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.

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.

Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review.

BACKGROUND: As part of a comprehensive nonsurgical approach, epidural injections often are used in the management of lumbar disc herniation. Recent guidelines and systematic reviews have reached different conclusions about the efficacy of epidural injections in managing lumbar disc herniation. QUESTIONS/PURPOSES: In this systematic review, we determined the efficacy (pain relief and functional improvement) of the three anatomic approaches (caudal, lumbar interlaminar, and transforaminal) for epidural injections in the treatment of disc herniation. METHODS: We performed a literature search from 1966 to June 2013 in PubMed, Cochrane library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references for trials studying all types of epidural injections in managing chronic or chronic and subacute lumbar disc herniation. We wanted only randomized controlled trials (RCTs) (either placebo or active controlled) to be included in our analysis, and 66 studies found in our search fulfilled these criteria. We then assessed the methodologic quality of these 66 studies using the Cochrane review criteria for RCTs. Thirty-nine studies were excluded, leaving 23 RCTs of high and moderate methodologic quality for analysis. Evidence for the efficacy of all three approaches for epidural injection under fluoroscopy was strong for short-term (< 6 months) and moderate for long-term (≥ 6 months) based on the Cochrane rating system with five levels of evidence (best evidence synthesis), with strong evidence denoting consistent findings among multiple high-quality RCTs and moderate evidence denoting consistent findings among multiple low-quality RCTs or one high-quality RCT. The primary outcome measure was pain relief, defined as at least 50% improvement in pain or 3-point improvement in pain scores in at least 50% of the patients. The secondary outcome measure was functional improvement, defined as 50% reduction in disability or 30% reduction in the disability scores. RESULTS: Based on strong evidence for short-term efficacy from multiple high-quality trials and moderate evidence for long-term efficacy from at least one high quality trial, we found that fluoroscopic caudal, lumbar interlaminar, and transforaminal epidural injections were efficacious at managing lumbar disc herniation in terms of pain relief and functional improvement. CONCLUSIONS: The available evidence suggests that epidural injections performed under fluoroscopy by trained physicians offer improvement in pain and function in well-selected patients with lumbar disc herniation.

Epidemiology of low back pain in adults.

OBJECTIVE: Low back pain affects many individuals. It has profound effects on well-being and is often the cause of significant physical and psychological health impairments. Low back pain also affects work performance and social responsibilities, such as family life, and is increasingly a major factor in escalating health-care costs. A global review of the prevalence of low back pain in the adult general population has shown its point prevalence to be approximately 12%, with a one-month prevalence of 23%, a one-year prevalence of 38%, and a lifetime prevalence of approximately 40%. Furthermore, as the population ages over the coming decades, the number of individuals with low back pain is likely to increase substantially. This comprehensive review is undertaken to assess the increasing prevalence of low back pain and the influence of comorbid factors, along with escalating costs. MATERIALS AND METHODS: A narrative review with literature assessment. RESULTS: In the USA, low back pain and related costs are escalating. Based on the available literature, it appears that the prevalence of low back pain continues to increase, along with numerous modalities and their application in managing low back pain. Comorbid factors with psychological disorders and multiple medical problems, including obesity, smoking, lack of exercise, increasing age, and lifestyle factors, are considered as risk factors for low back pain. CONCLUSION: Although it has been alleged that low back pain resolves in approximately 80% to 90% of patients in about six weeks, irrespective of the administration or type of treatment, with only 5% to 10% of patients developing persistent back pain, this concept has been frequently questioned as the condition tends to relapse and most patients experience multiple episodes years after the initial attack.

