Publications by authors named "Frank J E Falco"

102 Publications

Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials.

Surg Neurol Int 2015 7;6(Suppl 4):S194-235. Epub 2015 May 7.

Vice Chief of Interventional Care, Chief of Minimally Invasive Spine Surgery, Service Line Chief of Interventional Radiology, Director of Endovascular Neurosurgery and Neuroendovascular Program, Massachusetts General Hospital; and Associate Professor, Department of Radiology, Harvard Medical School, Boston, MA, USA.

Background: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with long-term follow-ups.

Methods: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV).

Results: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple high-quality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone.

Conclusion: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone.
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http://dx.doi.org/10.4103/2152-7806.156598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431057PMC
May 2015

Safeguards to prevent neurologic complications after epidural steroid injections: analysis of evidence and lack of applicability of controversial policies.

Pain Physician 2015 Mar-Apr;18(2):E129-38

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; and Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA.

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October 2015

An updated assessment of utilization of interventional pain management techniques in the Medicare population: 2000 - 2013.

Pain Physician 2015 Mar-Apr;18(2):E115-27

Pain Management Center of Paducah, Paducah, KY; and University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA.

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 fee-for-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%.
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October 2015

First, do no harm by adopting evidence-based policy initiatives: the overselling of ICD-10 by congress with high expectations.

Pain Physician 2015 Mar-Apr;18(2):E107-13

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA.

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.
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October 2015

Elusive "Doc Fix": Groundhog Day 2015 for sustainable growth rate (SGR).

Pain Physician 2015 Mar-Apr;18(2):E101-5

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA; Spine Pain Diagnostics Associates, Niagara, WI; and Massachus.

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.
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October 2015

A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up.

Pain Physician 2015 Jan-Feb;18(1):79-92

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY, and Mid Atlantic Spine & Pain Physicians of Newark, Newark, DE.

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.

Clinical Trial: NCT00681447.
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November 2015

Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review.

Pain Physician 2015 Jan-Feb;18(1):39-60

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; New York University School of Medicine, New York, NY.

Background: The high prevalence of chronic persistent neck pain not only leads to disability but also has a significant economic, societal, and health impact. Among multiple modalities of treatments prescribed in the management of neck and upper extremity pain, surgical, interventional and conservative modalities have been described. Cervical epidural injections are also common modalities of treatments provided in managing neck and upper extremity pain. They are administered by either an interlaminar approach or transforaminal approach.

Objectives: To determine the long-term efficacy of cervical interlaminar and transforaminal epidural injections in the treatment of cervical disc herniation, spinal stenosis, discogenic pain without facet joint pain, and post surgery syndrome.

Methods: The literature search was performed from 1966 to October 2014 utilizing data from PubMed, Cochrane Library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references. The evidence was assessed based on best evidence synthesis with Level I to Level V.

Results: There were 7 manuscripts meeting inclusion criteria. Of these, 4 assessed the role of interlaminar epidural injections for managing disc herniation or radiculitis, and 3 assessed these injections for managing central spinal stenosis, discogenic pain without facet joint pain, and post surgery syndrome. There were 4 high quality manuscripts. A qualitative synthesis of evidence showed there is Level II evidence for each etiology category. The evidence is based on one relevant, high quality trial supporting the efficacy of cervical interlaminar epidural injections for each particular etiology. There were no randomized trials available assessing the efficacy of cervical transforaminal epidural injections.

Limitations: Paucity of available literature, specifically conditions other than disc herniation.

Conclusion: This systematic review with qualitative best evidence synthesis shows Level II evidence for the efficacy of cervical interlaminar epidural injections with local anesthetic with or without steroids, based on at least one high-quality relevant randomized control trial in each category for disc herniation, discogenic pain without facet joint pain, central spinal stenosis, and post surgery syndrome.
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November 2015

Lumbar interlaminar epidural injections are superior to caudal epidural injections in managing lumbar central spinal stenosis.

Pain Physician 2014 Nov-Dec;17(6):E691-702

Pain Management Center of Paducah, Paducah, KY, and 2University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA; and Massachusetts General Hospital and Harvard Medical Schoo.

Background: Epidural injections are performed to manage lumbar central spinal stenosis pain utilizing caudal, interlaminar, and transforaminal approaches. The literature on the efficacy of epidural injections in managing lumbar central spinal stenosis pain is sparse; lacking multiple, high quality randomized trials with long-term follow-up.

Methods: Two randomized controlled trials of the caudal and lumbar interlaminar approaches that assessed 220 patients with lumbar central spinal stenosis were analyzed.

Results: The analysis found efficacy for both caudal and interlaminar approaches in managing chronic pain and disability from central spinal stenosis was demonstrated. In the patients responsive to treatment, those with at least 3 weeks of improvement with the first 2 procedures, 51% reported significant improvement with caudal epidural injections, whereas it was 84% with local anesthetic only with interlaminar epidurals, 57% with caudal and 83% with lumbar interlaminar with local anesthetic with steroid. The response rate was 38% with caudal and 72% with lumbar interlaminar with local anesthetic only and 44% with caudal and 73% with lumbar interlaminar with local anesthetic with steroid when all patients were considered. In the interlaminar approach, results were superior for pain relief and functional status with fewer nonresponsive patients compared to the caudal approach.

