Publications by authors named "Bradley W Wargo"

30 Publications

  • Page 1 of 1

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

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

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

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

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

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

Methods: The data for the analysis was obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2020.

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

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

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

Download full-text PDF

Source
May 2022

Equivalent Outcomes of Lumbar Therapeutic Facet Joint Nerve Blocks and Radiofrequency Neurotomy: Comparative Evaluation of Clinical Outcomes and Cost Utility.

Pain Physician 2022 03;25(2):179-192

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

Background: Chronic low back pain secondary to facet joint pathology is prevalent in 27% to 40% of selected populations using controlled comparative local anesthetic blocks. Lumbar facet joint nerve blocks and radiofrequency neurotomy are the most common interventional procedures for lower back pain. Nonetheless, questions remain regarding the effectiveness of each modality. Moreover, there is no agreement in reference to superiority or inferiority of lumbar facet joint nerve blocks when compared with radiofrequency neurotomy. Centers for Medicare and Medicaid Services (CMS) and almost all payers prefer radiofrequency ablation. Both procedures have been extensively studied with randomized controlled trials, systematic reviews, and cost utility analysis.

Objective: To assess the clinical outcomes and cost utility of therapeutic lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) compared with radiofrequency neurotomy in managing chronic low back pain of facet joint origin.

Study Design: A retrospective, case-control, comparative evaluation of outcomes and cost utility.

Setting: The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States.

Methods: The study was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology Analysis (STROBE) criteria. Only the patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic local anesthetic blocks were included.The main outcome measure was pain relief measured by the Numeric Rating Scale (NRS) evaluated at 3, 6, and 12 months. Significant improvement was defined as at least 50% improvement in pain relief. Cost utility was calculated utilizing direct payment data for the procedures with the addition of estimated indirect costs over a period of one year based on highly regarded surgical literature and previously published interventional pain management literature.

Results: A total of 326 patients met the inclusion criteria with 99 patients receiving lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) and 227 receiving lumbar radiofrequency neurotomy. Forty-eight patients in the facet joint nerve block group and 148 patients in the radiofrequency group completed one-year follow-up. Patients experienced significant improvement in both groups from baseline to 12 months with significant pain relief (≥ 50%) Significant pain relief was recorded in 100%, 99%, and 79% of the patients in the facet joint nerve block group, whereas, it was 100%, 74%, and 65% in the radiofrequency neurotomy group at the 3, 6, and 12 month follow-up, with a significant difference at 6 months. Cost utility analysis showed average costs for quality-adjusted life year (QALY) of $4,664 for lumbar facet joint nerve blocks and $5,446 for lumbar radiofrequency neurotomy. Twelve patients (12%) in the lumbar facet joint nerve block group and 79 patients (35%) in the lumbar radiofrequency group were converted to other treatments, either due to side effects or inadequate relief.

Conclusion: This study shows similar outcomes of therapeutic lumbar facet joint nerve blocks when compared with radiofrequency neurotomy as indicated by significant pain relief and cost utility.
View Article and Find Full Text PDF

Download full-text PDF

Source
March 2022

The Anesthesiology Milestones 2.0: An Improved Competency-Based Assessment for Residency Training.

Anesth Analg 2021 08;133(2):353-361

Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

The evolution of medical education, from a time-based to a competency-based platform, began nearly 30 years ago and continues to slowly take shape. The development of valid and reproducible assessment tools is the first step. Medical educators across specialties acknowledge the challenges and remain motivated to develop a relevant, generalizable, and measurable system. The Accreditation Council for Graduate Medical Education (ACGME) remains committed to its responsibility to the public by assuring that the process and outcome of graduate medical education in the nation's residency programs produce competent, safe, and compassionate doctors. The Milestones Project is the ACGME's current strategy in the evolution to a competency-based system, which allows each specialty to develop its own set of subcompetencies and 5-level progression, or milestones, along a continuum of novice to expert. The education community has now had nearly 5 years of experience with these rubrics. While not perfect, Milestones 1.0 provided important foundational information and insights. The first iteration of the Anesthesiology Milestones highlighted some mismatch between subcompetencies and current and future clinical practices. They have also highlighted challenges with assessment and evaluation of learners, and the need for faculty development tools. Committed to an iterative process, the ACGME assembled representatives from stakeholder groups within the Anesthesiology community to develop the second generation of Milestones. This special article describes the foundational data from Milestones 1.0 that was useful in the development process of Milestones 2.0, the rationale behind the important changes, and the additional tools made available with this iteration.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1213/ANE.0000000000005499DOI Listing
August 2021

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

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

, Advanced Pain Institute, Covington, LA.

Background: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines.

Objective: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine.

Methods: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided.

Results: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections.

Limitations: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain.

Conclusions: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.
View Article and Find Full Text PDF

Download full-text PDF

Source
January 2021

Triaging Interventional Pain Procedures During COVID-19 or Related Elective Surgery Restrictions: Evidence-Informed Guidance from the American Society of Interventional Pain Physicians (ASIPP).

Pain Physician 2020 08;23(4S):S183-204

Sutter Gould Medical Foundation, Stockton, CA.

Background: The COVID-19 pandemic has worsened the pain and suffering of chronic pain patients due to stoppage of "elective" interventional pain management and office visits across the United States. The reopening of America and restarting of interventional techniques and elective surgical procedures has started. Unfortunately, with resurgence in some states, restrictions are once again being imposed. In addition, even during the Phase II and III of reopening, chronic pain patients and interventional pain physicians have faced difficulties because of the priority selection of elective surgical procedures.Chronic pain patients require high intensity care, specifically during a pandemic such as COVID-19. Consequently, it has become necessary to provide guidance for triaging interventional pain procedures, or related elective surgery restrictions during a pandemic.

