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Introduction/Background* Platinum in combination with paclitaxel (P) and bevacizumab is the standard of care in first-line recurrent/advanced cervical cancer (Tewari, NEJM 2020). Nintedanib is an oral tyrosine kinase inhibitor targeting, among others, vascular endothelial growth factor receptor. Methodology Double-blind phase II randomised study in patients with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer. Patients received carboplatin AUC 5-6 and paclitaxel 175mg/m2 q 3 weeks with oral nintedanib 200 mg BID/placebo. Stratification factor was primary advanced versus recurrent disease. The primary endpoint was progression-free survival (PFS) at 1,5 years with at least 87 events and α=0.15, β=80%, one sided, in favor of the nintedanib (N) versus control (C) arm. The study (NCT02009579) was performed according to the ENGOT model A. Result(s)* 120 patients (62 N, 58 C) were randomised between March 2014 and October 2018. Median follow-up was 35 months. Baseline characteristics were similar in both groups (total population: squamous cell carcinoma 62%, prior radiotherapy 64%, primary advanced 25%, recurrent 75%). The primary endpoint was met with a PFS at 1.5 years of 15.1% versus 12.8% in favour of the nintedanib arm (p = 0.057). Median overall survival (OS) was 21.7 and 16.4 months for N and C, respectively. Subgroup analysis did not demonstrate a difference in PFS in the primary advanced setting, but in the recurrent setting the 1 year PFS was 22.8% and 14.9% for N and C, respectively. Confirmed RECIST response rate was 48% for N and 39% for C. No new adverse events were noted for N. However N was associated with numerically more serious adverse events for anemia and febrile neutropenia. Discontinuation of chemotherapy was similar in both groups. N was discontinued in 3% versus placebo in 1.6% of the patients. Dose reduction of N was necessary in 53% of the patients. Conclusion* The study met its primary endpoint with a prolonged PFS in the N arm. No new safety signals were observed.

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

Background: The intervertebral disc has been implicated as a major cause of chronic spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients, and in 16% to 53% of patients with pain in the cervical spine. Lumbar, cervical, and thoracic provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature on point, intense debate continues about lumbar discography as a diagnostic tool. Study Design: A systematic review of the diagnostic accuracy of lumbar, cervical, and thoracic provocation and analgesic discography literature. Objective: To systematically assess and re-evaluate the diagnostic accuracy of lumbar, cervical, and thoracic discography. Methods: The available literature on discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. To assess the level of evidence, a modified grading of qualitative evidence criteria was utilized, with grading of evidence into 5 categories from Level I to Level V incorporating evidence obtained from multiple high quality diagnostic accuracy studies for Level I and opinion or consensus of a large group of clinicians and/or scientists for Level V. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2017, and manual searches of the bibliographies of known primary and review articles. Results: Over 100 manuscripts were considered for inclusion. Of these, 8 studies met inclusion criteria for diagnostic accuracy and prevalence with 5 studies assessing lumbar provocation discography and 3 studies assessing cervical discography. The results showed variable prevalence from 16.9% to 26% for discogenic pain and 16.9% to 42% for internal disc disruption. The cervical discogenic pain prevalence ranged from 16% to 53%. Based on methodological quality assessment criteria the strength of evidence for lumbar provocation discography is Level III and for cervical discogenic pain is Level IV. Limitations: Despite multiple publications in the lumbar spine, value and validity of discography continues to be debated. In reference to cervical and thoracic discography, the available literature and value and validity continues to be low. Conclusion: This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. The evidence is weaker for cervical and nonexistent for thoracic discography. Key words: Lumbar intervertebral disc, cervical intervertebral disc, thoracic intervertebral disc, discography, provocation discography, analgesic discography, diagnostic accuracy, prevalence

Background: Treatment of chronic hepatitis B (CHB) with polymerase inhibitors is key to prevent disease flares and progression toward advanced liver disease. Efficacy and tolerability of newer agents has been reported anecdotally in transplant recipients. Methods: In this prospective, observational study, we assessed outcomes of therapy with tenofovir (TDF), entecavir (ETV), and telbivudine (LdT) in 13 heart transplant recipients (HTR) with CHB. Results: Most patients were hepatitis B e antigen negative, had low baseline hepatitis B virus (HBV) DNA, and normal aminotransferases. Liver biopsy showed a median fibrosis score of 1.5 (range 0–4). Glomerular filtration rate (GFR) was

The MINiature Exoplanet Radial Velocity Array (MINERVA) is a dedicated observatory of four 0.7m robotic telescopes fiber-fed to a KiwiSpec spectrograph. The MINERVA mission is to discover super-Earths in the habitable zones of nearby stars. This can be accomplished with MINERVA's unique combination of high precision and high cadence over long time periods. In this work, we detail changes to the MINERVA facility that have occurred since our previous paper. We then describe MINERVA's robotic control software, the process by which we perform 1D spectral extraction, and our forward modeling Doppler pipeline. In the process of improving our forward modeling procedure, we found that our spectrograph's intrinsic instrumental profile is stable for at least nine months. Because of that, we characterized our instrumental profile with a time-independent, cubic spline function based on the profile in the cross dispersion direction, with which we achieved a radial velocity precision similar to using a conventional "sum-of-Gaussians" instrumental profile: 1.8 m s$^{-1}$ over 1.5 months on the RV standard star HD 122064. Therefore, we conclude that the instrumental profile need not be perfectly accurate as long as it is stable. In addition, we observed 51 Peg and our results are consistent with the literature, confirming our spectrograph and Doppler pipeline are producing accurate and precise radial velocities., Comment: 22 pages, 9 figures, submitted to PASP, Peer-Reviewed and Accepted

We examined perception of artificial timbre blending using recordings of two actual instruments. In Experiment 1, participants heard stimuli comprising different proportions of sounds from an oboe and a trumpet, constructed using both a linear and a logarithmic algorithm, and judged the degree of blending. In Experiment 2, participants chose between an oboe and a trumpet in each blend condition. In both experiments, participants were able to track the degrees of blending between the two anchor points quite accurately. In Experiment 3, participants matched test blends to two target blends in an ABX design and showed no evidence for categorical perception of oboe and trumpet timbres in their judgments. Further, participants with and without musical training showed similar patterns of responding. The findings suggest a high level of sensitivity for timbre coding in auditory perception and also have implications for timbre manipulation as a compositional device and sound morphing techniques.

