 of 6.7%, with an annual decline of 0.8% per 100,000 fee-for-service (FFS) in the Medicare population. During that same time, the Medicare population has grown by 3% annually.

Objectives: The objectives of this analysis include an evaluation of the impact of the COVID-19 pandemic, as well as an updated assessment of the utilization of interventional techniques in managing chronic pain in the Medicare population from 2010 to 2019, 2010 to 2020, and 2019 to 2020 in the FFS Medicare population of the United States.

Study Design: Utilization patterns and variables of interventional techniques with the impact of the COVID-19 pandemic in managing chronic pain were assessed from 2000 to 2020 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 2020.

Results: The results of the present investigation revealed an 18.7% decrease in utilization of all interventional techniques per 100,000 Medicare beneficiaries from 2019 to 2020, with a 19% decrease for epidural and adhesiolysis procedures, a 17.5% decrease for facet joint interventions and sacroiliac joint blocks, and a 25.4% decrease for disc procedures and other types of nerve blocks. The results differed from 2000 to 2010 with an annualized increase of 10.2% per 100,000 Medicare population compared to an annualized decrease of 0.4% from 2010 to 2019, and a 2.5% decrease from 2010 to 2020 for all interventional techniques. For epidural and adhesiolysis procedures decreases were more significant and annualized at 3.1% from 2010 to 2019, increasing the decline to 4.8% from 2010 to 2020. For facet joint interventions and sacroiliac joint blocks, the reversal of growth patterns was observed but maintained at an annualized rate increase of 2.1% from 2010 to 2019, which changed to a decrease of 0.01% from 2010 to 2020. Disc procedures and other types of nerve blocks showed similar patterns as epidurals with an 0.8% annualized reduction from 2010 to 2019, which was further reduced to 3.6% from 2010 to 2020 due to COVID-19.

Limitations: Data for the COVID-19 pandemic impact were available only for 2019 and 2020 and only the FFS Medicare population was utilized; utilization patterns in Medicare Advantage Plans, which constitutes almost 40% of the Medicare enrollment in 2020 were not available. Moreover, this analysis shares the limitations present in all retrospective reviews of claims based datasets.

Conclusion: The decline driven by the COVID-19 pandemic was 18.7% from 2019 to 2020. Overall decline in utilization in interventional techniques from 2010 to 2020 was 22.0% per 100,000 Medicare population, with an annual diminution of 2.5%, despite an increase in the population rate of 3.3% annualized (38.9% overall) and Medicare enrollees of 33.4% and 2.9% annually.
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May 2022

Fourth Wave of Opioid (Illicit Drug) Overdose Deaths and Diminishing Access to Prescription Opioids and Interventional Techniques: Cause and Effect.

Pain Physician 2022 03;25(2):97-124

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: In the midst of the COVID-19 pandemic, data has shown that age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, and heroin have been increasing, including prescription opioid deaths, which were declining, but, recently, reversing the trends. Contrary to widely held perceptions, the problem of misuse, abuse, and diversion of prescription opioids has been the least of all the factors in recent years. Consequently, it is important to properly distinguish between the role of illicit and prescription opioids in the current opioid crisis. Multiple efforts have been based on consensus on administrative policies for certain harm reduction strategies for individuals actively using illicit drugs and reducing opioid prescriptions leading to curbing of medically needed opioids, which have been ineffective. While there is no denial that prescription opioids can be misused, abused, and diverted, the policies have oversimplified the issue by curbing prescription opioids and the pendulum has swung too far in the direction of severely limiting prescription opioids, without acknowledgement that opioids have legitimate uses for persons suffering from chronic pain. Similar to the opioid crisis, interventional pain management procedures have been affected by various policies being applied to reduce overuse, abuse, and finally utilization. Medical policies have been becoming more restrictive with reduction of access to certain procedures, with the pendulum swinging too far in the direction of limiting interventional techniques. Recent utilization assessments have shown a consistent decline for most interventional techniques, with a 18.7% decrease from 2019 to 2020. The causes for these dynamic changes are multifactorial likely including the misapplication of the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain, the relative ease of access to illicit synthetic opioids and more recently issues related to the COVID-19 pandemic. In addition, recent publications have shown association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. These findings are leading to the hypothesis that federal guidelines may inadvertently be contributing to an increase in overall opioid deaths and diminished access to interventional techniques. Together, these have resulted in a fourth wave of the opioid epidemic.

Methods: A narrative review.