Limitations: The data was derived from 2 previously published randomized, controlled trials rather than comparing 2 techniques in one randomized controlled trial. Further, the randomized controlled trials were active control trials without a placebo.

Conclusions: The results of this assessment showed significant improvement in patients suffering with chronic lumbar spinal stenosis with caudal and interlaminar epidural approaches with local anesthetic only, or with steroids in a long-term follow-up of up to 2 years, in contemporary interventional pain management setting, with the interlaminar approach providing significantly better results.
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September 2015

Metamorphosis of medicine in the United States: a carrot and stick policy of electronic medical records.

Pain Physician 2014 Nov-Dec;17(6):E671-80

1Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Millennium Pain Center, Bloomington, IL, and University of Illinois, Urbana-Champaign, IL; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple Universi.

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September 2015

Metamorphosis of medicine in the United States: is information technology a white knight or killer whale?

Pain Physician 2014 Nov-Dec;17(6):E663-70

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Millennium Pain Center, Bloomington, IL, and University of Illinois, Urbana-Champaign, IL; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple Universit.

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September 2015

Epidemiology of low back pain in adults.

Neuromodulation 2014 Oct;17 Suppl 2:3-10

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

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.
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http://dx.doi.org/10.1111/ner.12018DOI Listing
October 2014

Epidural steroid injections safety recommendations by the Multi-Society Pain Workgroup (MPW): more regulations without evidence or clarification.

Pain Physician 2014 Sep-Oct;17(5):E575-88

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA; Millennium Pain Center, Bloomington, IL, and University of Il.

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July 2015

Regarding: Udeh BL, et al. The 2-year Cost-effectiveness of 3 Options to Treat Lumbar Spinal Stenosis Patients. Pain Pract 2014 Jan 3 [epub ahead of print].

Pain Pract 2014 Sep 12;14(7):e161-2. Epub 2014 Aug 12.

Minimally Invasive Spine Surgery, Massachusetts General Hospital, Boston, Massachusetts, U.S.A.

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http://dx.doi.org/10.1111/papr.12236DOI Listing
September 2014

Transforaminal epidural injections in chronic lumbar disc herniation: a randomized, double-blind, active-control trial.

Pain Physician 2014 Jul-Aug;17(4):E489-501

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; and Mid Atlantic Spine & Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA.

Background: The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain. There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain, including epidural injections. Epidural injection administration routes include transforaminal, interlaminar, and caudal approaches. The transforaminal approach requires the smallest volume to reach the primary site of pathology. Systematic reviews have yielded highly variable results, but a recent systematic review showed no significant difference among the 3 approaches.

Study Design: A randomized, controlled, double blind, active control trial.

Setting: An interventional pain management practice, a private specialty referral center in the United States.

Objectives: To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis.

Methods: One hundred twenty patients were randomly assigned to 2 groups: Group I received 1.5 mL of 1% preservative-free lidocaine, followed by 0.5 mL of sodium chloride solution. Group II received 1% lidocaine, followed by 3 mg, or 0.5 mL of betamethasone. The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes.

Outcomes Assessment: The primary outcome measure was significant improvement (at least 50%) measured by the average Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake.

Results: At 2 years there was significant improvement in all participants in 65% who received local anesthetic alone and 57% who received local anesthetic and steroid. When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures, significant improvement (at least 50% improvement in pain and function) was seen in 80% in the local anesthetic group and 73% in the local anesthetic with steroid group.

Limitations: Presumed limitations of this evaluation include the lack of a placebo group.

Conclusion: Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up.
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November 2014

Randomized trial of epidural injections for spinal stenosis published in the New England Journal of Medicine: further confusion without clarification.

Pain Physician 2014 Jul-Aug;17(4):E475-88

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

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 high-quality 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.
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November 2014

Epidural steroid warning controversy still dogging FDA.

Pain Physician 2014 Jul-Aug;17(4):E451-74

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

On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. The panel was unable to reach an agreement on 20 proposed items related to technical aspects of performing epidural injections. Subsequently, the FDA issued the above referenced warning and a notice that a panel will be convened in November 2014. This review assesses the inaccuracies of the warning and critically analyzes the available literature. The literature has been assessed in reference to alternate techniques and an understanding of the risk factors when performing transforaminal epidural injections in the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety. The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections . The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence.
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November 2014

Zohydro approval by food and drug administration: controversial or frightening?

Pain Physician 2014 Jul-Aug;17(4):E437-50

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

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., 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 U.S. 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.
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November 2014

Evidence-based guidelines improperly assessed epidural injections.

Spine J 2014 Jun;14(6):1086-7

Massachusetts General Hospital, 55 Blossom St, Gray 241B, Boston, MA 02114, USA.

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http://dx.doi.org/10.1016/j.spinee.2014.01.029DOI Listing
June 2014

A modified approach to grading of evidence.

Pain Physician 2014 May-Jun;17(3):E319-25

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Mid Atlantic Spine and Pain Physicians, Newark, DE, and Temple University Hospital, Philadelphia, PA; Millennium Pain Center, Bloomington, IL.