In summary, the SGR continues to hang like Damocles sword over physicians. To understand health care needs, we need to separate basic health care needs from economic mandates, and health insurance from health care coverage. The SGR flux represents another meaningful uncertainty to this health care conundrum.

Background: The rapid increase in the prevalence of chronic pain and disability, and the explosion of interventional pain management associated health care costs are a major concern for our community. Further, the increasing utilization of numerous modalities of treatments in managing chronic pain, continue to escalate at a pace which may not be sustainable. There are multiple regulations in place to control the growth of health care expenditures which seem to have been largely ineffective. Among the various modalities utilized in managing chronic pain, interventional techniques have shown a significant increase in their utilization in the face of continued debate with respect to the accuracy of diagnostic interventions and the efficacy of therapeutic interventions. Objective: To update and assess the utilization of interventional techniques in chronic pain management in fee-for-service Medicare population. Study Design: An updated analysis of the growth of interventional techniques in managing chronic pain in fee-for-service Medicare beneficiaries from 2000 through 2013. Methods: The data were derived and analyzed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master Data from 2000 through 2013. Results: From 2000 through 2013, in fee-for-service Medicare beneficiaries, the overall utilization of interventional techniques services increased 236% at an annual average growth of 9.8%, whereas the per 100,000 Medicare population utilization increased 156% with an annual average growth of 7.5%. During this period, the US population increased 12% with an annual average increase of 0.9%, whereas those above 65 years of age increased 27% with an annual average increase of 1.9%. Total Medicare beneficiaries increased 31% with an annual average increase of 2.1%, with an overall increase of 64% for those above 65 years of age, an increase of 26%, constituting 17% of the US population in 2013. The overall increases in epidural and adhesiolysis procedures were 165% compared to 102% per 100,000 fee-for-service population with annual average increases of 7.8% and 5.6%. Facet joint and sacroiliac joint injections increased 417% for services with an annual average increase of 13.5%, whereas the rate per 100,000 fee-for-service Medicare beneficiaries increased 295% with an annual average increase of 11.1%. Limitations: Limitations of this assessment include the lack of inclusion of participants from Medicare Advantage plans, lack of appropriate available data for state-wide utilization, and potential errors in documentation, coding, and billing. Conclusion: This update once again shows a significant increase in interventional techniques in feefor-service Medicare beneficiaries from 2000 through 2013 with an increase of 156% per 100,000 Medicare population with an annual average increase of 7.5%. During this period the Medicare population increased 31% with an annual average increase of 2.1%. Key words: Chronic pain, chronic spinal pain, interventional pain management, interventional techniques, epidural injections, facet joint interventions, sacroiliac joint injections

While it appears to be beneficial to apply a detailed disease classification system, the costs, cash flow disruptions, and increased investments with physician time incorporated into learning these processes, patient care might unfortunately suffer. This is essentially an unfunded mandate with much of the burden of transitioning to ICD-10 falling on health care providers,especially small independent practices. This will impact interventional pain management practices substantially.Further, as we have shown in previous manuscripts,the so-called advantages of multiple codes with specificity and granularity does not translate into reality where some specificity is actually lost for various codes. As Grimsley and O'Shea (1) have described in clinical practices, doctors do not treat codes, but they treat patients according to the individual clinical condition.A doctor will be losing valuable time and also will not be able to obtain meaningful information due to burdensome regulations of meaningful use, PQRS,value-based reimbursement, electronic prescribing,and now a major impact with change to ICD-10. Thus,very little benefit will be seen by practitioners, which cannot be said for the health care information industry.With overwhelming regulatory atmosphere created by numerous federal regulations and those including under the Affordable Care Act (15), there is no evidence that ICD-10 is needed, there is no evidence that it will be effective, and, finally, there is preponderance of evidence of adverse consequences. Thus, Congress should be cautious in imposing further regulations on already strained independent practices with ongoing regulations and imposing yet another unfunded mandate on the medical profession.

Chronic neck pain with or without upper extremity pain or headaches is relatively common in the adult population secondary to disc herniation, discogenic pain, spinal stenosis, spondylosis, and post-surgery syndrome. Treatments for chronic neck pain, recalcitrant to conservative management resulting in disability, include surgical management as well as interventional techniques with epidural injections utilizing either an interlaminar approach or transforaminal approach. Even though there have been multiple systematic reviews and randomized clinical trials of efficacy of cervical interlaminar epidural injections, the literature is sparse in reference to cervical transforaminal epidural injections. In addition, cervical transforaminal epidural injections have been associated with an inordinate risk.

Lumbar epidural injections are administered by accessing the epidural space either by caudal, interlaminar, or transforaminal approaches. Epidural injections are administered to manage chronic low back pain with or without lower extremity pain secondary to disc herniation, discogenic pain without facet joint pain, spinal stenosis, post-lumbar surgery syndrome, and degenerative disc disease.

Managing antithrombotic and antiplatelet therapy is one of the common issues while performing interventional techniques to balance the bleeding risk and perioperative risk of thrombosis. There are myriad procedural guidelines on managing anticoagulant and antithrombotic therapy, even though most are not based on appropriate evidence.

The prevalence of mid- and upper back chronic pain is significantly lower than low back and neck pain with reports showing pain of thoracic origin in 5–15% of the patients, compared to 24–44% with neck pain and 33–56% with low back pain. Thoracic intervertebral discs, nerve roots, and facet joints are capable of transmitting pain in the thoracic spine with radiation into the chest wall and abdominal wall. Chronic, persistent thoracic and chest wall pain and radicular pain may be secondary to disc herniation, discogenic pain, spinal stenosis, or post-thoracic surgery syndrome.

Cervical facet, or zygapophysial, joints have been shown to be a source of pain in the neck and referred pain in the head and upper extremities. Cervical facet joints were recognized as a potential source for neck pain in 1977. Based on controlled diagnostic blocks, the prevalence of persistent neck pain secondary to the involvement of cervical facet joints has been established as varying from 36% to 67%. Cervical facet joint pain has been managed with intra-articular injections, facet joint nerve blocks, and/or radiofrequency neurotomy.