Objectives: The aim of these guidelines is to provide education and guidance for physicians, healthcare administrators, the public and patients during the COVID-19 pandemic. Our goal is to restore the opportunity to receive appropriate care for our patients who may benefit from interventional techniques.

Methods: The American Society of Interventional Pain Physicians (ASIPP) has created the COVID-19 Task Force in order to provide guidance for triaging interventional pain procedures or related elective surgery restrictions to provide appropriate access to interventional pain management (IPM) procedures in par with other elective surgical procedures. In developing the guidance, trustworthy standards and appropriate disclosures of conflicts of interest were applied with a section of a panel of experts from various regions, specialties, types of practices (private practice, community hospital and academic institutes) and groups. The literature pertaining to all aspects of COVID-19, specifically related to epidemiology, risk factors, complications, morbidity and mortality, and literature related to risk mitigation and stratification was reviewed. The evidence -- informed with the incorporation of the best available research and practice knowledge was utilized, instead of a simplified evidence-based approach. Consequently, these guidelines are considered evidence-informed with the incorporation of the best available research and practice knowledge.

Results: The Task Force defined the medical urgency of a case and developed an IPM acuity scale for elective IPM procedures with 3 tiers. These included urgent, emergency, and elective procedures. Examples of urgent and emergency procedures included new onset or exacerbation of complex regional pain syndrome (CRPS), acute trauma or acute exacerbation of degenerative or neurological disease resulting in impaired mobility and inability to perform activities of daily living. Examples include painful rib fractures affecting oxygenation and post-dural puncture headaches limiting the ability to sit upright, stand and walk. In addition, emergency procedures include procedures to treat any severe or debilitating disease that prevents the patient from carrying out activities of daily living. Elective procedures were considered as any condition that is stable and can be safely managed with alternatives.

Limitations: COVID-19 continues to be an ongoing pandemic. When these recommendations were developed, different stages of reopening based on geographical regulations were in process. The pandemic continues to be dynamic creating every changing evidence-based guidance. Consequently, we provided evidence-informed guidance.

Conclusion: The COVID-19 pandemic has created unprecedented challenges in IPM creating needless suffering for pain patients. Many IPM procedures cannot be indefinitely postponed without adverse consequences. Chronic pain exacerbations are associated with marked functional declines and risks with alternative treatment modalities. They must be treated with the concern that they deserve. Clinicians must assess patients, local healthcare resources, and weigh the risks and benefits of a procedure against the risks of suffering from disabling pain and exposure to the COVID-19 virus.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2020

Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines.

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

Axis Spine Center, Coeur d'Alene, ID.

Background: Chronic axial spinal pain is one of the major causes of significant disability and health care costs, with facet joints as one of the proven causes of pain.

Objective: To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions.

Methods: The methodology utilized included the development of objectives and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of facet joint interventions, was reviewed, with a best evidence synthesis of available literature and utilizing grading for recommendations.Summary of Evidence and Recommendations:Non-interventional diagnosis: • The level of evidence is II in selecting patients for facet joint nerve blocks at least 3 months after onset and failure of conservative management, with strong strength of recommendation for physical examination and clinical assessment. • The level of evidence is IV for accurate diagnosis of facet joint pain with physical examination based on symptoms and signs, with weak strength of recommendation. Imaging: • The level of evidence is I with strong strength of recommendation, for mandatory fluoroscopic or computed tomography (CT) guidance for all facet joint interventions. • The level of evidence is III with weak strength of recommendation for single photon emission computed tomography (SPECT) . • The level of evidence is V with weak strength of recommendation for scintography, magnetic resonance imaging (MRI), and computed tomography (CT) .Interventional Diagnosis:Lumbar Spine: • The level of evidence is I to II with moderate to strong strength of recommendation for lumbar diagnostic facet joint nerve blocks. • Ten relevant diagnostic accuracy studies with 4 of 10 studies utilizing controlled comparative local anesthetics with concordant pain relief criterion standard of ≥80% were included. • The prevalence rates ranged from 27% to 40% with false-positive rates of 27% to 47%, with ≥80% pain relief.Cervical Spine: • The level of evidence is II with moderate strength of recommendation. • Ten relevant diagnostic accuracy studies, 9 of the 10 studies with either controlled comparative local anesthetic blocks or placebo controls with concordant pain relief with a criterion standard of ≥80% were included. • The prevalence and false-positive rates ranged from 29% to 60% and of 27% to 63%, with high variability. Thoracic Spine: • The level of evidence is II with moderate strength of recommendation. • Three relevant diagnostic accuracy studies, with controlled comparative local anesthetic blocks, with concordant pain relief, with a criterion standard of ≥80% were included. • The prevalence varied from 34% to 48%, whereas false-positive rates varied from 42% to 58%.Therapeutic Facet Joint Interventions: Lumbar Spine: • The level of evidence is II with moderate strength of recommendation for lumbar radiofrequency ablation with inclusion of 11 relevant randomized controlled trials (RCTs) with 2 negative studies and 4 studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic lumbar facet joint nerve blocks with inclusion of 3 relevant randomized controlled trials, with long-term improvement. • The level of evidence is IV with weak strength of recommendation for lumbar facet joint intraarticular injections with inclusion of 9 relevant randomized controlled trials, with majority of them showing lack of effectiveness without the use of local anesthetic. Cervical Spine: • The level of evidence is II with moderate strength of recommendation for cervical radiofrequency ablation with inclusion of one randomized controlled trial with positive results and 2 observational studies with long-term improvement. • The level of evidence is II with moderate strength of recommendation for therapeutic cervical facet joint nerve blocks with inclusion of one relevant randomized controlled trial and 3 observational studies, with long-term improvement. • The level of evidence is V with weak strength of recommendation for cervical intraarticular facet joint injections with inclusion of 3 relevant randomized controlled trials, with 2 observational studies, the majority showing lack of effectiveness, whereas one study with 6-month follow-up, showed lack of long-term improvement. Thoracic Spine: • The level of evidence is III with weak to moderate strength of recommendation with emerging evidence for thoracic radiofrequency ablation with inclusion of one relevant randomized controlled trial and 3 observational studies. • The level of evidence is II with moderate strength of recommendation for thoracic therapeutic facet joint nerve blocks with inclusion of 2 randomized controlled trials and one observational study with long-term improvement. • The level of evidence is III with weak to moderate strength of recommendation for thoracic intraarticular facet joint injections with inclusion of one randomized controlled trial with 6 month follow-up, with emerging evidence. Antithrombotic Therapy: • Facet joint interventions are considered as moderate to low risk procedures; consequently, antithrombotic therapy may be continued based on overall general status. Sedation: • The level of evidence is II with moderate strength of recommendation to avoid opioid analgesics during the diagnosis with interventional techniques. • The level of evidence is II with moderate strength of recommendation that moderate sedation may be utilized for patient comfort and to control anxiety for therapeutic facet joint interventions.

