Bloomington, IL, United States
Bloomington, IL, United States

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Manchikanti L.,University of Louisville | Benyamin R.M.,Millennium Pain Center | Benyamin R.M.,University of Illinois at Urbana - Champaign
Pain Physician | Year: 2013

Background: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. Although it is responsible for a very small proportion of patients, disc herniation is the primary focus of modalities of treatments. In fact, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain without disc herniation including surgery, intradiscal therapies, and epidural injections. There is, however, continued debate on the effectiveness, indications, and medical necessity of all modalities of treatments in managing axial or discogenic pain in the lumbar spine. Objectives: To assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids. Study Design: A randomized, double-blind, active-controlled trial. Setting: A private practice, specialty referral, interventional pain management practice in the United States. Methods: In this study, a total of 120 patients were randomly allocated to one of 2 groups of 60 patients receiving either local anesthetic alone or local anesthetic with steroids. The primary outcome measure was at least a 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment. Results: Significant pain relief and functional status improvement, defined as a reduction in scores from baseline of at least 50% or more, were observed in 72% of patients receiving local anesthetic alone and 67% of patients receiving local anesthetic with steroids. Opioid intake was reduced from the baseline in each group for 2 years. 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 are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.


Manchikanti L.,University of Louisville | Benyamin R.M.,Millennium Pain Center | Falco F.J.E.,Mid Atlantic Spine and Pain Physicians of Newark | Caraway D.L.,St Marys Pain Relief Center | And 2 more authors.
Pain Physician | Year: 2012

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.


Helm S.,Pacific Coast Pain Management Center | Benyamin R.M.,Millennium Pain Center | Benyamin R.M.,University of Illinois at Urbana - Champaign | Chopra P.,Brown Medical School | And 2 more authors.
Pain Physician | Year: 2012

Background: Low back pain after either post lumbar surgery syndrome or spinal stenosis in the absence of surgery is a vexing problem. Post lumbar surgery syndrome can occur in any age group, while low back and radicular pain from spinal stenosis is a disease of aging. As the population ages, the incidence of symptomatic spinal stenosis will increase. There are currently limited treatment options for either group. Further surgery is not uniformly effective in relieving pain after previous surgery. While therapies are being developed to treat pain due to spinal stenosis, no therapy other than adhesiolysis will treat pain due to scarring. Adhesiolysis was developed as a means of removing epidural scarring leading directly or indirectly to compression, inflammation, swelling, or a decreased nutritional supply of nerve roots. Adhesiolysis utilizes a number of modalities in the effort to break up epidural scarring, including the use of a wirebound catheter for mechanical adhesiolysis, placement of the catheter in the ventro-lateral aspect of the epidural space at the site of the exiting nerve root, and the use of high volumes of injectate, including local anesthetics and saline, either hypertonic or isotonic, along with steroids. Study Design: A systematic review of percutaneous adhesiolysis in the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis. Objective: To evaluate the effectiveness of percutaneous adhesiolysis in the treatment of efractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis. The severity of risks and adverse advents associated with percutaneous adhesiolysis were also evaluated. Methods: The available literature on percutaneous adhesiolysis for the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis 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 of at least 6 months. Secondary outcome measures were improvement in functional status, change in psychological status, return to work, and reduction in opioid use or interventions. Results: For this systematic review, 15 studies were identified and selected for review. Of these, 5 randomized controlled trials and 2 observational studies met the inclusion criteria. Applying the USPSTF criteria, these studies indicate that there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/or leg pain caused by post lumbar surgery syndrome and that there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/ or leg pain caused by spinal stenosis The incidence of complications from percutaneous adhesiolysis is low and the complications are generally minimal and self-limited. The procedure should be considered to be low risk for serious adverse events when performed by well-trained physicians. Limitations: The limitations of this systematic review include the paucity of literature. Conclusion: In summary, there is fair evidence that percutaneous adhesiolysis is effective in relieving low back and/or leg pain due to post lumbar surgery syndrome or spinal stenosis.