Lumbar facet joints were recognized as potential sources of back pain by Goldthwait as early as 1911. The prevalence of persistent low back pain secondary to the involvement of lumbosacral facet joints has been established as varying from 16% to 41% depending on the type of population and setting studied. Lumbar facet joint pain has been managed utilizing intra-articular injections, facet joint nerve blocks, or radiofrequency neurotomy. Facet joint radiofrequency denervation for the treatment of lumbar facet joint pain was first described by Shealy, and intra-articular injections and facet joint nerve blocks evolved from diagnostic to prognostic to therapeutic modalities.

The courses of the C8 and thoracic medial branch nerves are described in the introduction of Chapter 22 and demonstrated in Chapter 22D. A thoracic medial branch nerve radiofrequency (RF) neurolysis is indicated for the treatment of axial thoracic (i.e., midback) pain that typically originates from zygapophysial (i.e., facet) joint sprains, contusions, or osteoarthritis. This procedure is performed via a posterior approach. The RF electrode tip is placed at the superolateral edge of the transverse process in an oblique manner so that the tip bisects the superolateral edge.

Pain in the mid back and upper back secondary to facet joints has been shown to be present in 34–48% of patients with chronic thoracic pain. Chronic thoracic facet joint pain is generally treated with either facet joint nerve blocks or radiofrequency neurotomy.

Background: Epidural injections are performed utilizing 3 approaches in the lumbar spine: caudal, interlaminar, and transforaminal. The literature on the efficacy of epidural injections has been sporadic. There are few high-quality randomized trials performed under fluoroscopy in managing disc herniation that have a long-term follow-up and appropriate outcome parameters. There is also a lack of literature comparing the efficacy of these 3 approaches. Methods: This manuscript analyzes data from 3 randomized controlled trials that assessed a total of 360 patients with lumbar disc herniation. There were 120 patients per trial either receiving local anesthetic alone (60 patients) or local anesthetic with steroids (60 patients). Results: Analysis showed similar efficacy for caudal, interlaminar, and transforaminal approaches in managing chronic pain and disability from disc herniation. The analysis of caudal epidural injections showed the potential superiority of steroids compared with local anesthetic alone a 2-year follow-up, based on the average relief per procedure. In the interlaminar group, results were somewhat superior for pain relief in the steroid group at 6 months and functional status at 12 months. Interlaminar epidurals provided improvement in a significantly higher proportion of patients. The proportion of patients nonresponsive to initial injections was also lower in the group for local anesthetic with steroid in the interlaminar trial. Conclusions: The results of this assessment show significant improvement in patients suffering from chronic lumbar disc herniation with 3 lumbar epidural approaches with local anesthetic alone, or using steroids with long-term follow-up of up to 2 years, in a contemporary interventional pain management setting. (Korean J Pain 2015; 28: 11-21)

Background: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. Outcomes Assessment: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Limitations: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, central spinal stenosis, interlaminar epidural injections, caudal epidural injections, steroids, local anesthetics, placebo, active control

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

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the US, specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro™, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA’s own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the US. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain -- the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future. Key words: Chronic non-cancer pain, Food and Drug Administration, opioids, Zohydro, misuse, tolerance, addiction, dependency, medical necessity

threats for facets, epidurals, and spinal cord stimulation (1); certified registered nurse anesthetists (CRNAs) entering the full arena of interventional pain management (2-4); Center for Disease control supported single-dose vial policy being created without products to reasonably support it (5); Food and Drug Administration (FDA) regulating procedural standards of interventional techniques; Noridian led local coverage determinations (LCDs) prepared by Multi-Specialty Pain Workgroup (MPW) (6-8); threatened cuts of cervical epidural injections and facet joint interventions in Tennessee (9,10); empowered insurers limiting interventional pain management (IPM) services (11); usual sustained growth rate (SGR) cut fiasco (12,13); and finally the Thanksgiving gift of draconian cuts for epidural injections amounting to 33% for cervical epidural when in a facility and 56% when performed in a physicians office, and 19% for lumbar interlaminar epidural injection in a facility setting for physician fee and 49% when performed in a physicians office (14). Thus, CMS determined the work value of highly trained and skilled IPM physicians to be a whopping $42 to assess a patient preoperatively, to perform a high risk procedure of cervical epidural injection, and follow post-operatively for next 24 hours. There were successes to match these challenges. Facet joints are not on a national coverage determination (NCD) list. We provided our opinions to the FDA and they are considering them on performance of interventional procedures; the Government Accountability Office (GAO) has started a study to assess if, in fact, CRNAs are qualified to perform interventional techniques (15,16); creation of a group purchasing organization (GPO) with Henry Schein (17); published evidence-based guidelines for interventional techniques listed on Agency for Healthcare Research and Quality’s (AHRQ) National Guideline Clearinghouse (NGC) website (18); reversal of noncoverage decision on cervical epidurals and facet joint interventions in Tennessee (19,20); continuing negotiations with Cigna with evidence submission signed by 684 physicians (21); progress in negotiations with Noridian to revise LCDs based on evidence and reasonable and medically necessary; and finally with a 3 month fix for proposed 24% SGR cut (22). The above referenced challenges have led some to enter 2014 with lackluster enthusiasm, frustration, and dismay. Issues continue, most importantly draconian cuts proposed by the Centers for Medicare and Medicaid Services (CMS) for lumbar and cervical interlaminar epidural injections CPT 62310 and CPT 62311 with a physician payment of $42 for preoperative assessment, performance of the procedure intraoperatively, and post operative management. It is true a physician’s work is valued at $42 or 1.18 or 1.17 physician relative value units (RVUs) by CMS. A national rate of physician reimbursement is $72.72 when performed for each procedure in a facility setting and $108.90 for cervical epidural and $110.69 for lumbar epidural when performed in an office setting. Using simple arithmetic, the reimbursement has dropped to $36 for Health Policy Opinion