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June 2015

Development of an interventional pain management specific instrument for methodologic quality assessment of nonrandomized studies of interventional techniques.

Pain Physician 2014 May-Jun;17(3):E291-317

Pain Management Center of Paducah, Paducah, KY and University of Louisville, Louisville, KY; Massachusetts General Hospital and Harvard Medical School, Boston, MA; Texas Tech University Health Sciences Center, Lubbock, TX.

Background: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques.

Objectives: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques.

Methods: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized.

Results: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria.

Limitations: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations.

Conclusion: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.
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June 2015

Assessment of methodologic quality of randomized trials of interventional techniques: development of an interventional pain management specific instrument.

Pain Physician 2014 May-Jun;17(3):E263-90

Pain Management Center of Paducah, Paducah, KY and University of Louisville, Louisville, KY; Massachusetts General Hospital and Harvard Medical School, Boston, MA; Johns Hopkins University School of Medicine, Baltimore, MD.

Background: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques.

Objectives: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques.

Methods: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques.

Results: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment.

Limitations: Limited validity or accuracy assessment of the instrument and the large number of items to be scored.

Conclusion: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques.
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June 2015

Opioid prescribing.

Ann Intern Med 2014 May;160(10):737

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http://dx.doi.org/10.7326/L14-5010DOI Listing
May 2014

Evaluation of effect on nonsteroid epidural injections.

Anesthesiology 2014 May;120(5):1283-4

University of Louisville, Louisville, Kentucky (L.M.).

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http://dx.doi.org/10.1097/ALN.0000000000000198DOI Listing
May 2014

The disastrous but preventable consequences of ICD-10.

Pain Physician 2014 Mar-Apr;17(2):E111-8

Pain Management Center of Paducah, Paducah, KY and University of Louisville, Louisville, KY; Mid Atlantic Spine & Pain Physicians, Newark, DE and Temple University Hospital, Philadelphia, PA; LSU Health Science Center, New Orleans, LA.

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November 2014

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

Clin Orthop Relat Res 2015 Jun;473(6):1940-56

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

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.
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http://dx.doi.org/10.1007/s11999-014-3490-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4419020PMC
June 2015

A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in disc herniation.

Pain Physician 2014 Jan-Feb;17(1):E61-74

Pain Management Center of Paducah, Paducah, KY, and University of Louisville, Louisville, KY; Spine Pain Diagnostics Associates, Niagara, WI; Mid Atlantic Spine & Pain Physicians of Newark, Newark, DE, and Temple University Hospital, Philadelphia, PA.

Background: Among the multiple nonsurgical modalities, epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis. There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up.

Study Design: Randomized, double-blind, active-controlled trial with 2-year follow-up.

Setting: An interventional pain management practice in the United States.

Objective: The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis.

Methods: Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone.

Outcome Measures: The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake.

Results: Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient's failure to respond to local anesthetic alone, may be treated with addition of steroids.

Limitations: The results of the study are limited by the lack of a placebo group.

Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities.
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September 2014

The tragedy of the sustained growth rate formula continues into 2014: is there hope for repeal?

Pain Physician 2014 Jan-Feb;17(1):E21-6

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

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September 2014

Declining value of work of interventional pain physicians.

Pain Physician 2014 Jan-Feb;17(1):E11-9

Pain Management Center of Paducah, Paducah, KY; and University of Louisville, Louisville, KY; Pain Relief Centers, Conover, NC; Millennium Pain Center, Bloomington,IL; Mid Atlantic Spine & Pain Physicians, Newark, DE; LSU Health Science Center,New Orlean.

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September 2014

Opioids in chronic noncancer pain: have we reached a boiling point yet?

Pain Physician 2014 Jan-Feb;17(1):E1-10

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

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September 2014

Cervical radicular pain: the role of interlaminar and transforaminal epidural injections.

Curr Pain Headache Rep 2014 Jan;18(1):389

Pain Management Center of Paducah, 2831 Lone Oak Road, Paducah, KY, 42003, USA,

Chronic neck pain and cervical radicular pain are relatively common in the adult population. Treatment for chronic radicular pain recalcitrant to conservative management includes surgical management as well as interventional techniques with epidural injections utilizing either an interlaminar approach or transforaminal approach. Although there have been multiple systematic reviews and randomized clinical trials of cervical interlaminar epidural injections, the literature is sparse in reference to cervical transforaminal epidural injections. Overall, there is good evidence for the effectiveness of cervical interlaminar epidural injections in managing cervical disc herniation and fair evidence in managing central spinal stenosis and postsurgery syndrome. The evidence is poor, however, for cervical transforaminal epidural injections. Complications with cervical interlaminar epidural injections are rare, but more commonly occur with transforaminal epidural injections and can be fatal. Emerging concepts in pain include further randomized trials; proper placebo design; focus on control design (either active control or placebo control); and appropriate methodologic quality assessment and evidence synthesis.
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http://dx.doi.org/10.1007/s11916-013-0389-9DOI Listing
January 2014
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