Datta S.,Vanderbilt University | Derby R.,Spinal USA | Wolfer L.R.,Spinal USA | Benyamin R.M.,Millennium Pain Center | Hirsch J.A.,Harvard University
Pain Physician | Year: 2010

Background: Clinical guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. The clinical guideline industry has been erupting even faster than innovation in health care, constantly adding unhealthy perspectives with broad and complex mandates to health care interventions. Clinical guidelines are based on evidence-based medicine (EBM) and comparative effectiveness research (CER). Multiple issues related to the development of clinical guidelines are based on conflicts of interest, controversies, and limitations of the guideline process. Recently, the American Pain Society (APS) developed and published multiple guidelines in managing low back pain resulting in multiple publications. However, these guidelines have been questioned regarding their development process, their implementation, and their impact on various specialties. Objectives: To reassess the APS guidelines' evidence synthesis for low back pain diagnostic interventions using the same methodology utilized by the APS authors. The interventions examined were diagnostic techniques for managing low back pain of facet joint origin, discogenic origin, and sacroiliac joint origin. Methods: A literature search by two authors was carried out utilizing appropriate databases from 1966 through July 2008. Methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and the translation into practice recommendations. Results: Our reassessment of Chou et al's evaluation, utilizing Chou et al's criteria, showed good evidence for lumbar facet joint nerve blocks, fair evidence for lumbar provocation discography, and fair to poor evidence for sacroiliac joint blocks to diagnose sacroiliac joint pain. The reassessment illustrates that Chou et al have utilized multiple studies inappropriately and have excluded appropriate studies. Also, Chou et al failed to eliminate their bias in their study evaluations. Conclusion: The reassessment, using appropriate methodology and including high quality studies, shows evidence that differs from published APS guidelines.


Falco F.J.E.,Mid Atlantic Spine and Pain Physicians of Newark | Benyamin R.,Millennium Pain Center | Helm II S.,Pacific Coast Pain Management Center | Parr A.T.,Premier Pain Center | Hirsch J.A.,Harvard University
Pain Physician | Year: 2011

The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician's best medical judgement and patient's best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice. This manuscript describes the framework of PCORI, and the role of CER and its impact on interventional pain management.


Background: Low back pain without disc herniation is the most common problem among chronic pain disorders. Epidural injections are commonly used interventions in managing chronic low back pain without disc herniation. However, little evidence exists regarding the effectiveness, indications, and medical necessity of lumbar epidural injections in managing axial low back pain without disc herniation or radiculitis. Study Design: A randomized, double-blind, controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the ability to provide effective and long-lasting pain relief with lumbar interlaminar epidural injections with local anesthetic with or without steroids in managing chronic low back pain not caused by disc herniation or radiculitis. Methods: Patients were randomly assigned to one of 2 groups with Group I patients receiving local anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Outcome measures included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments were done at baseline, 3 months, 6 months, and 12 months post-treatment. Significant pain relief and/or improvement in disability were defined as at least 50% improvement. Results: Significant pain relief (> 50%) was demonstrated in 74% of patients in Group I and 63% in Group II. Functional status improvement (reduction of > 50%) in the ODI scores was seen in 71% of patients in Group I and 60% of patients in Group II. The overall average procedures per year were approximately 4. Limitations: The results of this study are limited by the lack of a placebo group and that it is a preliminary report of 35 patients in each group with a total of 70 patients. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids was effective in 63% and 74% of patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis.


Vallejo R.,Millennium Pain Center | Vallejo R.,Illinois State University | Vallejo R.,Centro Medico Teknon | Barkin R.L.,Rush University | And 2 more authors.
Pain Physician | Year: 2011

The perpetual pursuit of pain elimination has been constant throughout human history and pervades human cultures. In some ways it is as old as medicine itself. Cultures throughout history have practiced the art of pain management through remedies such as oral ingestion of herbs or techniques believed to have special properties. In fact, even Hippocrates wrote about the practice of trepanation, the cutting of holes in the body to release pain. Current therapies for management of pain include the pervasive utilization of opioids, which have an extensive history, spanning centuries. There is general agreement about the appropriateness of opioids for the treatment of acute and cancer pain, but the long-term use of these drugs for treatment of chronic non-malignant pain remains controversial. The pros and cons regarding these issues are beyond the scope of this review. Instead, the purpose of this review will be directed towards the pharmacology of commonly prescribed opioids in the treatment of various chronic pain syndromes. Opium, derived from the Greek word for "juice," is extracted from the latex sap of the opium poppy (Papaverum somniferum). The juice of the poppy is the source of some 20 different alkaloids of opium. These alkaloids of opioids can be divided into 2 chemical classes: phenanthrenes (morphine, codeine, and thebaine) and benzylisoquinolines (agents that do not interact with opioid receptors).