Limitations: The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy.

Conclusions: These facet joint intervention guidelines were prepared with a comprehensive review of the literature with methodologic quality assessment with determination of level of evidence and strength of recommendations.

Key Words: Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.
View Article and Find Full Text PDF

Download full-text PDF

Source
May 2020

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP).

Pain Physician 2020 03;23(2):E85-E131

Pain Management Centers of America.

Background: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration's (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.

Objectives: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around "minimal manipulation" and "homologous use" within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine.

Methods: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980's and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA's intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs.

Conclusions: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.

Key Words: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption.
View Article and Find Full Text PDF

Download full-text PDF

Source
March 2020

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

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

Georgia Pain Care, Atlanta, GA.

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

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

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

Download full-text PDF

Source
February 2017

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

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

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

Background: Epidural injections have been used since 1901 in managing low back pain and sciatica. Spinal pain, disability, health, and economic impact continue to increase, despite numerous modalities of interventions available in managing chronic spinal pain. Thus far, systematic reviews performed to assess the efficacy of epidural injections in managing chronic spinal pain have yielded conflicting results.

Objective: To evaluate and update the clinical utility of the efficacy of epidural injections in managing chronic spinal pain.

Study Design: A systematic review of randomized controlled trials of epidural injections in managing chronic spinal pain.

Methods: In this systematic review, randomized trials with a placebo control or an active-control design were included. The outcome measures were pain relief and functional status improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Best evidence synthesis was conducted based on the qualitative level of evidence (Level I to V). Data sources included relevant literature identified through searches of PubMed for a period starting in 1966 through August 2015; Cochrane reviews; and manual searches of the bibliographies of known primary and review articles.

Results: A total of 52 trials met inclusion criteria. Meta-analysis was not feasible. The evidence in managing lumbar disc herniation or radiculitis is Level II for long-term improvement either with caudal, interlaminar, or transforaminal epidural injections with no significant difference among the approaches. The evidence is Level II for long-term management of cervical disc herniation with interlaminar epidural injections. The evidence is Level II to III in managing thoracic disc herniation with an interlaminar approach. The evidence is Level II for caudal and lumbar interlaminar epidural injections with Level III evidence for lumbar transforaminal epidural injections for lumbar spinal stenosis. The evidence is Level III for cervical spinal stenosis management with an interlaminar approach. The evidence is Level II for axial or discogenic pain without facet arthropathy or disc herniation treated with caudal or lumbar interlaminar injections in the lumbar region; whereas it is Level III in the cervical region treated with cervical interlaminar epidural injections. The evidence for post lumbar surgery syndrome is Level II with caudal epidural injections and for post cervical surgery syndrome it is Level III with cervical interlaminar epidural injections.

Limitations: Even though this is a large systematic review with inclusion of a large number of randomized controlled trials, the paucity of high quality randomized trials literature continues to confound the evidence.

Conclusion: This systematic review, with an assessment of the quality of manuscripts and outcome parameters, shows the efficacy of epidural injections in managing a multitude of chronic spinal conditions.
View Article and Find Full Text PDF

Download full-text PDF

Source
November 2015

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

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

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

Background: The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate.

Objective: To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain.

Study Design: A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain.

Methods: The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for randomized trials and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, and manual searches of the bibliographies of known primary and review articles.

Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption.

Results: A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement.

Limitations: The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections.

Conclusion: Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy.
View Article and Find Full Text PDF

Download full-text PDF

Source
February 2016

A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up.

Pain Physician 2013 Sep-Oct;16(5):465-78

Pain Management Center of Paducah, Paducah, KY; and University of Louisville, Louisville, KY; and The McFarland Clinic, Mary Greeley Medical Center, Ames, Iowa.

Background: A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck pain as the fourth condition leading to disability, with low back pain being the number one. Multiple treatment modalities have been described in managing neck and upper extremity pain secondary to cervical disc herniation after the failure of conservative management. The treatment modalities for chronic persistent pain of cervical disc herniation include surgery and epidural injections. The growth of interventional techniques in managing chronic spinal pain in recent years has been enormous. Evidence for the efficacy of cervical interlaminar epidural injections, however, continues to be debated, despite positive evidence derived from controlled randomized trials and systematic reviews.

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

Setting: A private, specialty referral, interventional pain management practice in the United States.

Objectives: To evaluate the effectiveness of epidural injections in managing chronic pain related to cervical disc herniation.