Continuing rise in health care costs in the United States, the Affordable Care Act (ACA), and a multitude of other regulations impact providers in 2013. Despite federal spending slowing in the past 2 years, the Board of Medicare Trustees believes that cost savings are only achievable if health care providers are able to realize productivity improvements at a quicker pace than experienced historically. Consequently, the re-engineering of U.S. health care and bridging of the divide between health and health care have been proposed beyond affordable care. Thus, the Medicare Payment Advisory Commission (MedPAC) envisions alignment of Medicare payment systems to eliminate variable rates for the same ambulatory services provided to similar patients in different settings, such as the physician’s office, hospital outpatient departments (HOPDs), and ambulatory surgery centers (ASCs). MedPAC believes that if the same service can be safely provided in different settings, a prudent purchaser should not pay more for that service in one setting than in another. MedPAC is also concerned that payment variations across settings encourage arrangements among providers that result in care being provided in high paid settings. MedPAC recommends that payment rates be based on the resources needed to treat patients in the most efficient setting, adjusting for differences in patient severity, to the extent the severity differences affect costs. MedPAC has analyzed the costs of evaluation and management (E&M) services and the differences between providing them in a HOPD setting compared to a physician office setting, echocardiography services, and multiple services provided in ASCs and HOPDs. MedPAC has shown that for an established patient office visit (CPT 99213) provided in a free-standing physician’s office, the program pays the physician 70% less than in HOPD setting with a payment for physician practice of $72.50 versus $123.38 for HOPD setting. Similarly, for a Level II echocardiogram, HOPD costs 141% more for the same service than a free-standing office ($188.31 versus $452.89). For interventional techniques, Medicare payments vary from physician office to HOPD setting, with $211.96 in an office setting, $407.28 in ASC setting, and $655.62 in HOPD for procedures such as epidural injections. The MedPAC proposal for changing HOPD payment rates for services would reduce program spending and result in beneficiary cost sharing by $900 million in one year. On average, hospitals’ overall Medicare revenue will decline by 0.6% and HOPD revenue would fall by 2.7%. Further, MedPAC provided a specific example that aligning payment rates between HOPDs and freestanding offices only for cardiac imaging services would reduce program spending and beneficiary cost sharing by $500 million in one year. In estimating the savings that would be realized by equalizing payment rates between HOPDs and ASCs for certain ambulatory surgical procedures, MedPAC have shown potential Medicare program spending and beneficiary cost savings to be about $590 million per year. The impact of the proposed policies that are discussed in this manuscript would result in savings of approximately $1.5 billion per year for Medicare. MedPAC also has recommended a stop-loss policy that would limit the loss of Medicare revenue for those hospitals. Key words: Medicare, health care delivery system, Medicare Payment Advisory Commission (MedPAC), hospital outpatient departments (HOPDs), ambulatory surgery centers (ASCs), physician office practices

Background: In this era of escalating health care costs and the questionable effectiveness of multiple interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine, and has an influence coverage decisions. Even though multiple cost effectiveness analysis studies have been performed over the years, extensive literature is lacking for interventional techniques. Cost utility analysis studies of epidural injections for managing chronic low back pain demonstrated highly variable results including a lack of cost utility in randomized trials and contrasting results in observational studies. There has not been any cost utility analysis studies of epidural injections in large randomized trials performed in interventional pain management settings. Objectives: To assess the cost utility of caudal epidural injections in managing chronic low back pain secondary to lumbar disc herniation, axial or discogenic low back pain, lumbar central spinal stenosis, and lumbar post surgery syndrome. Study Design: This analysis is based on 4 previously published randomized trials. Setting: A private, specialty referral interventional pain management center in the United States. Methods: Four randomized trials were conducted assessing the clinical effectiveness of caudal epidural injections with or without steroids for lumbar disc herniation, lumbar discogenic or axial low back pain, lumbar central spinal stenosis, and post surgery syndrome. A cost utility analysis was performed with direct payment data for a total of 480 patients over a period of 2 years from these 4 trials. Outcome included various measures with significant improvement defined as at least a 50% improvement in pain reduction and disability status. Results: The results of 4 randomized controlled trials of low back pain with 480 patients with a 2 year follow-up with the actual reimbursement data showed cost utility for one year of quality-adjusted life year (QALY) of $2,206 for disc herniation, $2,136 for axial or discogenic pain without disc herniation, $2,155 for central spinal stenosis, and $2,191 for post surgery syndrome. All patients showed significant improvement clinically and showed positive results in the cost utility analysis with an average cost per one year QALY of $2,172.50 for all patients and $1,966.03 for patients judged to be successful. The results of this assessment show a better cost utility or lower cost of managing chronic, intractable low back pain with caudal epidural injections at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, and surgery in most cases. Limitations: The limitations of this cost utility analysis include that it is a single center evaluation, even though 480 patients were included in the analysis. Further, only the costs of interventional procedures and physician visits were included. The benefits of returning to work were not assessed. Conclusion: This cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per one year of QALY. Key words: Caudal epidural injections, chronic low back pain, lumbar disc herniation, lumbar discogenic pain, lumbar spinal stenosis, lumbar post surgery syndrome, cost utility analysis, cost effectiveness analysis, quality-adjusted life years

Background: The intervertebral disc has been implicated as a major cause of chronic lumbar spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients. Lumbar provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature, intense debate continues about lumbar discography as a diagnostic tool. Study Design: A systematic review of the diagnostic accuracy of lumbar provocation and analgesic discography literature. Objective: To systematically assess and re-evaluate the diagnostic accuracy of lumbar discography. Methods: The available literature on lumbar discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. However, studies scoring less than 50% are presented descriptively and critically analyzed. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Results: Over 160 studies were considered for inclusion. Of these, 33 studies compared discography with other diagnostic tests, 30 studies assessed the diagnostic accuracy of discography, 22 studies assessed surgical outcomes for discogenic pain, and 3 studies assessed the prevalence of lumbar discogenic pain. The quality of the overall evidence supporting provocation discography based on the above studies appears to be fair. The prevalence of internal disc disruption is estimated to be 39% to 42%, whereas the prevalence of discogenic pain without assessing internal disc disruption is 26%. Conclusion: This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. Key words: Lumbar intervertebral disc, lumbar discography, provocation discography, analgesic discography, diagnostic accuracy