Results: The fourth wave results from a confluence of multiple factors, including misapplication of CDC guidelines, the increased availability of illicit drugs, the COVID-19 pandemic, and policies reducing access to interventional procedures. The CDC guidelines and subsequent regulatory atmosphere have led to aggressive tapering up to and including, at times, the overall reduction or stoppage of opioid prescriptions. Forced tapering has been linked to an increase of 69% for overdoses and 130% for mental health crisis. The data thus suggests that the diminution in access to opioid prescriptions may be occurring simultaneously with an increase in illicit narcotic use.Combined with CDC guidelines, the curbing of opioid prescriptions to medically needed individuals, among non-opioid treatments, interventional techniques have been affected with declining utilization rates and medical policies reducing access to such modalities.

Conclusion: The opioid overdose waves over the past three decades have resulted from different etiologies. Wave one was associated with prescription opioid overdose deaths and wave two with the rise in heroin and overdose deaths from 1999 to 2013. Wave three was associated with a rise in synthetic opioid overdose deaths. Sadly, wave four continues to escalate with increasing number of deaths as a confluence of factors including the CDC guidelines, the COVID pandemic, increased availability of illicit synthetic opioids and the reduction of access to interventional techniques, which leads patients to seek remedies on their own.
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March 2022

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

Pain Physician 2021 01;24(S1):S27-S208

, Advanced Pain Institute, Covington, LA.

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.
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January 2021

Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain.

Pain Physician 2021 01;24(S1):S1-S26

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria.

Objective: To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain.

Methods: A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations.

Results: Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews.

Limitations: Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques.

Conclusion: This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.
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January 2021

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.

Pain Physician 2020 05;23(3S):S1-S127

Axis Spine Center, Coeur d'Alene, ID.

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.
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May 2020

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

Pain Physician 2019 11;22(6):E523-E550

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

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.
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November 2019

Update on Reversal and Decline of Growth of Utilization of Interventional Techniques In Managing Chronic Pain in the Medicare Population from 2000 to 2018.

Pain Physician 2019 11;22(6):521-536

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

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. 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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November 2019

Effectiveness of Percutaneous Adhesiolysis in Post Lumbar Surgery Syndrome: A Systematic Analysis of Findings of Systematic Reviews.

Pain Physician 2019 07;22(4):307-322

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: Post lumbar 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 are often contemplated in managing post lumbar surgery syndrome. Multiple previous systematic reviews have reached discordant conclusions about the level of evidence for the effectiveness of percutaneous adhesiolysis in managing post lumbar surgery syndrome and other conditions.

Study Design: A systematic review of previously published systematic reviews assessing efficacy of percutaneous adhesiolysis in managing post lumbar surgery syndrome.

Objective: To evaluate the value and validity of previous systematic reviews performed after 2015 on effectiveness of percutaneous adhesiolysis in managing chronic refractory low back and lower extremity pain secondary to post lumbar surgery syndrome.

Methods: Previous systematic reviews on percutaneous adhesiolysis were evaluated. The quality of each systematic review was assessed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews (AMSTAR).The randomized trials included in the available systematic reviews were assessed by Cochrane review criteria and Interventional Pain Management techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for methodologic quality.Data sources included relevant systematic reviews and the randomized trials included in those systematic reviews published since 2015 with searches of PubMed, Cochrane reviews, and Google Scholar through February 2019.

Outcome Measures: Outcome measures were significant improvement defined as 50% pain relief and improvement in functional status. Short-term efficacy was defined as improvement of 6 months or less, whereas long-term efficacy was defined as more than 6 months.

Results: Three systematic reviews and 4 randomized controlled trials (RCTs) of post lumbar surgery syndrome with chronic refractory low back and lower extremity pain showed notable evidence of significant pain relief. Only one systematic review, which was of low quality with inappropriate analysis, showed lack of evidence.

Conclusion: Overall, the present analysis shows Level I evidence for percutaneous adhesiolysis based on significant evidence from published RCTs and 3 of the 4 systematic reviews.

Key Words: Post lumbar surgery syndrome, epidural fibrosis, percutaneous adhesiolysis, systematic reviews, randomized controlled trials.
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July 2019

ASIPP Guidelines for Sedation and Fasting Status of Patients Undergoing Interventional Pain Management Procedures.

Pain Physician 2019 05;22(3):201-207

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY.