Methods: Patients were randomly assigned to one of 2 groups of 60, with a total of 120 patients. Group I patients received cervical epidural injections with lidocaine 0.5% preservative-free, 5 mL, whereas Group II patients received 0.5% preservative-free lidocaine mixed with 1 mL or 6 mg of non-particulate betamethasone.

Outcome Assessment: Multiple outcome measures included the numeric rating pain scale (NRS), the Neck Disability Index (NDI), employment status, opioid intake with assessment at 3, 6, 12, 18, and 24 months post treatment. Significant improvement was described as pain relief with a 50% improvement in functional status.

Results: This evaluation showed significant improvement as 50% pain relief and improvement in functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and 68% in those patients receiving local anesthetic and steroid. In the successful group of participants however, significant improvement was seen in 77% in Group I and 80% in Group II. Overall, the average number of procedures was 5 to 6 in both groups. The average total relief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful group of participants. Taking into consideration all of the participants, the average total relief for 2 years was 69.6 ± 35 weeks in Group I and 62.1 ± 38.4 weeks in Group II.

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

Conclusion: Cervical epidural injections with local anesthetic with or without steroids. [corrected].
View Article and Find Full Text PDF

Download full-text PDF

Source
May 2014

Assessment of bleeding risk of interventional techniques: a best evidence synthesis of practice patterns and perioperative management of anticoagulant and antithrombotic therapy.

Pain Physician 2013 Apr;16(2 Suppl):SE261-318

Pain Management Center of Paducah, Paducah, KY, USA.

Background: Interventional pain management is a specialty that utilizes invasive procedures to diagnose and treat chronic pain. Patients undergoing these treatments may be receiving exogenous anticoagulants and antithrombotics. Even though the risk of major bleeding is very small, the consequences can be catastrophic. However, the role of antithrombotic therapy for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events is also crucial. Overall, there is a paucity of literature on the subject of bleeding risk in interventional pain management along with practice patterns and perioperative management of anticoagulant and anti-thrombotic therapy.

Study Design: Best evidence synthesis.

Objective: To critically appraise and synthesize the literature with assessment of the bleeding risk of interventional techniques including practice patterns and perioperative management of anticoagulant and antithrombotic therapy.

Methods: The available literature on the bleeding risk of interventional techniques and practice patterns and perioperative management of anticoagulant and antithrombotic therapy was reviewed. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2012 and manual searches of the bibliographies of known primary and review articles.

Results: There is good evidence for the risk of thromboembolic phenomenon in patients who discontinue antithrombotic therapy, spontaneous epidural hematomas occur with or without traumatic injury in patients with or without anticoagulant therapy associated with stressors such as chiropractic manipulation, diving, and anatomic abnormalities such as ankylosing spondylitis, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. There is fair evidence that excessive bleeding, including epidural hematoma formation may occur with interventional techniques when antithrombotic therapy is continued, the risk of thromboembolic phenomenon is higher than the risk of epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques, to continue phosphodiesterase inhibitors (dipyridamole [Persantine], cilostazol [Pletal], and Aggrenox [aspirin and dipyridamole]), and that anatomic conditions such as spondylosis, ankylosing spondylitis and spinal stenosis, and procedures involving the cervical spine; multiple attempts; and large bore needles increase the risk of epidural hematoma; and rapid assessment and surgical or nonsurgical intervention to manage patients with epidural hematoma can avoid permanent neurological complications. There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy clopidogrel (Plavix), ticlopidine (Ticlid), or prasugrel (Effient) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxaban (Xarelto) to discontinue to avoid bleeding and epidural hematomas during interventional techniques and to continue to avoid cerebrovascular and cardiovascular thromboembolic events.

Recommendations: The recommendations derived from the comprehensive assessment of the literature and guidelines are to continue NSAIDs and low dose aspirin, and phosphodiesterase inhibitors (dipyridamole, cilostazol, Aggrenox) during interventional techniques. However, the recommendations for discontinuation of antiplatelet therapy with platelet aggregation inhibitors (clopidogrel, ticlopidine, prasugrel) is variable with clinical judgment to continue or discontinue based on the patient's condition, the planned procedure, risk factors, and desires, and the cardiologist's opinion. Low molecular weight heparin (LMWH) or unfractionated heparin may be discontinued 12 hours prior to performing interventional techniques. Warfarin should be discontinued or international normalized ratio (INR) be normalized to 1.4 or less for high risk procedures and 2 or less for low risk procedures based on risk factors. It is also recommended to discontinue Pradaxa for 24 hours for paravertebral interventional techniques in 2 to 4 days for epidural interventions in patients with normal renal function and for longer periods of time in patients with renal impairment, and to discontinue rivaroxaban for 24 hours prior to performing interventional techniques.

Limitations:   The paucity of the literature.

Conclusion: Based on the available literature including guidelines, the recommendations in patients with antithrombotic therapy for therapy prior to interventional techniques are provided.
View Article and Find Full Text PDF

Download full-text PDF

Source
April 2013

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations.

Pain Physician 2013 Apr;16(2 Suppl):S49-283

American Society of Interventional Pain Physicians.

Objective: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain.

Methodology: Systematic assessment of the literature.

Evidence: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events.

Conclusions: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed.

Disclaimer: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."
View Article and Find Full Text PDF

Download full-text PDF

Source
April 2013

Systematic review of the therapeutic effectiveness of cervical facet joint interventions: an update.

Pain Physician 2012 Nov-Dec;15(6):E839-68

Mid Atlantic Spine & Pain Physicians of Newark, Newark, DE, USA.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
June 2013

Assessment of infection control practices for interventional techniques: a best evidence synthesis of safe injection practices and use of single-dose medication vials.