Background: Lumbosacral selective nerve root blocks and/ or transforaminal epidural injections are used for diagnosis and treatment of different disorders causing low back and lower extremity pain. A clear consensus on the use of selective nerve root injections as a diagnostic tool does not currently exist. Additionally, the validity of this procedure as a diagnostic tool is not clear. Objective: To evaluate and update the accuracy of selective nerve root injections in diagnosing lumbar spinal disorders. Study Design: A systematic review of selective nerve root blocks for the diagnosis of low back and lower extremity pain. Methods: Methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. Studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, or limited or poor based on the quality of evidence grading scale developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: In this review, we evaluated studies in which controlled local anesthetic blocks were performed using at least 50% pain relief as the reference standard. Results: There is limited evidence for the accuracy of selective nerve root injections as a diagnostic tool for lumbosacral disorders. There is limited evidence for their use in the preoperative evaluation of patients with negative or inconclusive imaging studies. Limitations: The limitations of this systematic review include a paucity of literature, variations in technique, and variable criterion standards for the diagnosis of lumbar radicular pain. Conclusions: There is limited evidence for selective nerve root injections as a diagnostic tool in evaluating low back pain with radicular features. However, their role needs to be further clarified by additional research and consensus. Key words: Low back pain, lower extremity pain, selective nerve root block, transforaminal epidural injection, discogenic pain, radiculitis, sciatica radiculopathy, nerve root pain

Background: Post lumbar surgery syndrome refers to pain occurring or present after lumbar surgery. While the causes of pain after lumbar surgery are multi-factorial, scarring is a significant source of that pain. Low back and/or leg pain after lumbar surgery can persist despite appropriate conservative therapy. Spinal endoscopy allows direct visual evaluation of the epidural space, along with mechanical lysis of any adhesions present. Study Design: A systematic review of the effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome. Objective: To evaluate and update the effectiveness of spinal endoscopic adhesiolysis in treating post lumbar surgery syndrome. Methods: The available literature on spinal endoscopic adhesiolysis in treating post lumbar surgery syndrome 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 Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Pain relief and functional improvement were the primary outcome measures. Other outcome measures were improvement of psychological status, opioid intake, and return to work. Short-term effectiveness was defined as improvement of 12 months or less; whereas, long-term effectiveness was defined 12 months or longer. Results: For this systematic review, 21 studies were identified. Of these, one randomized controlled trial (RCT) and 5 observational studies met the inclusion criteria. Two of the observational studies were excluded because of other methodological issues, despite showing positive outcomes. Using current criteria for successful outcomes, these studies indicate that there is fair evidence for the effectiveness of spinal endoscopy in the treatment of persistent low back and/or leg pain in post lumbar surgery syndrome. Limitations: The limitations of this systematic review include the paucity of literature. Conclusion: The evidence is fair that spinal endoscopy is effective in the treatment of post lumbar surgery syndrome. Key words: Spinal pain, chronic low back pain, post lumbar surgery syndrome, epidural scarring, adhesiolysis, endoscopy

Background: Therapeutic lumbar facet joint interventions are implemented to provide long-term pain relief after the facet joint has been identified as the basis for low back pain. The therapeutic lumbar facet joint interventions generally used for the treatment of low back pain of facet joint origin are intraarticular facet joint injections, lumbar facet joint nerve blocks, and radiofrequency neurotomy. Objective: To evaluate and update the effect of therapeutic lumbar facet joint interventions in managing chronic low back pain. Study Design: A systematic review of therapeutic lumbar facet joint interventions for the treatment of chronic low back pain. Methods: The available literature on lumbar facet joint interventions in managing chronic low back 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 Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief with short-term relief defined as up to 6 months and long-term relief as 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: For this systematic review, 122 studies were identified. Of these, 11 randomized trials and 14 observational studies met inclusion criteria for methodological quality assessment. The evidence for radiofrequency neurotomy is good and fair to good for lumbar facet joint nerve blocks for short- and long-term improvement; whereas the evidence for intraarticular injections and pulsed radiofrequency neurotomy is limited. Limitations: The limitations of this systematic review include the continued paucity of evidence, specifically for intraarticular injection therapy. Conclusion: In summary, there is good evidence for the use of conventional radiofrequency neurotomy, and fair to good evidence for lumbar facet joint nerve blocks for the treatment of chronic lumbar facet joint pain resulting in short-term and long-term pain relief and functional improvement. There is limited evidence for intraarticular facet joint injections and pulsed radiofrequency thermoneurolysis. Key Words: Spinal pain, chronic low back pain, lumbar intraarticular facet joint blocks, lumbar facet joint nerve blocks, lumbar conventional radiofrequency neurotomy, pulsed radiofrequency neurolysis

Background: The prevalence of chronic, recurrent neck pain is approximately 15% of the adult general population. Controlled studies have supported the existence of cervical facet or zygapophysial joint pain in 36% to 67% of these patients, when disc herniation, radiculitis, and discogenic are not pathognomic. However, these studies also have shown false-positive results in 27% to 63% of the patients with a single diagnostic block. There is also a paucity of literature investigating therapeutic interventions of cervical facet joint pain. Study Design: Systematic review of therapeutic cervical facet joint interventions. Objective: To determine and update the clinical utility of therapeutic cervical facet joint interventions in the management of chronic neck pain. Methods: The available literature for utility of facet joint interventions in therapeutic management of cervical facet joint 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 Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, 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. Results: In this systematic review, 32 manuscripts were considered for inclusion. For final analysis, 4 randomized trials and 6 observational studies met the inclusion criteria and were included in the evidence synthesis. Based on one randomized, sham-controlled, double-blind trial and 5 observational studies, the indicated evidence for cervical radiofrequency neurotomy is fair. Based on one randomized, double-blind, active-controlled trial and one prospective evaluation, the indicated evidence for cervical medial branch blocks is fair. Based on 2 randomized controlled trials, the evidence for cervical intraarticular injections is limited. Limitations: Paucity of the overall published literature and specifically lack of literature for intraarticular cervical facet joint injections. Conclusions: The indicated evidence for cervical radiofrequency neurotomy is fair. The indicated evidence for cervical medial branch blocks is fair. The indicated evidence for cervical intraarticular injections with local anesthetic and steroids is limited. Key words: Chronic neck pain, cervical facet or zygapophysial joint pain, cervical medial branch blocks, cervical radiofrequency neurotomy, cervical intraarticular facet joint injections