Many of the patients undergoing interventional procedures have daily regimens of medications including analgesics, muscle relaxants, and other drugs that can have significant additive/synergistic effects during the perioperative period. Further, many patients also present with comorbid states, including obesity, cardiovascular, and pulmonary disease. Consequently, in the perioperative period, a significant number of patients have suffered permanent neurologic injury, hypoxic brain injury, and even death as a result of over sedation, hypoventilation, and spinal cord injury. In addition, physicians are concerned about aspiration, subsequent complications, and as a result, they ask patients to fast for several hours prior to the procedures. Based on extensive literature and consensus, a minimum fasting period is established as 2 hours before a procedure for clear liquids and 4 hours before procedure for light meals, rather than having all patients fast for 8 hours or even fasting beginning at midnight the night before the procedure. Gastrointestinal stimulants, gastric acid secretion blockers, and antacids may be used, even though not routinely recommended. Due to the nature of chronic pain and anxiety, many patients undergoing interventional techniques may require mild to moderate sedation. Deep sedation and/or general anesthesia for most interventional procedures is considered as unsafe, since the patient cannot communicate acute changes in symptoms, thus, resulting in morbidity and mortality, as well as creating compliance issues. We are adapting the published standards of the American Society of Anesthesiologists for monitoring patients under sedation, regardless of the location of the procedure, either office-based, in a surgery center, or a hospital outpatient department. These standards include monitoring of blood pressure, cardiac rhythm, temperature, pulse oximetry, and continuous quantitative end tidal CO2 monitoring. Sedation must be provided either by qualified anesthesia or non-anesthesia providers, with appropriate understanding of the medications, drug interactions, and resuscitative protocols.KEY WORDS: Guidelines, sedation, fasting status, monitoring, neurological complications.
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May 2019

Therapeutic Role of Placebo: Evolution of a New Paradigm in Understanding Research and Clinical Practice.

Pain Physician 2017 07;20(5):363-386

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Research into interventional techniques in managing chronic spinal pain continues to be challenging, mystifying, confusing, and biased. Insight, or lack thereof, into placebo and nocebo phenomena contributes mightily to these difficulties. Unfortunately, placebo-nocebo responses are the subject of numerous controversies and challenges from not only a research perspective, but also clinical perspective. While interventionalists consider the biggest threat to interventional pain management research is inappropriate and outdated interpretation of the data, a greater problem is the misuse of the placebo response in research, with the declaration that all and everything as a placebo effect: with a misinterpretation of the nature of the placebo the, associated conclusions can be inaccurate.Researchers have been aware of placebo and nocebo effects for decades, even though misunderstandings and misgivings continue to be seen in scientific studies. In simplistic terms, placebo and nocebo had been understood to indicate improving or worsening of symptoms that occur during treatment with placebo/nocebo drugs or modalities. However, research has demonstrated that such terminology does not necessarily reflect "true" placebo effect or nocebo response. These effects are based on numerous factors, including natural course of a disease, spontaneous remission, regression to the mean, and a multitude of other conceptual, explanatory, and moral challenges. In modern clinical research, a neutral substance called placebo has been mainly used as a comparison factor rather than being studied itself, while the nocebo response has only been minimally studied.A major misconception involves active placebo, a concept that has been extended beyond the administration of inert substances. The definition of active placebo of an active agent given to a patient, even though the pharmacologic action of the active agent is not known to be beneficial, has been converted to conveniently change many of the treatments which are effective on their own to be defined as placebos, often leading to conclusions that none of the interventions are effective. This review focuses on a multitude of controversies surrounding placebo and nocebo phenomena in research and clinical applications. The discussion includes a focus on unsolved, forgotten, and ignored features of placebo responses in medicine, and provides an appropriate understanding of placebo and nocebo phenomena in interventional pain management. To that effect, this review also describes therapeutic placebos, research with open placebos, and improvements in understanding clinical applications of present interventional pain management research.
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July 2017

Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

Pain Physician 2017 02;20(2S):S3-S92

Georgia Pain Care, Atlanta, GA.

Background: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use.

Objectives: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique.

Methods: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."
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February 2017

Review of Controlled Substance Management in Chronic Pain: A Balanced Approach.

Authors:
Mark V Boswell

Pain Physician 2016 Nov-Dec;19(8):E1221-E1223

Department of Anesthesiology and Perioperative Medicine, University of Louisville.

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February 2018

Utilization of Facet Joint and Sacroiliac Joint Interventions in Medicare Population from 2000 to 2014: Explosive Growth Continues!

Curr Pain Headache Rep 2016 Oct;20(10):58

Department of Anesthesiology and Perioperative Medicine, University of Louisville, 530 S Jackson Street, Room C2A01, Louisville, KY, 40202, USA.

Increasing utilization of interventional techniques in managing chronic spinal pain, specifically facet joint interventions and sacroiliac joint injections, is a major concern of healthcare policy makers. We analyzed the patterns of utilization of facet and sacroiliac joint interventions in managing chronic spinal pain. The results showed significant increase of facet joint interventions and sacroiliac joint injections from 2000 to 2014 in Medicare FFS service beneficiaries. Overall, the Medicare population increased 35 %, whereas facet joint and sacroiliac joint interventions increased 313.3 % per 100,000 Medicare population with an annual increase of 10.7 %. While the increases were uniform from 2000 to 2014, there were some decreases noted for facet joint interventions in 2007, 2010, and 2013, whereas for sacroiliac joint injections, the decreases were noted in 2007 and 2013. The increases were for cervical and thoracic facet neurolysis at 911.5 % compared to lumbosacral facet neurolysis of 567.8 %, 362.9 % of cervical and thoracic facet joint blocks, 316.9 % of sacroiliac joints injections, and finally 227.3 % of lumbosacral facet joint blocks.
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http://dx.doi.org/10.1007/s11916-016-0588-2DOI Listing
October 2016

Innovations in interventional pain management of chronic spinal pain.