Pain Physician 2012 Sep-Oct;15(5):E573-614

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

Background: It is universally accepted that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration practices by health care professionals in various clinical settings. This resulted in development of multiple guidelines based on case reports; however, these case reports are confounded by multiple factors without causal relationship to a single factor. Even then, single-dose vials used for multiple patients have been singled out and became the focus of infection control policies resulting in inordinate expenses for practices without improving patient safety. The cost of implementation of single dose vial policy in interventional pain management for drugs alone may cost $750 million, whereas with single use radional gloves may exceed $1 billion per year.

Study Design: Best evidence synthesis.

Objective: To critically appraise and synthesize the literature on infection control practices for interventional techniques, including safe injection and medication vial utilization.

Methods: The available literature on infection control practices was reviewed. Due to the nature of the studies involved, with the majority being case reports, and a few prospective evaluations, quality assessment and clinical relevance criteria were not applied. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, literature from the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and manual searches of the bibliographies of known primary and review articles.

Outcome Measures: The primary outcome measure was correlating infection to a breach of standards in infection control practices. The secondary objective was to assess the contribution of single-dose vials independently for infection.

Results: A total of 60 reports met inclusion criteria, with 16 reports related to pain management and other procedures, of which 9 reports were attributed to issues related to interventional techniques. Based on an estimated 37 infections occurring during 200 million interventional techniques from 1997 through 2011, the rate of infection is speculated to be one infection for every 5 million interventional pain management procedures. However, if 10 times more infections are estimated, the infection rate appears to be one infection for every 500,000 interventional pain management procedures. The evidence is good for infection related to a breach of infection control practices. There is good evidence that contamination of multi-dose or single-dose vials can contribute to infection. There was poor evidence that the use of single-dose vials on multiple patients with appropriate infection control practices cause infection in interventional pain management.

Limitations: The limitations of this comprehensive best evidence synthesis include the paucity of literature and dependence of governmental agencies on their literature without applying Institute of Medicine (IOM) criteria for guideline synthesis.

Conclusion: There is good evidence that any breach of sterile practice may result in serious and life threatening infections. There is poor evidence for single-dose vials as a sole factor causing infections when used in multiple patients in interventional pain management settings.
View Article and Find Full Text PDF

Download full-text PDF

Source
February 2013

Management of chronic pain of cervical disc herniation and radiculitis with fluoroscopic cervical interlaminar epidural injections.

Int J Med Sci 2012 23;9(6):424-34. Epub 2012 Jul 23.

Pain Management Center of Paducah, Paducah, KY, USA.

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

Objective: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis.

Summary Of Background Data: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature.

Methods: One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight.

Results: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group.

Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7150/ijms.4444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3410361PMC
January 2013

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

Pain Physician 2012 Jul;15(3 Suppl):S67-116

American Society of Interventional Pain Physicians, USA.

Results: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. (

Evidence: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. (

Evidence: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. (

Evidence: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. (

Evidence: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. (

Evidence: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. (

Evidence: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. (

Evidence: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. (

Evidence: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (

Evidence: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. (

Evidence: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. (

Evidence: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. (

Evidence: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. (

Evidence: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. (

Evidence: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. (

Evidence: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. (

Evidence: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. (

Evidence: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. (

Evidence: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. (

Evidence: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. (

Evidence: fair).

Disclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."
View Article and Find Full Text PDF

Download full-text PDF

Source
July 2012

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

Pain Physician 2012 Jul;15(3 Suppl):S1-65

American Society of Interventional Pain Physicians, USA.

Background: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment.

Objectives: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids.

Results: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping.

Disclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."
View Article and Find Full Text PDF

Download full-text PDF

Source
July 2012

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

Pain Physician 2012 Mar-Apr;15(2):E143-50

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

Background: Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks.

Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.

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

Objectives: Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively.

Methods: This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated.

Outcomes Assessment: Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications.

Results: There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar region, and 6% in thoracic region; local bleeding in 76.3% of episodes with highest in thoracic region and lowest in cervical region; oozing with 19.6% encounters with highest in cervical region and lowest in lumbar region; with local hematoma seen only in 1.2% of the patients with profuse bleeding, bruising, soreness, nerve root irritation, and all other effects such as vasovagal reactions observed in 1% or less of the episodes.

Limitations: Limitations of this study include lack of contrast injection, use of intermittent fluoroscopy and also an observational nature of the study.

Conclusion: This study illustrate that major complications are extremely rare and minor side effects are common.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2012

A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections.

Pain Physician 2012 Mar-Apr;15(2):131-40

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

Background: Among the multiple modalities of treatments available in managing chronic spinal pain, including surgery and multiple interventional techniques, epidural injections by various routes, such as interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, and percutaneous adhesiolysis are common. Even though the complications of fluoroscopically directed epidural injections are fewer than blind epidural injections, and have better effectiveness, multiple complications have been reported in scattered case reports, with only minor complications in randomized or non-randomized studies and systematic reviews. Thus, prospective studies with large patient series are essential to determine the types and incidences of complications.

Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.

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

Objectives: To assess the complication rate of fluoroscopically directed epidural injections.

Methods: This study was carried out over a period of 20 months and included over 10,000 procedures: 39% caudal epidurals, 23% cervical interlaminar epidurals, 14% lumbar interlaminar epidurals, 13% lumbar transforaminal epidurals, 8% percutaneous adhesiolysis, and 3% thoracic interlaminar epidural procedures. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated.

Outcomes Assessment: Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, bruising, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, infectious complications, vasovagal reactions, and facial flushing.