Background: Lumbar facet joints are a well recognized source of low back pain and referred pain in the lower extremity in patients with chronic low back pain. Conventional clinical features and other non-invasive diagnostic modalities are unreliable in diagnosing lumbar zygapophysial joint pain. Controlled diagnostic studies with at least 80% pain relief as the criterion standard have shown the prevalence of lumbar facet joint pain to be 16% to 41% of patients with chronic low back pain without disc displacement or radiculitis, with a false-positive rate of 17% to 49% with a single diagnostic block. Study Design: A systematic review of the diagnostic accuracy of lumbar facet joint nerve blocks. Objective: To determine and update the diagnostic accuracy of lumbar facet joint nerve blocks in the assessment of chronic low back 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. Studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Studies must have been performed utilizing controlled local anesthetic blocks. Pain relief was categorized as at least 50% pain relief from baseline pain and the ability to perform previously painful movements. Results: A total of 25 diagnostic accuracy studies were included. Of these, one study evaluated 50% to 74% relief as criterion standard with a single block with prevalence of 48%, 4 studies evaluated 75% to 100% relief as the criterion standard with a single block with a prevalence of 31% to 61%, 5 studies evaluated 50% to 74% relief as the criterion standard with controlled blocks with a prevalence of 15% to 61%, and 13 studies evaluated 75% to 100% relief as the criterion standard with controlled blocks with a prevalence of 25% to 45% in heterogenous populations. False-positive rates ranged from 17% to 66% in the 50% to 74% pain relief group and 27% to 49% with at least 75% relief as the criterion standard. Based on this evaluation, the evidence showed that there is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks and fair evidence with 50% to 74% pain relief as the criterion standard with controlled diagnostic blocks; however, the evidence is poor with single diagnostic blocks of 50% to 74%, and limited for 75% or more pain relief as the criterion standard. Limitations: The shortcomings of this systematic review of the accuracy of diagnostic lumbar facet joint nerve blocks include a paucity of literature and continued debate on an appropriate gold standard. Conclusion: There is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks, with fair evidence with 50% to 74% pain relief. Key words: Chronic low back pain, lumbar facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks

Background: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with a prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatment are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Controlled studies have supported the existence of cervical facet or zygapophysial joint pain in 36% to 60% in heterogenous population of these patients. However, these studies also have shown false-positive results in 27% to 63% of patients with a single diagnostic block. Study Design: A systematic review of diagnostic cervical facet joint nerve blocks. Objective: To evaluate and update the accuracy of diagnostic facet joint nerve blocks in the diagnosis of facet joint 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. Studies scoring less than 50% are presented descriptively and critically analyzed. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Results: Overall, a total of 26 manuscripts were considered for diagnostic accuracy evaluation and 9 manuscripts for studies evaluating various factors influencing the diagnostic validity of facet joint interventions. Based on 9 studies meeting the inclusion criteria utilizing 75% to 100% pain relief as the criterion standard with controlled blocks, the evidence is good for diagnostic accuracy of cervical facet joint pain, with a prevalence of 36% to 60% with a false-positive rate of 27% to 63% with a single block. Based on 2 studies from the same group of authors, the evidence for 75% to 100% pain relief as the criterion standard with a single block is limited. The evidence is limited for a single diagnostic block with 50% to 74% pain relief as the criterion standard, whereas no studies were available assessing the accuracy of 50% to 74% pain relief as the criterion standard with controlled blocks. Limitations: The limitations of this systematic review include a paucity of literature on outcomes, randomized, placebo-controlled trials and a lack of consensus on a gold standard. Conclusions: Diagnostic cervical facet joint nerve blocks are safe, valid, and reliable. The strength of evidence for diagnostic facet joint nerve blocks is good with the utilization of controlled diagnostic blocks with at least 75% pain relief as the criterion standard; however, the evidence is limited for single blocks or dual blocks for relief of 50% to 74% and single blocks with at least 75% pain relief. Key words: Chronic neck pain, cervical facet or zygapophysial joint pain, cervical medial branch blocks, controlled comparative local anesthetic blocks

Background Chronic neck pain represents a significant public health problem. Despite high prevalence rates, there is a lack of consensus regarding the causes or treatments for this condition. Based on controlled evaluations, the cervical intervertebral discs, facet joints, and atlantoaxial joints have all been implicated as pain generators. Cervical provocation discography, which includes disc stimulation and morphological evaluation, is occasionally used to distinguish a painful disc from other potential sources of pain. Yet in the absence of validation and controlled outcome studies, the procedure remains mired in controversy. Study design A systematic review of the diagnostic accuracy of cervical discography. Objective To systematically evaluate and update the diagnostic accuracy of cervical discography. Methods The available literature on cervical discography was reviewed. 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. However, studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Results A total of 41 manuscripts were considered for accuracy and utility of cervical discography in chronic neck pain. There were 23 studies evaluating accuracy of discography. There were 3 studies meeting inclusion criteria for assessing the accuracy and prevalence of discography, with a prevalence of 16% to 53%. Based on modified Agency for Healthcare Research and Quality (AHRQ) accuracy evaluation and United States Preventive Services Task Force (USPSTF) level of evidence criteria, this systematic review indicates the strength of evidence is limited for the diagnostic accuracy of cervical discography. Limitations Limitations include a paucity of literature, poor methodological quality, and very few studies performed utilizing International Association for the Study of Pain (IASP) criteria. Conclusion There is limited evidence for the diagnostic accuracy of cervical discography. Nevertheless, in the absence of any other means to establish a relationship between pathology and symptoms, cervical provocation discography may be an important evaluation tool in certain contexts to identify a subset of patients with chronic neck pain secondary to intervertebral disc disorders. Based on the current systematic review, cervical provocation discography performed according to the IASP criteria with control disc(s), and a minimum provoked pain intensity of 7 of 10, or at least 70% reproduction of worst pain (i.e. worst spontaneous pain of 7 = 7 x 70% = 5), may be a useful tool for evaluating chronic pain and cervical disc abnormalities in a small proportion of patients.