Expert Rev Neurother 2016 09 7;16(9):1033-42. Epub 2016 Jun 7.

c NeuroInterventional Services and Neuroendovascular Program , Massachusetts General Hospital and Harvard Medical School , Boston , MA , USA.

Introduction: Interventional pain management dates back to 1901, with significant innovations, which include the definition, literature synthesis, pathophysiology, and technical interventions.

Areas Covered: Interventional pain management and interventional techniques include neural blockade, neural ablative procedures, spinal cord and peripheral nerve stimulation, intrathecal drug delivery systems, minimally invasive lumbar decompression (MILD®), percutaneous endoscopic spinal decompression, and regenerative medicine. In addition, advances are also related to the evidence synthesis of comparative effectiveness research. Expert commentary: Multiple innovations in interventional pain management and potential innovations may reduce costs and improve care and outcomes with proper evidence synthesis and application of principles of evidence-based medicine. Innovations in interventional pain management in managing chronic spinal pain depend on extensive research and appropriate evidence synthesis. Innovations should be developed in conjunction with health care policy based on principles of evidence-based medicine.
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http://dx.doi.org/10.1080/14737175.2016.1194204DOI Listing
September 2016

Management of lumbar zygapophysial (facet) joint pain.

World J Orthop 2016 May 18;7(5):315-37. Epub 2016 May 18.

Laxmaiah Manchikanti, Pain Management Center of Paducah, Paducah, KY 42003, United States.

Aim: To investigate the diagnostic validity and therapeutic value of lumbar facet joint interventions in managing chronic low back pain.

Methods: The review process applied systematic evidence-based assessment methodology of controlled trials of diagnostic validity and randomized controlled trials of therapeutic efficacy. Inclusion criteria encompassed all facet joint interventions performed in a controlled fashion. The pain relief of greater than 50% was the outcome measure for diagnostic accuracy assessment of the controlled studies with ability to perform previously painful movements, whereas, for randomized controlled therapeutic efficacy studies, the primary outcome was significant pain relief and the secondary outcome was a positive change in functional status. For the inclusion of the diagnostic controlled studies, all studies must have utilized either placebo controlled facet joint blocks or comparative local anesthetic blocks. In assessing therapeutic interventions, short-term and long-term reliefs were defined as either up to 6 mo or greater than 6 mo of relief. The literature search was extensive utilizing various types of electronic search media including PubMed from 1966 onwards, Cochrane library, National Guideline Clearinghouse, clinicaltrials.gov, along with other sources including previous systematic reviews, non-indexed journals, and abstracts until March 2015. Each manuscript included in the assessment was assessed for methodologic quality or risk of bias assessment utilizing the Quality Appraisal of Reliability Studies checklist for diagnostic interventions, and Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool for therapeutic interventions. Evidence based on the review of the systematic assessment of controlled studies was graded utilizing a modified schema of qualitative evidence with best evidence synthesis, variable from level I to level V.

Results: Across all databases, 16 high quality diagnostic accuracy studies were identified. In addition, multiple studies assessed the influence of multiple factors on diagnostic validity. In contrast to diagnostic validity studies, therapeutic efficacy trials were limited to a total of 14 randomized controlled trials, assessing the efficacy of intraarticular injections, facet or zygapophysial joint nerve blocks, and radiofrequency neurotomy of the innervation of the facet joints. The evidence for the diagnostic validity of lumbar facet joint nerve blocks with at least 75% pain relief with ability to perform previously painful movements was level I, based on a range of level I to V derived from a best evidence synthesis. For therapeutic interventions, the evidence was variable from level II to III, with level II evidence for lumbar facet joint nerve blocks and radiofrequency neurotomy for long-term improvement (greater than 6 mo), and level III evidence for lumbosacral zygapophysial joint injections for short-term improvement only.

Conclusion: This review provides significant evidence for the diagnostic validity of facet joint nerve blocks, and moderate evidence for therapeutic radiofrequency neurotomy and therapeutic facet joint nerve blocks in managing chronic low back pain.
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http://dx.doi.org/10.5312/wjo.v7.i5.315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4865722PMC
May 2016

Epidural Injections for Lumbar Radiculopathy and Spinal Stenosis: A Comparative Systematic Review and Meta-Analysis.