Long-term results of percutaneous lumbar decompression mild(®) for spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) generally occurs from a combination of degenerative changes occurring in the lumbar spine. These include hypertrophy of ligamentum flavum, facet joint arthritic changes and bulging of the intervertebral disk. Spinal stenosis leads to compression of the lumbar neural elements (cauda equina), which manifests as low back and leg pain especially on standing and walking known as "neurogenic claudication." Current treatment options for LSS are varied. Conservative management, including physical therapy with/without epidural steroid injections, may be adequate for mild stenosis. Surgical decompression is reserved for severe cases and results in variable degrees of success. Patients with moderate-to-severe LSS having ligamentum flavum hypertrophy as a key contributor are generally inappropriately treated or undertreated. This is due to ineffectiveness of conservative therapy and possibility that major surgical compression might be too aggressive. Percutaneous decompression offers a possible solution for this patient population. METHODS: One-year follow-up study was conducted at 11 U.S. sites. Study cohort included 58 mild(®) percutaneous decompression patients who underwent 170 procedures, the majority treated bilaterally at one or two lumbar levels. Outcome measures included the visual analog scale (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2(®) Health Survey. RESULTS: No major mild(®) device or procedure-related complications were reported. One-year data showed significant reduction of pain as measured by VAS. Improvement in physical functionality, mobility, and disability was significant as measured by ZCQ, SF-12v2, and ODI. CONCLUSIONS: At 1 year this 58-patient cohort demonstrated continued excellent safety profile of the mild(®) procedure and equally important, showed long-term pain relief and improved functionality.

Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 3: systematic reviews and meta-analyses of randomized trials.

In recent years, progress and innovations in healthcare are measured by evidence-based medicine (EBM), systematic reviews, and meta-analyses. A systematic review is defined as, "the application of scientific strategies that limit bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic." In contrast, meta-analysis is the statistical pooling of data across studies to generate pooled estimates of effects. Meta-analysis usually is the final step in a systematic review. Systematic reviews and meta-analyses are labor intensive, requiring expertise in both the subject matter and review methodology, and also must follow the rules of EBM which suggest that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research effectively. While expertise in the subject matter is crucial, expertise in review methods is also particularly important. Despite an explosion of systematic reviews and meta-analyses, the empiric research on the quality of systematic reviews has shown that not all systematic reviews are truly systematic, having highly variable quality, deficiencies in methodologic assessment of the quality of the included manuscripts, and bias. Even then, systematic review of the literature is currently the best, least biased and most rational way to organize, cull, evaluate, and integrate the research evidence from among the expanding medical and healthcare literature. However, a dangerous discrepancy between the experts and the evidence continues to persist in part because multiple instruments are available to assess the quality of systematic reviews or meta-analyses. Steps in conducting systematic reviews include planning, conducting, reporting, and disseminating the results. The Quality of Reporting of Meta-analysis (QUOROM) statement provides a checklist and a flow diagram. The checklist describes the preferred way to present the abstract, introduction, methods, results, and discussion sections of the report of an analysis. This review describes various aspects of systematic reviews and meta-analyses of randomized trials with a special focus on interventional pain management.

Systematic review of the effectiveness of thermal annular procedures in treating discogenic low back pain.

BACKGROUND: Chronic discogenic low back pain is a common problem with significant personal and societal costs. Thermal annular procedures (TAPs) have been developed in an effort to provide a minimally invasive treatment for this disorder. Multiple techniques utilized are intradiscal electrothermal therapy (IDET), radiofrequency annuloplasty, and intradiscal biacuplasty (IDB). However, these treatments continue to be controversial, coupled with a paucity of evidence. STUDY DESIGN: A systematic review of the literature evaluating the efficacy or effectiveness of TAPs. OBJECTIVE: To determine the effectiveness of TAPs in reducing low back pain in patients with intradiscal disorders. METHODS: A comprehensive evaluation of the literature relating to TAPs was performed. The literature was evaluated according to Cochrane Review criteria for randomized controlled trials (RCTs) and according to the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Pain relief was the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Data sources included relevant literature of the English language identified through searches of PubMed, EMBASE, the Cochrane Library, and the Database of Reviews of Effectiveness (DARE). OUTCOME MEASURES: Short-term effectiveness was defined as one-year or less and long-term effectiveness was defined as greater than one-year. RESULTS: Systematic review of IDET identified 2 RCTs and 16 observational studies with an indicated evidence of Level II-2. Systematic review of radiofrequency annuloplasty identified no RCTs but 2 observational studies with an uncertain evidence of Level II-3. Systematic review of IDB identified one pilot study. The level of evidence is lacking with Level III. LIMITATIONS: The limitations of this review include paucity of the literature and lack of evidence with internal validity and generalizability. CONCLUSION: IDET offers functionally significant relief in approximately one-half of appropriately chosen chronic discogenic low back pain patients. There is minimal evidence supporting the use of radiofrequency annuloplasty and IDB.

Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain.

BACKGROUND: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%, and 14% of the patients reporting grade II to IV neck pain with high pain intensity and disability that has a substantial impact on health care and society. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant and no systematic review dedicated to the evaluation of cervical interlaminar epidurals has been performed in the past. STUDY DESIGN: A systematic review of cervical interlaminar epidural injections. OBJECTIVE: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. METHODS: The available literature of cervical interlaminar epidural injections in managing chronic neck and upper extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of 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. RESULTS: The indicated evidence is Level II-1 in managing chronic neck and upper extremity pain with 1C/strong recommendation. LIMITATIONS: The limitations of this systematic review include the paucity of literature and lack of randomized trials performed under fluoroscopy. CONCLUSION: The results of this systematic evaluation of cervical interlaminar epidural injection showed significant effect in relieving chronic intractable pain of cervical origin and also providing long-term relief with an indicated evidence level of Level II-1.

Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome.

BACKGROUND: Post lumbar surgery syndrome or failed back surgery syndrome with persistent pain continues to increase over the years. The speculated causes of post lumbar laminectomy syndrome include acquired stenosis, epidural fibrosis, arachnoiditis, radiculopathy, and recurrent disc herniation. Epidural fibrosis may account for as much as 20% to 36% of all cases of failed back surgery syndrome. Percutaneous epidural adhesiolysis has been employed in interventional pain management in the treatment of chronic, refractory low back and lower extremity pain after back surgery. STUDY DESIGN: A systematic review of randomized trials and observational studies. OBJECTIVE: To evaluate the effectiveness of percutaneous adhesiolysis in managing chronic low back and lower extremity pain due to post lumbar surgery syndrome. METHODS: A comprehensive literature search was conducted utilizing electronic databases, as well as systematic reviews and cross references from 1966 through December 2008. The quality of individual articles used in this analysis was assessed by modified Cochrane review criteria for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for assessment of observational studies. Clinical relevance was evaluated using 5 questions according to the criteria recommended by the Cochrane Review Back Group. Analysis was conducted using 5 levels of evidence, ranging from Level I to III, with 3 subcategories in Level II. OUTCOME PARAMETERS: The primary outcome measure was pain relief (short-term relief of at least 6 months and long-term relief of more than 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and change in opioid intake. RESULTS: Of the 13 studies considered for inclusion, 3 randomized trials and 4 observational studies met the inclusion criteria for methodologic quality assessment and evidence synthesis based on methodologic quality scores of 50 or more. Evidence of percutaneous adhesiolysis in the management of chronic low back pain in post-lumbar surgery syndrome is Level I to Level II-1, with evidence derived from 3 randomized trials. LIMITATIONS: There is a paucity of efficacy and pragmatic trials. No trials have been published after 2006. CONCLUSION: The indicated level of evidence for percutaneous adhesiolysis is Level I or II-1 based on the US Preventative Services Task Force (USPSTF) criteria.

Effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome: a systematic review.