Background: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatments are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. 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. Study Design: A systematic review of cervical interlaminar epidural injections for cervical disc herniation, cervical axial discogenic pain, cervical central stenosis, and cervical postsurgery syndrome. 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 on cervical interlaminar epidural injections in managing chronic neck and upper extremity pain were 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 Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, 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. Results: For this systematic review, 34 studies were identified. Of these, 24 studies were excluded and a total of 9 randomized trials, with 2 duplicate studies, met inclusion criteria for methodological quality assessment. For cervical disc herniation, the evidence is good for cervical epidural with local anesthetic and steroids; whereas, it is fair with local anesthetic only. For axial or discogenic pain, the evidence is fair for local anesthetic, with or without steroids. For spinal stenosis, the evidence is fair for local anesthetic, with or without steroids. For postsurgery syndrome, the evidence is fair for local anesthetic, with or without steroids. Limitations: The limitations of this systematic review continue to be the paucity of literature. Conclusion: The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas, it is fair for local anesthetics with or without steroids, for axial or discogenic pain, pain of central spinal stenosis, and pain of post surgery syndrome. Key words: Cervical disc herniation, cervical axial discogenic pain, cervical central spinal stenosis, cervical post surgery syndrome, cervical radiculitis, cervical interlaminar epidural injections, local anesthetic, steroids

Guideline development seems to have lost some of its grounding as a medical science. At their best, guidelines should be a constructive response to assist practicing physicians in applying the exponentially expanding body of medical knowledge. In fact, guideline development seems to be evolving into a cottage industry with multiple, frequently discordant guidance on the same subject. Evidence Based Medicine does not always provide for conclusive opinions. With competing interests of payers, practitioners, health policy makers, and third parties benefiting from development of the guidelines as cost saving measures, guideline preparation has been described as based on pre-possession, vagary, rationalization, or congeniality of conclusion. Beyond legitimate differences in opinions regarding the evidence that could yield different guidelines there are potentials for conflicts of interest and various other issues play a major role in guideline development. As is always the case, conflicts of interest in guideline preparation must be evaluated and considered. Following the development of American Pain Society (APS) guidelines there has been an uproar in interventional pain management communities on various issues related to not only the evidence synthesis, but conflicts of interest. A recent manuscript published by Chou et al, in addition to previous publications appear to have limited clinician involvement in the development of APS guidelines, demonstrates some of these challenges clearly. This manuscript illustrates the deficiencies of Chou et al’s criticisms, and demonstrates their significant conflicts of interest, and use a lack of appropriate evaluations in interventional pain management as a straw man to support their argument. Further, this review will attempt to demonstrate that excessive focus on this straw man has inhibited critique of what we believe to be flaws in the approach. Key words: Guidelines, interventional pain management, professionalism, discourse, disclosure, conflicts of interest, evidence-based medicine, comparative effectiveness research, Patient-Centered Outcomes Research Institute

Background: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. Study Design: A randomized, double-blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objective: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. Methods: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. Outcomes Assessment: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of ≥ 50% was considered significant. Results: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I’s significant pain relief was 70%; Group II’s was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group. Limitations: The lack of a placebo group and preliminary results are limitations. Conclusion: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, lumbar spinal stenosis, central stenosis, lumbar interlaminar epidural injections, epidural steroids, local anesthetic.

The International Classification of Diseases-10 (ICD-10) is a new system that is a federally mandated change affecting all payers and providers, and is expected to exceed both the Health Insurance Portability and Accountability Act (HIPAA) and Y2K in terms of costs and risks. In 2003, HIPAA named ICD-9 as the code set for supporting diagnoses and procedures in electronic administrative transactions. However, on 16 January 2009, the Department of Health and Human Services published a regulation requiring the replacement of ICD-9 with ICD-10 as of 1 October 2013. While ICD-9 and ICD-10 have a similar type of hierarchy in their structures, ICD-10 is more complex and incorporates numerous changes. Overall, ICD-10 contains more than 141 000 codes, a whopping 712% increase over the

The International Classification of Diseases-10 (ICD-10 is a new system that is expected to be implemented effective on October 1, 2013. This new system is a federally mandated change affecting all payers and providers, and is expected to exceed both the Health Insurance Portability and Accountability Act (HIPAA) and Y2K in terms of costs and risks. However, the Administration is poised to implement these changes at a rapid pace which could be problematic for health care in the United States. In 2003, HIPAA named ICD-9 as the code set for supporting diagnoses and procedures in electronic administrative transactions. However, on January 16, 2009, the Department of Health and Human Services (HHS) published a regulation requiring the replacement of ICD9 with ICD-10 as of October 1, 2013. While ICD-9 and 10 have a similar type of hierarchy in their structures, the ICD-10 is more complex and incorporates numerous changes. Overall, ICD-10 contains over 141,000 codes, a whopping 712% increase over the less than 20,000 codes in ICD-9, creating enormous complexities, confusion, and expense. Multiple published statistics illustrate that there are approximately 119 instances where a single ICD-9 code can map to more than 100 distinct ICD-10 codes, whereas there are 255 instances where a single ICD-9 code can map to more than 50 ICD-10 codes. To add to the confusion, there are 3,684 instances in the mapping for diseases where a single ICD-10 code can map to more than one ICD-9 code. Proponents of the new ICD-10 system argue that the granularity should lead to improvements in the quality of health care, since more precise coding that more accurately reflects actual patient conditions will permit smarter and more effective disease management in pay-forperformance programs. This, in essence, encapsulates the benefits that supporters of this new system believe will be realized, even though many of these experts may not be involved in actual day-to-day medical practices. Detractors of the system see the same granularity as burdensome. The estimated cost per physician is projected to range from $25,000 to $50,000. Further, they argue that the ICD10 classification is extremely complicated, and expensive. Concerns exist that it is being implemented without establishing either the necessity or thinking through the unintended consequences. Opponents also argue that beyond financial expense, it is also costly in terms of human toll, hardware and software expenses and has the potential to delay reimbursement. There is also concern that an unintended consequence of granularity would be the potential for enhanced and unnecessary fraud and abuse investigations. The authors of this article favor postponing the implementation of the ICD-10 until such time as its necessity is proven and implications are understood. Key words: Diagnostic coding systems, International Statistical Classification of Diseases and Related Health Problems (ICD), ICD-9-CM, ICD-10-CM, regulations, growth, evidencebased literature, reimbursement, claims, Health Insurance Portability and Accountability Act (HIPAA)