Pain Physician 2016 Mar;19(3):E365-410

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Background: The prevalence of chronic low back pain and related disability is rapidly increasing as are the myriad treatments, including epidural injections. Even though epidural injections are one of the most commonly performed procedures in managing low back and lower extremity pain, starting in 1901 with local anesthetic alone, conflicting recommendations have been provided, despite the extensive literature. Recently Chou et al performed a technology assessment review for Agency for Healthcare Research and Quality (AHRQ) part of which was published in Annals of Internal Medicine showing lack of effectiveness of epidural steroid injections in managing lumbar radiculopathy and spinal stenosis. In contrast, multiple other publications have supported the efficacy and use of epidural injections.

Purpose: To assess the efficacy of 3 categories of epidural injections for lumbar and spinal stenosis: performed with saline with steroids, local anesthetic alone, or steroids with local anesthetic and separate facts from opinions.

Data Sources: PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed through August 2015.

Study Selection: Randomized trials, either placebo or active control, of epidural injections for lumbar radiculopathy and spinal stenosis.

Data Extraction: Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing principles of best evidence synthesis.

Data Synthesis: Thirty-nine randomized controlled trials met inclusion criteria. There were 9 placebo-controlled trials evaluating epidural corticosteroid injections, either with sodium chloride solution or bupivacaine, compared to placebo injections. There were 12 studies comparing local anesthetic alone to local anesthetic with steroid.

Results: A meta-analysis of 5 studies utilizing sodium chloride or bupivacaine with steroid showed a lack of efficacy.A comparison of lidocaine to lidocaine with steroids in 7 studies showed significant effectiveness from baseline to long-term follow-up periods. Meta-analysis showed a similar effectiveness for pain and function without non-inferiority of lidocaine compared to lidocaine with steroid at 3 months and 12 months.

Limitations: The review was restricted to the data available with at least 3 months of follow-up, which excluded some studies. The inclusion criteria were restricted to English language studies.

Conclusion: Epidural corticosteroid injections for radiculopathy or spinal stenosis with sodium chloride solution or bupivacaine were shown to be ineffective. Lidocaine alone or lidocaine in conjunction with steroids were significantly effective.
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March 2016

Appropriate design, methodological quality assessment, and clinically relevant outcomes are essential to determine the therapeutic role of epidural injections for low back pain and radiculopathy.

Evid Based Med 2016 06 17;21(3):89. Epub 2016 Feb 17.

Pain Management Center of Paducah, Paducah, Kentucky, USA; University of Louisville, Louisville, Kentucky, USA.

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http://dx.doi.org/10.1136/eb-2015-110310DOI Listing
June 2016

A Seamless Navigation to ICD-10-CM for Interventional Pain Physicians: Is a Rude Awakening Avoidable?

Pain Physician 2016 Jan;19(1):E1-14

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Since October 1, 2015, the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) was integrated into U.S. medical practices. This monumental transition seemingly occurred rather unceremoniously, despite significant opposition and reservations having been expressed by the provider community. In prior publications, we have described various survival strategies for interventional pain physicians. The regulators and beneficiaries of system-CMS, consultants, and health information technology industry are congratulating themselves for a job well done. Nonetheless, this transition comes at an immeasurable financial and psychological drain on providers. However, a rude awakening may be making its way with expiration of initial concessions from government and private payers.This manuscript provides a template for interventional pain management professionals with multiple steps for seamless navigation, including descriptions of the most commonly used codes, navigation through ICD-10-CM manual, steps for correct coding, and finally, detailed coding descriptions for various interventional techniques.
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January 2016

TO THE EDITOR.

Spine (Phila Pa 1976) 2016 Mar;41(5):E300

Clinical Professor of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, Kentucky, Medical Director, Pain Management Center of Paducah, Paducah, KYDepartment of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KYDepartment of Anesthesia, LSU Health Science Center, New Orleans, LANeuroInterventional Spine Service, Interventional Care, Massachusetts General Hospital, Associate Professor of Radiology, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1097/BRS.0000000000001400DOI Listing
March 2016

Cervical zygapophysial (facet) joint pain: effectiveness of interventional management strategies.

Postgrad Med 2016 Jan 10;128(1):54-68. Epub 2015 Dec 10.

b Department of Anesthesiology and Perioperative Medicine , University of Louisville , Louisville , KY , USA.