BACKGROUND: Post lumbar surgery syndrome with persistent chronic low back and lower extremity pain is common in the United States. Epidural fibrosis may account for as much as 20% to 36% of all cases of failed back surgery syndrome (FBSS). Percutaneous adhesiolysis with a catheter or direct visualization of the spinal canal and the contents with an endoscope are techniques employed in resistant cases when patients fail to respond to conservative modalities of treatment, including fluoroscopically directed epidural injections. Some patients failing to respond to percutaneous adhesiolysis are candidates for spinal endoscopic adhesiolysis. However, literature evaluating the effectiveness of spinal endoscopic adhesiolysis is sparse and discussions continue about its effectiveness, utility, and complications. STUDY DESIGN: A systematic review of the available literature. OBJECTIVE: To evaluate the effectiveness and safety of spinal endoscopic adhesiolysis in the management of chronic low back and lower extremity pain in post surgical patients with chronic recalcitrant pain, non-responsive to conservative modalities of management and fluoroscopically directed epidural injections. METHODS: A search of relevant resources (PubMed, EMBASE, and the Cochrane database) was accomplished and the resulting publications were examined based on the inclusion/exclusion criteria set forth. Randomized controlled trials and observational studies were included in the search. Two reviewers assessed the studies' methodologies and outcomes. Randomized clinical trials were assessed and scored based on the criteria established by the Cochrane methodological assessment criteria of randomized clinical trials and the observational studies were assessed and scored based on the Agency for Healthcare Research and Quality (AHRQ) criteria. Clinical relevance was evaluated utilizing Cochrane review criteria. Analysis was conducted using 5 levels of evidence, ranging from Level I to III, with 3 subcategories in Level II. OUTCOME MEASURES: The primary outcome measure was pain relief (> or = 50%) in follow-up for at least 6 months. Pain relief for longer than 6 months was considered long-term and 6 months or less was considered short-term. The secondary outcome measures were functional and psychological status, return to work, patient satisfaction, and opioid intake. RESULTS: Of the 13 studies considered for inclusion, one randomized trial and 5 observational studies met inclusion criteria for evidence synthesis based on the inclusion criteria and methodologic quality scores of 50 or more. The indicated level of evidence for endoscopic adhesiolysis is Level II-1 or II-2 evidence for short- and long-term relief based on the U.S. Preventive Services Task Force (USPSTF) criteria. LIMITATIONS: There was a paucity of literature for randomized trials. CONCLUSION: Spinal endoscopic adhesiolysis may be used as an effective treatment modality for chronic refractory low back pain and radiculopathy that is related to epidural adhesions.

Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review.

BACKGROUND: Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand. STUDY DESIGN: A systematic review of SCS in patients with failed back surgery syndrome. OBJECTIVES: This systematic review is undertaken to examine the evidence from randomized controlled trials (RCTs) and observational studies to evaluate the effectiveness of SCS in post lumbar surgery syndrome and to demonstrate clinical and cost effectiveness. METHODS: Review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The 5 levels of evidence were classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to December 2008, and manual searches of bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief < or = one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized. RESULTS: The indicated evidence is Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome. LIMITATIONS: The limitations of this review included the paucity and heterogeneity of the literature. CONCLUSION: This systematic review evaluating the effectiveness of SCS in relieving chronic intractable pain of failed back surgery syndrome indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis.