The Independent Payment Advisory Board (IPAB) is a vastly powerful component of the president’s health care reform law, with authority to issue recommendations to reduce the growth in Medicare spending, providing recommendations to be considered by Congress and implemented by the administration on a fast track basis. Ever since its inception, IPAB has been one of the most controversial issues of the Patient Protection and Affordable Care Act (ACA), even though the powers of IPAB are restricted and multiple sectors of health care have been protected in the law. IPAB works by recommending policies to Congress to help Medicare provide better care at a lower cost, which would include ideas on coordinating care, getting rid of waste in the system, providing incentives for best practices, and prioritizing primary care. Congress then has the power to accept or reject these recommendations. However, Congress faces extreme limitations, either to enact policies that achieve equivalent savings, or let the Secretary of Health and Human Services (HHS) follow IPAB’s recommendations. IPAB has strong supporters and opponents, leading to arguments in favor of or against to the extreme of introducing legislation to repeal IPAB. The origins of IPAB are found in the ideology of the National Institute for Health and Clinical Excellence (NICE) and the impetus of exploring health care costs, even though IPAB’s authority seems to be limited to Medicare only. The structure and operation of IPAB differs from the Medicare Payment Advisory Commission (MedPAC) and has been called “MedPAC on steroids”. The board membership consists of 15 full-time members appointed by the president and confirmed by the Senate with options for recess appointments. The IPAB statute sets target growth rates for Medicare spending. The applicable percent for maximum savings appears to be 0.5% for year 2015, 1% for 2016, 1.25% for 2017, and 1.5% for 2018 and later. The IPAB Medicare proposal process involves mandatory recommendations and advisory recommendations with multiple reporting requirements. However, although IPAB has been described as having limited authority, some believe that it has unlimited authority due to the lack of judicial review and the requirement of twothirds of the Congress to override any recommendations by IPAB. Key Words: Independent Payment Advisory Board (IPAB), Patient-Centered Outcomes Research Institute (PCORI), Congressional Budget Office (CBO), National Institute for Health and Clinical Excellence (NICE), Patient Protection and Affordable Care Act (ACA), interventional pain management, interventional techniques.

Background: The prevalence of cancer-related pain and residual pain in cancer survivors is high. Opioids serve as the gold standard for treating moderate to severe cancer pain. The evaluation of the effectiveness of opioids in chronic non-cancer pain has shown a lack of effectiveness, or rather weak evidence for some of the drugs. In contrast, in cancer pain, opioids are expected to be very effective. Due to the nature of the disease, there is evidence of a paucity of randomized trials investigating opioid effectiveness in cancer pain on a long-term basis. Consequently, the effectiveness of opioids in managing cancer-related pain warrants further evidence-based review beyond randomized trials, including observational studies and case reports. Methods: The comprehensive literature search was conducted for the period 1996 through June 2010. Databases for the search included PubMed, EMBASE, Cochrane Reviews, and clinicaltrails.gov, along with reviews and cross references. Methodologic quality assessment of the observational studies managing chronic cancer pain with opioids was conducted utilizing the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. Analysis of evidence included 5 levels of evidence developed by the United States Preventive Services Task Force (USPSTF) ranging from Level I to III with 3 subcategories in Level II. Grading recommendations were based on Guyatt et al’s recommendations with 6 levels: 3 in the strong category and 3 in the weak category. Results: This evaluation is of 18 manuscripts considered for inclusion; 7 manuscripts met the inclusion criteria based on AHRQ quality assessment. Level of evidence for opioid therapy in cancer pain was Level II-3, and recommendations were 1C/strong recommendation based on observational studies, which could change based on future evidence. Conclusion: This systematic review of observational studies indicates Level II3 evidence for effectiveness of opioids in cancer pain therapy, with 1C/strong recommendation based on observational studies, which could change based on future evidence. Key words: Chronic pain, cancer pain, non-cancer pain, randomized trials, observational studies, case reports, opioids, effectiveness

Background: Thoracic facet joints have been implicated as the source of chronic pain in the mid back or upper back in 34% to 42% of patients when the modified criteria of the International Association for the Study of Pain (IASP) is utilized. Various therapeutic techniques utilized in managing chronic thoracic pain of facet joint origin include intraarticular injections, medial branch blocks, and radiofrequency neurotomy of thoracic medial branch nerves. Study Design: A randomized, double-blind, active controlled trial. Setting: A private practice, interventional pain management setting, and a specialty referral center setting in the United States. Objective: To determine the clinical effectiveness of therapeutic local anesthetic medial branch blocks with or without steroid in managing chronic function-limiting mid back or upper back pain of facet joint origin. Methods: The study was performed in an interventional pain management private practice, a tertiary referral center, in the United States. A total of 100 participants were included, with 50 participants in each of the local anesthetic and steroid groups. All of the participants met the diagnostic criteria of thoracic facet joint pain by means of comparative, controlled diagnostic blocks and the inclusion criteria. Group I participants received thoracic medial branch blocks with bupivacaine, whereas Group II participants received thoracic medial branch blocks with bupivacaine and non-particulate betamethasone. Outcomes Assessment: Outcomes measures included numeric rating scores (NRS), Oswestry Disability Index (ODI), opioid intake, and return to work status at baseline, 3 months, 6 months, and 12 months. Significant pain relief was defined as ≥ 50% pain relief and/or a positive change in ODI scores. Results: In Group I and Group II 90% of participants showed significant pain relief and functional improvement at 12 months. The majority of the participants experienced significant pain relief of 47.2 ± 10.1 weeks in Group I and 46.3 ± 8.4 weeks in Group II, requiring approximately 3.5 treatments per year with an average relief of 15.8 ± 10.5 in Group I and 13.6 ± 3.6 weeks in Group II per episode of treatment. Limitations: Study limitations include the lack of a placebo group. Conclusions: Therapeutic thoracic medial branch blocks, with or without steroid, may provide a management option for chronic function-limiting mid back or upper back pain of facet joint origin. Clinical Trial: NCT00355706 Key words: Chronic spinal pain, thoracic pain, thoracic facet or zygapophysial joint pain, facet joint nerve or medial branch blocks, comparative controlled local anesthetic blocks, therapeutic thoracic medial branch blocks.