Diagnostic facet joint nerve blocks have been utilized in the diagnosis of cervical facet joint pain in patients without disk herniation or radicular pain due to a lack of reliable noninvasive diagnostic measures. Therapeutic interventions include intra-articular injections, facet joint nerve blocks and radiofrequency neurotomy. The diagnostic accuracy and effectiveness of facet joint interventions have been assessed in multiple diagnostic accuracy studies, randomized controlled trials (RCTs), and systematic reviews in managing chronic neck pain. This assessment shows there is Level II evidence based on a total of 11 controlled diagnostic accuracy studies for diagnosing cervical facet joint pain in patients without disk herniation or radicular pain utilizing controlled diagnostic blocks. Due to significant variability and internal inconsistency regarding prevalence in a heterogenous population; despite 11 studies, evidence is determined as Level II. Prevalence ranged from 36% to 67% with at least 80% pain relief as the criterion standard with a false-positive rate ranging from 27% to 63%. The evidence is Level II for the long-term effectiveness of radiofrequency neurotomy and facet joint nerve blocks in managing cervical facet joint pain. There is Level III evidence for cervical intra-articular injections.
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http://dx.doi.org/10.1080/00325481.2016.1105092DOI Listing
January 2016

Efficacy of Epidural Injections in Managing Chronic Spinal Pain: A Best Evidence Synthesis.

Pain Physician 2015 11;18(6):E939-1004

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

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 III 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 III 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 III 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.
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November 2015

Survival Strategies for Tsunami of ICD-10-CM for Interventionalists: Pursue or Perish!

Pain Physician 2015 Sep-Oct;18(5):E685-712

Massachusetts General Hospital and Harvard Medical School, Boston, MA.

The unfunded mandate for the implementation of International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) is scheduled October 1, 2015. The development of ICD-10-CM has been a complicated process. We have endeavored to keep Interventional Pain Management doctors apprised via a variety of related topical manuscripts. The major issues relate to the lack of formal physician participation in its preparation. While the American Health Information Management Association (AHIMA) and American Hospital Association (AHA) as active partners in its preparation. Centers for Medicare and Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) are major players; 3M and Blue Cross Blue Shield Association are also involved. The cost of ICD-10-CM implementation is high, similar to the implementation of electronic health records (EHRs), likely consuming substantial resources. While ICD-10, utilized worldwide, includes 14,400 different codes, ICD-10-CM, specific for the United States, has expanded to 144,000 codes, which also includes procedural coding system. It is imperative for physicians to prepare for the mandatory implementation. Conversion from ICD-9-CM to ICD-10-CM coding in interventional pain management is not a conversion of one to one that can be easily obtained from software packages. It is a both a difficult and time-consuming task with each physician, early on, expected to spend on estimation at least 10 minutes per visit on extra coding for established and new patients. For interventional pain physicians, there have been a multitude of changes, including creation of new codes and confusing conversion of existing codes. This manuscript describes a variety of codes that are relevant to interventional pain physicians and often utilized in daily practices. It is our objective that this manuscript will provide coding assistance to interventional pain physicians.
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June 2016

A Systematic Review and Best Evidence Synthesis of the Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain.

Pain Physician 2015 Jul-Aug;18(4):E535-82

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; LSU Health Science Center, New Orleans, LA; Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY; Manhattan Spine an.

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.
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February 2016

A Best-Evidence Systematic Appraisal of the Diagnostic Accuracy and Utility of Facet (Zygapophysial) Joint Injections in Chronic Spinal Pain.

Pain Physician 2015 Jul-Aug;18(4):E497-533

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; LSU Health Science Center, New Orleans, LA; Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY; Manhattan Spine an.

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.
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February 2016

The Tragedy of the Implementation of ICD-10-CM as ICD-10: Is the Cart Before the Horse or Is There a Tragic Paradox of Misinformation and Ignorance?

Pain Physician 2015 Jul-Aug;18(4):E485-95

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; LSU Health Science Center, New Orleans, LA; Spine Pain Diagnostics Associates, Niagara, WI; and 4Department of Anesthesiology and Perioperative Medicine, Univers.