Results: Intravascular entry was higher for adhesiolysis (11.6%) and lumbar transforaminal (7.9%) procedures compared to other epidurals which ranged from 0.5% for lumbar, 3.1% for caudal, 4% for thoracic, and 4.1% for cervical epidurals. Dural puncture was observed in a total of 0.5% of the procedures with 1% in the cervical region, 1.3% in the thoracic region, 0.8% with lumbar interlaminar epidurals, and 1.8% with adhesiolysis.

Limitations: Limitations of this study include a single-center study even though it included a large number of patients.

Conclusion: This study illustrates that major complications are rare and minor side effects are common.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2012

Preoperative fasting before interventional techniques: is it necessary or evidence-based?

Pain Physician 2011 Sep-Oct;14(5):459-67

Pain Management Center of Paducah, Paducah, KY.

Background: Interventional pain management is an evolving specialty. Multiple issues including preoperative fasting, sedation, and infection control have not been well investigated and addressed. Based on the necessity for sedation and also the adverse events related to interventional techniques, preoperative fasting is considered practical to avoid postoperative nausea and vomiting. However, there are no guidelines for interventional techniques for sedation or fasting. Most interventional techniques are performed under intravenous or conscious sedation.

Objective: To assess the need for preoperative fasting and risks without fasting in patients undergoing interventional techniques.

Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.

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

Methods: All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including nausea and vomiting.

Results: From May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures, with patients receiving sedation during 11,856 encounters. Only 189, or 1.6% of the patients complained of nausea and 3 of them, or 0.02%, experienced vomiting. There were no aspirations. Of the 189 patients with nausea, 80 of them improved significantly prior to discharge without further complaints. Overall, 109 patients, or 0.9% were minimally nauseated prior to discharge. The postoperative complaints of continued nausea were reported in only 26 patients for 6 to 72 hours. There were only 2 events of respiratory depression, which were managed with brief oxygenation with mask without any adverse consequence of nausea, vomiting, aspiration, or other adverse effects.

Limitations: Limitations include the nonrandomized observational nature of the study.

Conclusion: This study illustrates that postoperative nausea, vomiting, and respiratory depression are extremely rare and aspiration is almost nonexistent, despite almost all of the patients receiving sedation and without preoperative fasting prior to provision of the interventional techniques.  
View Article and Find Full Text PDF

Download full-text PDF

Source
January 2012

Infection control practices (safe injection and medication vial utilization) for interventional techniques: are they based on relative risk management or evidence?

Pain Physician 2011 Sep-Oct;14(5):425-34

Pain Management Center of Paducah, Paducah, KY, USA.

Background: Recently, multiple regulations and recommendations for safe infection control practices and safe injection and medication vial utilization have been implemented. These include single dose and multi-dose vials for a single patient and regulations. It is a well known fact that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration. Multiple case reports have been published illustrating the occurrence of infections in interventional pain management and other minor techniques because of lack of safe injection practices, and noncompliance with other precautions. However, there are no studies or case reports illustrating the transmission of infection due to the use of single dose vials in multiple patients when appropriate precautions are observed. Similarly, the preparation standards for simple procedures such as medial branch blocks or transforaminal epidurals have not been proven to be essential. Further, the effectiveness or necessity of surgical face masks and hats, etc., for interventional techniques has not been proven.

Objective: To assess the rates of infection in patients undergoing interventional techniques.

Study Design: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.

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

Methods: All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including infection.

Results: May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures. A total of 12 patients reported suspicion of infection. All of them were evaluated by a physician and only one of them was a superficial infection due to the patient's poor hygienic practices which required no antibiotic therapy.

Limitations: Limitations include the nonrandomized observational nature of the study.

Conclusion: There were no infections of any significance noted in approximately 3,200 patients with over 18,000 procedures performed during a 20-month period in an ambulatory surgery center utilizing simple precautions for clean procedures with the use of single dose vials for multiple patients and using safe injection practices.
View Article and Find Full Text PDF

Download full-text PDF

Source
January 2012

A prospective evaluation of bleeding risk of interventional techniques in chronic pain.

Pain Physician 2011 Jul-Aug;14(4):317-29

Pain Management Center of Paducah, Paducah, KY, USA.

Background: The role of antithrombotic therapy is well known for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were continued. However, it has been a common practice to discontinue antiplatelet therapy prior to performing interventional techniques, which may potentially increase the risk of acute cerebral and cardiovascular events.

Study Design: A prospective study of 3,179 patients undergoing interventional techniques with 12,000 encounters and 18,472 procedures from May 2008 to December 2009.

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

Objective: To assess the rates of adverse events in patients undergoing interventional techniques on antithrombotic therapy with cessation or without cessation and compare them to a group of patients without antithrombotic therapy.

Methods: Measurable outcomes employed were intravascular entry of the needle, bruising, local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness.The prospective evaluation was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement which was developed with recommendations to improve the quality of reporting observational studies.

Results: The results of this study illustrated that in one-quarter (3,087) of patient encounters utilizing interventional pain management techniques, antithrombotic therapy was included. Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was continued during the interventional techniques, whereas, for 45%, or 1376 encounters, antithrombotic therapy was discontinued. Overall, these results illustrate that while intravascular penetration and oozing were higher in patients with continued antithrombotic therapy, bruising and local bleeding were higher in patients with discontinued antithrombotic therapy without any difference either statistical or clinical in any of the other aspects, either intraoperative, post procedure in the recovery room, or postoperative period.

Limitations: Limitations include the nonrandomized observational nature of the study and that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix).

Conclusion: No significant prevalence of adverse events was observed in those who continued with or ceased antithrombotic therapy.
View Article and Find Full Text PDF

Download full-text PDF

Source
November 2011

Comparative evaluation of the accuracy of benzodiazepine testing in chronic pain patients utilizing immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing.