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

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

Responsible, Safe, and Effective Use of Antithrombotics and Anticoagulants in Patients Undergoing Interventional Techniques: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Interventional pain management involves diagnosis and treatment of chronic pain. This specialty utilizes minimally invasive procedures to target therapeutics to the central nervous system and the spinal column. A subset of patients encountered in interventional pain are medicated using anticoagulant or antithrombotic drugs to mitigate thrombosis risk. Since these drugs target the clotting system, bleeding risk is a consideration accompanying interventional procedures. Importantly, discontinuation of anticoagulant or antithrombotic drugs exposes underlying thrombosis risk, which can lead to significant morbidity and mortality especially in those with coronary artery or cerebrovascular disease. This review summarizes the literature and provides guidelines based on best evidence for patients receiving anti-clotting therapy during interventional pain procedures. STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To provide a current and concise appraisal of the literature regarding an assessment of the bleeding risk during interventional techniques for patients taking anticoagulant and/or antithrombotic medications. METHODS: A review of the available literature published on bleeding risk during interventional pain procedures, practice patterns and perioperative management of anticoagulant and antithrombotic therapy was conducted. Data sources included relevant literature identified through searches of EMBASE and PubMed from 1966 through August 2018 and manual searches of the bibliographies of known primary and review articles. RESULTS: 1. There is good evidence for risk stratification by categorizing multiple interventional techniques into low-risk, moderate-risk, and high-risk. Also, their risk should be upgraded based on other risk factors.2. There is good evidence for the risk of thromboembolic events in patients who interrupt antithrombotic therapy. 3. There is good evidence supporting discontinuation of low dose aspirin for high risk and moderate risk procedures for at least 3 days, and there is moderate evidence that these may be continued for low risk or some intermediate risk procedures.4. There is good evidence that discontinuation of anticoagulant therapy with warfarin, heparin, dabigatran (Pradaxa®), argatroban (Acova®), bivalirudin (Angiomax®), lepirudin (Refludan®), desirudin (Iprivask®), hirudin, apixaban (Eliquis®), rivaroxaban (Xarelto®), edoxaban (Savaysa®, Lixiana®), Betrixaban(Bevyxxa®), fondaparinux (Arixtra®) prior to interventional techniques with individual consideration of pharmacokinetics and pharmacodynamics of the drugs and individual risk factors increases safety.5. There is good evidence that diagnosis of epidural hematoma is based on severe pain at the site of the injection, rapid neurological deterioration, and MRI with surgical decompression with progressive neurological dysfunction to avoid neurological sequelae.6. There is good evidence that if thromboembolic risk is high, low molecular weight heparin bridge therapy can be instituted during cessation of the anticoagulant, and the low molecular weight heparin can be discontinued 24 hours before the pain procedure.7. There is fair evidence that the risk of thromboembolic events is higher than that of epidural hematoma formation with the interruption of antiplatelet therapy preceding interventional techniques, though both risks are significant.8. There is fair evidence that multiple variables including anatomic pathology with spinal stenosis and ankylosing spondylitis; high risk procedures and moderate risk procedures combined with anatomic risk factors; bleeding observed during the procedure, and multiple attempts during the procedures increase the risk for bleeding complications and epidural hematoma.9. There is fair evidence that discontinuation of phosphodiesterase inhibitors is optional (dipyridamole [Persantine], cilostazol [Pletal]. However, there is also fair evidence to discontinue Aggrenox [dipyridamole plus aspirin]) 3 days prior to undergoing interventional techniques of moderate and high risk. 10. There is fair evidence to make shared decision making between the patient and the treating physicians with the treating physician and to consider all the appropriate risks associated with continuation or discontinuation of antithrombotic or anticoagulant therapy.11. There is fair evidence that if thromboembolic risk is high antithrombotic therapy may be resumed 12 hours after the interventional procedure is performed.12. There is limited evidence that discontinuation of antiplatelet therapy (clopidogrel [Plavix®], ticlopidine [Ticlid®], Ticagrelor [Brilinta®] and prasugrel [Effient®]) avoids complications of significant bleeding and epidural hematomas.13. There is very limited evidence supporting the continuation or discontinuation of most NSAIDs, excluding aspirin, for 1 to 2 days and some 4 to 10 days, since these are utilized for pain management without cardiac or cerebral protective effect. LIMITATIONS: The continued paucity of the literature with discordant recommendations. CONCLUSION: Based on the survey of current literature, and published clinical guidelines, recommendations for patients presenting with ongoing antithrombotic therapy prior to interventional techniques are variable, and are based on comprehensive analysis of each patient and the risk-benefit analysis of intervention. KEY WORDS: Perioperative bleeding, bleeding risk, practice patterns, anticoagulant therapy, antithrombotic therapy, interventional techniques, safety precautions, pain.

Corticosteroid induced psychosis in the pain management setting.

BACKGROUND: Synthetic corticosteroids are commonly utilized in interventional pain management procedures. These substances have potential side-effects including psychological adverse events. OBJECTIVE: We describe a case of substance-induced psychotic disorder resulting from corticosteroids administration. DESIGN: Case Report. METHODS: We describe a 67-year-old male that, six months prior to being consulted at our center, received a cervical epidural, 4 level medial branch blocks, 4 trigger point injections and a tendon injection in the shoulder all including corticosteroids all in one treatment session. RESULTS: Approximately 7 days following the multiple injections, the patient developed psychotic episodes including racing thoughts, anger, agitation, pressured hyperverbal speech and paranoia. The symptoms spontaneously resolved in approximately 7-10 days. DISCUSSION: Although well known as a potential complication, corticosteroid induced psychosis secondary to interventional pain procedures have never been reported. We further discuss this potential side effect of utilizing corticosteroids and emphasize the need for guidelines regarding steroid utilization.