The forced implementation of ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) codes that are specific to the United States, scheduled for implementation October 1, 2015, which is vastly different from ICD-10 (International Classification of Diseases, Tenth Revision), implemented worldwide, which has 14,400 codes, compared to ICD-10-CM with 144,000 codes to be implemented in the United States is a major concern to practicing U.S. physicians and a bonanza for health IT and hospital industry. This implementation is based on a liberal interpretation of the Health Insurance Portability and Accountability Act (HIPAA), which requires an update to ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and says nothing about ICD-10 or beyond. On June 29, 2015, the Supreme Court ruled that the Environmental Protection Agency unreasonably interpreted the Clean Air Act when it decided to set limits on the emissions of toxic pollutants from power plants, without first considering the costs on the industry. Thus, to do so is applicable to the medical industry with the Centers for Medicare and Medicaid Services (CMS) unreasonably interpreting HIPAA and imposing existent extensive regulations without considering the cost. In the United States, ICD-10-CM with a 10-fold increase in the number of codes has resulted in a system which has become so complicated that it no longer compares with any other country. Moreover, most WHO members use the ICD-10 system (not ICD-10-CM) only to record mortality in 138 countries or morbidity in 99 countries. Currently, only 10 countries employ ICD-10 (not ICD-10-CM) in the reimbursement process, 6 of which have a single payer health care system. Development of ICD-10-CM is managed by 4 non-physician groups, known as cooperating parties. They include the Centers for Disease Control and Prevention (CDC), CMS, the American Hospital Association (AHA), and the American Health Information Management Association (AHIMA). The AHIMA has taken the lead with the AHA just behind, both with escalating profits and influence, essentially creating a statutory monopoly for their own benefit. Further, the ICD-10-CM coalition includes 3M which will boost its revenues and profits substantially with its implementation and Blue Cross Blue Shield which has its own agenda. Physician groups are not a party to these cooperating parties or coalitions, having only a peripheral involvement. ICD-10-CM creates numerous deficiencies with 500 codes that are more specific in ICD-9-CM than ICD-10-CM. The costs of an implementation are enormous, along with maintenance costs, productivity, and cash disruptions.
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February 2016

Improved Operating Room Efficiency via Constraint Management: Experience of a Tertiary-Care Academic Medical Center.

J Am Coll Surg 2015 Jul 14;221(1):154-62. Epub 2015 Mar 14.

The Hiram C Polk Jr, MD, Department of Surgery, University of Louisville School of Medicine, Louisville, KY. Electronic address:

Background: Suboptimal operating room (OR) efficiency is a universal complaint among surgeons. Nonetheless, maximizing efficiency is critical to institutional success. Here, we report improvement achieved from low-cost, low-technology measures instituted within a tertiary-care academic medical center/Level I trauma center.

Study Design: Improvements in preadmission testing and OR scheduling, including appointing a senior nurse anesthetist to help direct OR use, were instituted in March 2012. A retrospective review of prospectively maintained OR case data was performed to evaluate time periods before and after program implementation, as well as to assess trends over time. Operating room performance metrics were compared using Mann-Whitney and chi-squared tests. Changes over time were analyzed using linear regression.

Results: Data including all surgical cases were available for a 36-month period; 10 months (6,581 cases) before program implementation and 26 months afterward (17,574 cases). Dramatic improvement was seen in first-case on-time starts, which increased from 39.3% to 83.8% (p < 0.0001). Additionally, the percent utilization of available OR time demonstrated a steady increase (p < 0.001). After an initial lag, case volume also improved, evident by an increase observed in the 12-month rolling average of cases per month (p < 0.001). The increase in case volume occurred during peak OR time (7 am to 5 pm), and did not result from adding cases after hours (5 pm to 11 pm).

Conclusions: After many years of what seemed an insoluble problem, simple changes fostering collaboration among services, including active management of the OR schedule and transparent data, have resulted in substantial improvement in OR efficiency and case volume.
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http://dx.doi.org/10.1016/j.jamcollsurg.2015.02.032DOI Listing
July 2015

Analysis of the carrot and stick policy of repeal of the sustainable growth rate formula: the good, the bad, and the ugly.

Pain Physician 2015 May-Jun;18(3):E273-92

Pain Management Center of Paducah, Paducah, KY, and University of Louisville; Premier Pain Centers, Shrewsbury, NJ and Johns Hopkins University School of Medicine, Baltimore, MD.

The Balanced Budget Act which became law in 1997 was designed to help stem the increasing in costs of healthcare. The Sustainable Growth Rate (SGR) formula was incorporated into that law as a method of helping balance the budget through a complex formula tying reimbursement to the growth in the economy. Soon after its inception, the flawed nature of the formula, linking the balancing of the federal budget to physician professional fees was realized. Congress has provided multiple short-term fixes known as SGR patches over the years so as to avoid generally progressively larger negative corrections to professional reimbursement. The near annual SGR correction requirement has been compared to Groundhog Day in the legislative arena. Over the years, physician and other providers faced numerous looming, large cuts. Most recently, on April 1, 2015 physicians faced a 21.2% cut in provider payments. To the surprise of many, in April 2015 a bipartisan bicameral effort permanently repealed the Medicare SGR formula for controlling provider payment. The repeal of SGR means the temporary measures to override the growth rate formula will no longer dominate Medicare policy discussions and now the focus turns to continue payment reforms. The MACRA provides physicians and other health care professionals with stable fee update for 5 years and it follows with a new incentive program, termed the Merit-based Incentive Payment System (MIPS) replacing and consolidating pre-existing incentive payment programs: meaningful use of electronic health records (EHR), physician quality reporting system, and the value-based payment modified. Thus, payments to clinicians will be subjected to adjustments based on participation in MIPS or other approved alternative payment mechanisms. This legislation also creates numerous other regulations. The MACRA has been criticized for providing insufficient statutory updates, enacting a flawed quality and performance improvement program associated with MIPS and inappropriate use of utilization and payment data. Thus, the MACRA offers physicians a predictable schedule for Medicare rates - a carrot, and controls the physician behaviors with payment reforms analogous to a stick. Thus, it could be said that this legislation embodies some good, bad, and ugly aspects.
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December 2015