Mekhail N.,Cleveland Clinic | Vallejo R.,Illinois State University | Coleman M.H.,The Spine Center Baltimore | Benyamin R.M.,Millennium Pain Center | Benyamin R.M.,University of Illinois at Urbana - Champaign
Pain Practice | Year: 2012

Background: Lumbar spinal stenosis (LSS) generally occurs from a combination of degenerative changes occurring in the lumbar spine. These include hypertrophy of ligamentum flavum, facet joint arthritic changes and bulging of the intervertebral disk. Spinal stenosis leads to compression of the lumbar neural elements (cauda equina), which manifests as low back and leg pain especially on standing and walking known as "neurogenic claudication." Current treatment options for LSS are varied. Conservative management, including physical therapy with/without epidural steroid injections, may be adequate for mild stenosis. Surgical decompression is reserved for severe cases and results in variable degrees of success. Patients with moderate-to-severe LSS having ligamentum flavum hypertrophy as a key contributor are generally inappropriately treated or undertreated. This is due to ineffectiveness of conservative therapy and possibility that major surgical compression might be too aggressive. Percutaneous decompression offers a possible solution for this patient population. Methods: One-year follow-up study was conducted at 11 U.S. sites. Study cohort included 58 mild ® percutaneous decompression patients who underwent 170 procedures, the majority treated bilaterally at one or two lumbar levels. Outcome measures included the visual analog scale (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 ® Health Survey. Results: No major mild ® device or procedure-related complications were reported. One-year data showed significant reduction of pain as measured by VAS. Improvement in physical functionality, mobility, and disability was significant as measured by ZCQ, SF-12v2, and ODI. Conclusions: At 1year this 58-patient cohort demonstrated continued excellent safety profile of the mild ® procedure and equally important, showed long-term pain relief and improved functionality. © 2011 The Authors. Pain Practice © 2011 World Institute of Pain.


Benyamin R.M.,Millennium Pain Center | Staats P.S.,Premier Pain Centers
Pain Physician | Year: 2015

Background: Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Study Design: Prospective, multi-center, randomized controlled, clinical study. Setting: Twenty-six interventional pain management centers throughout the United States. Objective: To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Methods: Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. Outcome Measures: The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. Results: Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. Limitations: Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. Conclusions: This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients. © 2015, American Society of Interventional Pain Physicians. All rights reserved.


Tiede J.,U.S. Army | Brown L.,Coastal Orthopedics | Gekht G.,Coastal Orthopedics | Vallejo R.,Millennium Pain Center | And 2 more authors.
Neuromodulation | Year: 2013

Objectives To examine the feasibility of novel high-frequency spinal cord stimulation therapy in a cohort of patients with chronic predominant back pain during a four day, percutaneous trial. Design Prospective, multicenter open label pilot trial. Setting and Patients: Twenty-four patients with back pain greater than leg pain who were candidates for spinal cord stimulation were trialed at five U.S. centers. Interventions Patients completed a percutaneous trial with a commercially available spinal cord stimulator. The implanted leads were then connected to the novel external stimulation device and patients were trialed for an additional four days. Outcome Measures Pain intensity ratings, subjective descriptions, and patients' preference. Results There was significant improvement from baseline in overall pain scores (8.68 to 2.03, [p < 0.001]) and back pain scores (8.12 to 1.88, [p < 0.001]) with the investigational stimulation. The investigational stimulation was preferred to the commercially available systems in 21 of 24 patients (88%). Conclusions Patients with predominant back pain reported a substantial reduction in overall pain and back pain when trialed with high-frequency spinal cord stimulation therapy. © 2013 International Neuromodulation Society.

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