Reassessment of evidence synthesis of occupational medicine practice guidelines for interventional pain management.

BACKGROUND: Appropriately developed practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatments, which include the application of multiple methods for collecting and evaluating evidence for a wide range of clinical interventions and disciplines. However, the guidelines are neither infallible, nor a substitute for clinical judgment. While the guideline development process is a complex phenomenon, conflict of interest in guideline development and inappropriate methodologies must be avoided. It has been alleged that the guidelines by the American College of Occupational and Environmental Medicine (ACOEM) prevent injured workers from receiving the majority of medically necessary and appropriate interventional pain management services. An independent critical appraisal of both chapters of the ACOEM guidelines showed startling findings with a conclusion that these guidelines may not be applied in patient care as they scored below 30% in the majority of evaluations utilizing multiple standardized criteria. OBJECTIVE: To reassess the evidence synthesis for the ACOEM guidelines for the low back pain and chronic pain chapters utilizing an expanded methodology, which includes the criteria included in the ACOEM guidelines with the addition of omitted literature and application of appropriate criteria. METHODS: For reassessment, randomized trials were utilized as it was in the preparation of the guidelines. In this process, quality of evidence was assessed and recommendations were made based on grading recommendations of Guyatt et al. The level of evidence was determined utilizing the quality of evidence criteria developed by the U.S. Preventive Services Task Force (USPSTF), as well as the outdated quality of evidence criteria utilized by ACOEM in the guideline preparation. Methodologic quality of each individual article was assessed utilizing the Agency for Healthcare Research and Quality (AHRQ) methodologic assessment criteria for diagnostic interventions and Cochrane methodologic quality assessment criteria for therapeutic interventions. RESULTS: The results of reassessment are vastly different from the conclusions derived by the ACOEM guidelines. The differences in strength of rating for the diagnosis of discogenic pain by provocation discography and facet joint pain by diagnostic facet joint nerve blocks is established with strong evidence. Therapeutic cervical and lumbar medial branch blocks and radiofrequency neurolysis, therapeutic thoracic medial branch blocks, cervical interlaminar epidural steroid injections, caudal epidural steroid injections, lumbar transforaminal epidural injections, percutaneous and endoscopic adhesiolysis, and spinal cord stimulation qualified for moderate to strong evidence. Additional insight is also provided for evidence rating for intradiscal electrothermal therapy (IDET), automated percutaneous disc decompression, and intrathecal implantables. CONCLUSION: The reassessment and reevaluation of the low back and chronic pain chapters of the ACOEM guidelines present results that are vastly different from the published and proposed guidelines. Contrary to ACOEM's conclusions of insufficient evidence for most interventional techniques, the results illustrate moderate to strong evidence for most diagnostic and therapeutic interventional techniques.

Reframing Medicare Physician Payment Policy for 2019: A Look at Proposed Policy.