Pain Physician 2011 May-Jun;14(3):259-70

Pain Management Center of Paducah, Paducah, KY 42003, USA.

Background: Eradicating or appreciably limiting controlled prescription drug abuse, such as opioids and benzodiazepines, continues to be a challenge for clinicians, while providing needed, proper treatment. Detection of misuse and abuse is facilitated with urine drug testing (UDT). However, there are those who dispute UDT's diagnostic accuracy when done in the office (immunoassay) and claim that laboratory confirmation using liquid chromatography tandem mass spectrometry (LC/MS/MS) is required in each and every examination.

Study Design: A diagnostic accuracy study of UDT.

Study Setting: The study was conducted in a tertiary referral center and interventional pain management practice in the United States.

Objective: Comparing UDT results of in-office immunoassay testing (the index test) with LC/MS/MS (the reference test).

Methods: A total of 1,000 consecutive patients were recruited to be participants. Along with demographic information, a urine sample was obtained from them. A nurse conducted the immunoassay testing at the interventional pain management practice location; a laboratory conducted the LC/MS/MS. All index test results were compared with the reference test results. The index test's efficiency (agreement) was calculated as were calculations for sensitivity, specificity, false-positive, and false-negative rates.

Results: Approximately 36% of the specimens required confirmation. The index test's efficiency for prescribed benzodiazepines was 78.4%. Reference testing improved accuracy to 83.2%, a 19.6% increase, and 8.9% of participants were found to be taking non-prescribed benzodiazepines. The index test's false-positive rate for benzodiazepines use was 10.5% in patients receiving benzodiazepines.

Limitations: This study was limited by its single-site location, its use of a single type of point of care (POC) kit, and reference testing being conducted by a single laboratory, as well as technical sponsorship.

Conclusion: Clinicians should feel comfortable conducting in-office UDT immunoassay testing. The present study shows that it is reliable, expedient, and fiscally sound for all involved. In-office immunoassay testing compares favorably with laboratory testing for benzodiazepines, offering both high specificity and agreement. However, clinicians should be vigilant and wary when interpreting results, weighing all factors involved in their decision.
View Article and Find Full Text PDF

Download full-text PDF

Source
April 2012

Comparative evaluation of the accuracy of immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing (UDT) opioids and illicit drugs in chronic pain patients.

Pain Physician 2011 Mar-Apr;14(2):175-87

Pain Management Center of Paducah, Paducah, KY, USA.

Background: The challenge for physicians in treating chronic pain with opioids is to eliminate or significantly curtail abuse of controlled prescription drugs while assuring proper treatment when indicated. Urine drug testing (UDT) has been shown to be a useful approach in identifying patterns of compliance, misuse, and abuse. However, significant controversy surrounds the diagnostic accuracy of UDT performed in the office (immunoassay) and the requirement for laboratory confirmation with liquid chromatography tandem mass spectrometry (LC/MS/MS).

Study Design: A diagnostic accuracy study of urine drug testing.

Study Setting: The study was performed in an interventional pain management practice, a tertiary referral center, in the United States.

Objective: The objective of this study was to compare the results of UDT of immunoassay in-office testing (index test) to LC/MS/MS (reference test).

Methods: One-thousand participants were recruited from an interventional pain management program. Urine sample was collected from all the consecutive patients with demographic information. Immunoassay testing was performed by a nurse at the location, laboratory assessment was performed with LC/MS/MS. Results of the index test were compared to the reference test in all patients. The sensitivity, specificity, false-positive, and false-negative rates, and index test efficiency (agreement) were calculated.

Results: Overall, results showed that confirmation was required in 32.9% of the specimens. Agreement for prescribed opioids was high with the index test (80.4%). The reference test of opioids improved the accuracy by 8.9% from 80.4% to 89.3%. Non-prescribed opioids were used by 5.3% of patients. The index test provided false-positive results for non-opioid use in 44% or 83 of 120 patients. For illicit drugs, the false-positive rate by index test was 0% for cocaine, whereas it was 2% for marijuana, 0.9% for amphetamines, and 1.2% for methamphetamines.

Limitations: The limitations include a single site study utilizing a single POC kit and a single laboratory, as well as technical sponsorship.

Conclusion: The UDT with immunoassay in an office setting is appropriate, convenient, and cost-effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay in-office testing had high specificity and agreement, demonstrating the value of immunoassay drug testing. Because of variable sensitivity, clinicians would be well-advised to take a cautious approach when interpreting the results.

Clinical Trial: NCT01052155.
View Article and Find Full Text PDF

Download full-text PDF

Source
July 2011

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

Pain Physician 2010 Jul-Aug;13(4):E265-78

Pain Management Center of Paducah, Paducah, KY, USA.

Background: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain.

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

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

Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain.

Methods: Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or 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: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction.

Results: Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group.

Limitations: The results of this study are limited by the lack of a placebo group and a preliminary report of 70 patients, with 35 patients in each group.

Conclusion: Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic.
View Article and Find Full Text PDF

Download full-text PDF

Source
March 2011

The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial.

Pain Physician 2010 May-Jun;13(3):223-36

Pain Management Center of Paducah, Paducah, KY, USA.

Background: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. Cervical disc herniation and radiculitis is one of the common conditions described responsible for chronic neck and upper extremity pain. Cervical epidural injections for managing chronic neck pain with disc herniation are one of the commonly performed non-surgical interventions in the United States. However, the literature supporting cervical interlaminar epidural steroids in managing chronic neck pain is scant.

Study Design: A randomized, double-blind, controlled trial.

Setting: A private interventional pain management practice and specialty referral center in the United States.

Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis, and to evaluate the differences between local anesthetic with or without steroids.

Methods: Patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of non-particulate betamethasone.

Outcomes Assessment: Multiple outcome measures were utilized. They included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments were done at baseline and 3, 6, and 12 months post-treatment. Significant pain relief was defined as 50% or more; significant improvement in disability score was defined as a reduction of 50% or more.

Results: Significant pain relief (> or = 50%) was demonstrated in 77% of patients in both groups. Functional status improvement was demonstrated by a reduction (> or = 50%) in the NDI scores in 74% of Group I and 71% of Group II at 12 months. The overall average procedures per year were 3.7 +/- 1.1 in Group I and 4.0 +/- 0.91 in Group II; the average total relief per year was 39.45 +/- 11.59 weeks in Group I and 41.06 +/- 11.56 weeks in Group II over the 52 week study period in the patients defined as successful. The initial therapy was considered to be successful if a patient obtained consistent relief with 2 initial injections lasting at least 4 weeks. All others were considered failures.

Limitations: The study results are limited by the lack of a placebo group and a preliminary report of 70 patients, 35 in each group.

Conclusion: Cervical interlaminar epidural injections with local anesthetic with or without steroids might be effective in 77% of patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical disc herniation and radiculitis.
View Article and Find Full Text PDF

Download full-text PDF

Source
August 2010

Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS).

Pain Physician 2010 Jan-Feb;13(1):E1-E22

Pain Management Center of Paducah, Paducah, KY, USA.

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing.

Study Design: A diagnostic accuracy study of urine drug testing.

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

Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample.

Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized.

Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated.

Limitations: The limitations include lack of availability of POC testing with lower cutoff levels.

Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics.

Clinical Trial Registration: NCT 01052155.
View Article and Find Full Text PDF

Download full-text PDF

Source
May 2010

Systematic review of diagnostic utility and therapeutic effectiveness of cervical facet joint interventions.

Pain Physician 2009 Mar-Apr;12(2):323-44

Mid Atlantic Spine & Pain Specialists, Newark, DE 19713, USA.

Background: Chronic, recurrent neck pain is common and is associated with high pain intensity and disability, which is seen in 14% 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. 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: A systematic review of cervical facet joint interventions.

Objective: To evaluate the accuracy of diagnostic facet joint nerve blocks and the effectiveness of cervical facet joint interventions.

Methods: Medical databases and journals were searched to locate all relevant literature from 1966 through December 2008 in the English language. A review of the literature of the utility of facet joint interventions in diagnosing and managing facet joint pain was performed according to the Agency for Healthcare Research and Quality (AHRQ) criteria for diagnostic studies and observational studies and the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials.

Level Of Evidence: The level of evidence was defined as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).

Outcome Measures: For diagnostic interventions, studies must have been performed utilizing controlled local anesthetic blocks which achieve at minimum 80% relief of pain and the ability to perform previously painful movements. For therapeutic interventions, the primary outcome measure was pain relief (short-term relief up to 6 months and long-term relief greater than 6 months) with secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake.

Results: Based on the utilization of controlled comparative local anesthetic blocks, the evidence for the diagnosis of cervical facet joint pain is Level I or II-1. The indicated evidence for therapeutic cervical medial branch blocks is Level II-1. The indicated evidence for radiofrequency neurotomy in the cervical spine is Level II-1 or II-2, whereas the evidence is lacking for intraarticular injections.

Limitations: A systematic review of cervical facet joint interventions is hindered by the paucity of published literature and lack of literature for intraarticular cervical facet joint injections.

Conclusions: The evidence for diagnosis of cervical facet joint pain with controlled comparative local anesthetic blocks is Level I or II-1. The indicated evidence for therapeutic facet joint interventions is Level II-1 for medial branch blocks, and Level II-1 or II-2 for radiofrequency neurotomy.
View Article and Find Full Text PDF

Download full-text PDF

Source
July 2009

Systematic review of cervical discography as a diagnostic test for chronic spinal pain.

Pain Physician 2009 Mar-Apr;12(2):305-21

Pain Management Center of Paducah, Paducah, KY 42003, USA.

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 often 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 cervical discography literature.

Objective: To evaluate the validity and usefulness of cervical provocation discography in managing and diagnosing discogenic pain by means of a systematic review.

Methods: Following a comprehensive search of the literature, selected studies were subjected to a modified Agency for Healthcare Research and Quality (AHRQ) diagnostic accuracy evaluation. Qualitative analysis was conducted using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II. The rating scheme was modified to evaluate the diagnostic accuracy.

Results: A systematic review of the literature demonstrated that cervical discography plays a significant role in selecting surgical candidates and improving outcomes, despite concerns regarding the false-positive rate, lack of standardization, and assorted potential confounding factors. Based on the studies utilizing the International Association for the Study of Pain (IASP) criteria, the data show a prevalence rate ranging between 16% and 20%. Based on the 3 studies that utilized IASP criteria during the performance of cervical discography, the evidence derived from studies evaluating the diagnostic validity of the procedure, the indicated level of evidence is Level II-2 based on modified U.S. Preventive Services Task Force (USPSTF) criteria.

Limitations: Limitations include a paucity of literature, poor methodologic quality, and very few studies performed utilizing IASP criteria.

Conclusion: Cervical discography performed according to the IASP criteria may be a useful tool for evaluating chronic cervical pain, without disc herniation or radiculitis. Based on a modified AHRQ accuracy evaluation and USPSTF level of evidence criteria, this systematic review indicates the strength of evidence as Level II-2 for diagnostic accuracy of cervical discography.
View Article and Find Full Text PDF

Download full-text PDF

Source
July 2009
-->