Analysis of efficacy differences between caudal and lumbar interlaminar epidural injections in chronic lumbar axial discogenic pain: local anesthetic alone vs. local combined with steroids.

Int J Med Sci 2015 20;12(3):214-22. Epub 2015 Jan 20.

1. The Pain Management Center of Paducah, Paducah, KY, USA. ; 3. Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA.

Study Design: Comparative assessment of randomized controlled trials of caudal and lumbar interlaminar epidural injections in chronic lumbar discogenic pain.

Objective: To assess the comparative efficacy of caudal and lumbar interlaminar approaches of epidural injections in managing axial or discogenic low back pain.

Summary Of Background Data: Epidural injections are commonly performed utilizing either a caudal or lumbar interlaminar approach to treat chronic lumbar axial or discogenic pain, which is pain exclusive of that associated with a herniated intervertebral disc, or that is due to degeneration of the zygapophyseal joints, or due to dysfunction of the sacroiliac joints, respectively. The literature on the efficacy of epidural injections in managing chronic axial lumbar pain of presumed discogenic origin is limited.

Methods: The present analysis is based on 2 randomized controlled trials of chronic axial low back pain not caused by disc herniation, radiculitis, or facet joint pain, utilizing either a caudal or lumbar interlaminar approach, with a total of 240 patients studied, and a 24-month follow-up. Patients were assigned to receive either local anesthetic only or local anesthetic with a steroid in each 60 patient group.

Results: The primary outcome measure was significant improvement, defined as pain relief and functional status improvement of at least 50% from baseline, which was reported at 24-month follow-ups in 72% who received local anesthetic only with a lumbar interlaminar approach and 54% who received local anesthetic only with a caudal approach. In patients receiving local anesthetic with a steroid, the response rate was 67% for those who had a lumbar interlaminar approach and 68% for those who had a caudal approach at 12 months. The response was significantly better in the lumbar interlaminar group who received local anesthetic only, 77% versus 56% at 12 months and 72% versus 54% at 24 months.

Conclusion: This assessment shows that in patients with axial or discogenic pain in the lumbar spine after excluding facet joint and SI Joint pain, epidural injections of local anesthetic by the caudal or lumbar interlaminar approach may be effective in managing chronic low back pain with a potential superiority for a lumbar interlaminar approach over a caudal approach.
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http://dx.doi.org/10.7150/ijms.10870DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4323359PMC
November 2015

Medical journal peer review: process and bias.

Pain Physician 2015 Jan-Feb;18(1):E1-E14

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; LSU Health Science Center, New Orleans, LA.

Scientific peer review is pivotal in health care research in that it facilitates the evaluation of findings for competence, significance, and originality by qualified experts. While the origins of peer review can be traced to the societies of the eighteenth century, it became an institutionalized part of the scholarly process in the latter half of the twentieth century. This was a response to the growth of research and greater subject specialization. With the current increase in the number of specialty journals, the peer review process continues to evolve to meet the needs of patients, clinicians, and policy makers. The peer review process itself faces challenges. Unblinded peer review might suffer from positive or negative bias towards certain authors, specialties, and institutions. Peer review can also suffer when editors and/or reviewers might be unable to understand the contents of the submitted manuscript. This can result in an inability to detect major flaws, or revelations of major flaws after acceptance of publication by the editors. Other concerns include potentially long delays in publication and challenges uncovering plagiarism, duplication, corruption and scientific misconduct. Conversely, a multitude of these challenges have led to claims of scientific misconduct and an erosion of faith. These challenges have invited criticism of the peer review process itself. However, despite its imperfections, the peer review process enjoys widespread support in the scientific community. Peer review bias is one of the major focuses of today's scientific assessment of the literature. Various types of peer review bias include content-based bias, confirmation bias, bias due to conservatism, bias against interdisciplinary research, publication bias, and the bias of conflicts of interest. Consequently, peer review would benefit from various changes and improvements with appropriate training of reviewers to provide quality reviews to maintain the quality and integrity of research without bias. Thus, an appropriate, transparent peer review is not only ideal, but necessary for the future to facilitate scientific progress.
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November 2015
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