On July 12, 2018, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2019 Medicare physician fee schedule and quality payment program, combining these 2 rules for the first time. This occurred in a milieu of changing regulations that have been challenging for interventional pain management specialists. The Affordable Care Act (ACA) continuous to be amended by multiple administrative changes. This July 12th rule proposes substantial payment changes for evaluation and management (E&M) services, with documentation requirements, and blending of Level II to V CPT codes for E&M into a single payment. In addition, various changes in the quality payment program with liberalization of some metrics have been published. Recognizing that there are differing impacts based on specialty and practice type, as a whole interventional pain management specialists would likely see favorable reimbursement trends for E&M services as a result of this proposal. Moreover, in comparison with recent CMS final ruling, this proposed rule has relatively limited changes in procedural reimbursement performed in a facility or in-office setting.CMS, in the new rule, has proposed an overhaul of the E&M documentation and coding system ostensibly to reduce the amount of time physicians are required to spend inputting information into patients' records. The new proposed rule blends Level II to V codes for E&M services into a single payment of $93 for office outpatient visits for established patients and $135 for new patient visits. This will also have an effect with blended payments for services provided in hospital outpatients. CMS also has provided additional codes to increase the reimbursement when prolonged services are provided with total reimbursement coming to Level V payments. Interventional pain management-centered care has been identified as a specialty with complexity inherent to E&M associated with these services. Among the procedural payments, there exist significant discrepancies for the services performed in hospitals, ambulatory surgery centers (ASCs), and offices. A particularly egregious example is peripheral neurolytic blocks, which is reimbursed at 1,800% higher in hospital outpatient department (HOPD) settings as compared with procedures done in the office. The majority of hospital based procedures have faced relatively small cuts as compared with office based practice. The only significant change noted is for spinal cord stimulator implant leads when performed in office setting with 19.2% increase. However, epidural codes, which have been initiated with a lower payment, continue to face small reductions for physician portion.This review describes the effects of the proposed policy on interventional pain management reimbursement for E&M services, procedural services by physicians and procedures performed in office settings. KEY WORDS: Physician payment policy, physician fee schedule, Medicare, Merit-Based Incentive Payment System, interventional pain management, regulatory tsunami, Medicare Access and CHIP Reauthorization Act of 2015.

Reframing the Prevention Strategies of the Opioid Crisis: Focusing on Prescription Opioids, Fentanyl, and Heroin Epidemic.

The opioid epidemic has been called the "most consequential preventable public health problem in the United States." Though there is wide recognition of the role of prescription opioids in the epidemic, evidence has shown that heroin and synthetic opioids contribute to the majority of opioid overdose deaths. It is essential to reframe the preventive strategies in place against the opioid crisis with attention to factors surrounding the illicit use of fentanyl and heroin. Data on opioid overdose deaths shows 42,000 deaths in 2016. Of these, synthetic opioids other than methadone were responsible for over 20,000, heroin for over 15,000, and natural and semi-synthetic opioids other than methadone responsible for over 14,000. Fentanyl deaths increased 520% from 2009 to 2016 (increased by 87.7% annually between 2013 and 2016), and heroin deaths increased 533% from 2000 to 2016. Prescription opioid deaths increased by 18% overall between 2009 and 2016. The Drug Enforcement Administration (DEA) mandated reductions in opioid production by 25% in 2017 and 20% in 2018. The number of prescriptions for opioids declined significantly from 252 million in 2013 to 196 million in 2017 (9% annual decline over this period), falling below the number of prescriptions in 2006. In addition, data from 2017 shows significant reductions in the milligram equivalence of morphine by 12.2% and in the number of patients receiving high dose opioids by 16.1%. This manuscript describes the escalation of opioid use in the United States, discussing the roles played by drug manufacturers and distributors, liberalization by the DEA, the Food and Drug Administration (FDA), licensure boards and legislatures, poor science, and misuse of evidence-based medicine. Moreover, we describe how the influence of pharma, improper advocacy by physician groups, and the promotion of literature considered peer-reviewed led to the explosive use of illicit drugs arising from the issues surrounding prescription opioids.This manuscript describes a 3-tier approach presented to Congress. Tier 1 includes an aggressive education campaign geared toward the public, physicians, and patients. Tier 2 includes facilitation of easier access to non-opioid techniques and the establishment of a National All Schedules Prescription Electronic Reporting Act (NASPER). Finally, Tier 3 focuses on making buprenorphine more available for chronic pain management as well as for medication-assisted treatment. KEY WORDS: Opioid epidemic, fentanyl and heroin epidemic, prescription opioids, National All Schedules Prescription Electronic Reporting Act (NASPER), Prescription Drug Monitoring Programs (PDMPs).

Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS. METHODS: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use. RESULTS: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial. CONCLUSION: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.