68 results on '"Amol, Soin"'
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2. Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety
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Alaa Abd-Elsayed, Shalini Shah, David Kloth, Andrea M. Trescot, Aaron K. Calodney, Nikita Shirsat, Standiford Helm, and Amol Soin
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medicine.medical_specialty ,Cluster headache ,business.industry ,Pelvic pain ,Pain medicine ,Chronic pain ,Review ,Neuropathic pain ,medicine.disease ,Neuromodulation (medicine) ,Neuropathy ,law.invention ,Anesthesiology and Pain Medicine ,Randomized controlled trial ,law ,Peripheral nerve stimulation ,Peripheral nerve injury ,medicine ,Physical therapy ,Neurology (clinical) ,medicine.symptom ,business - Abstract
Peripheral nerve stimulation (PNS) was the first application of neuromodulation. Widespread application of PNS was limited by technical concerns. Recent advances now allow the percutaneous placement of leads with ultrasound or fluoroscopic guidance, while the transcutaneous powering of these leads removes the need for leads to cross major joints. This systematic review was written to assess the current status of high-quality evidence supporting the use of PNS for pain conditions treated by interventional pain physicians. The available literature on PNS, limited to conditions treated by interventional pain physicians, was reviewed and the quality assessed. Literature from 1966 to June 2021 was reviewed. The outcome measures were pain relief and functional improvement. One hundred and two studies were identified. Five randomized controlled trials (RCT) and four observational studies, all case series, met the inclusion criteria. One RCT was of high quality and four were of moderate quality; all four case series were of moderate quality. Three of the RCTs and all four case series evaluated peripheral nerve neuropathic pain. Based upon these studies, there is level II evidence supporting the use of PNS to treat refractory peripheral nerve injury. One moderate-quality RCT evaluated tibial nerve stimulation for pelvic pain, providing level III evidence for this indication. One moderate-quality RCT evaluated surgically placed cylindrical leads for cluster headaches, providing level III evidence for this indication. The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief. Adverse events from PNS are generally minor. A major advantage of PNS over spinal cord stimulation is the absence of any risk of central cord injury. The study was limited by the paucity of literature for some indications. No studies dealt with joint-related osteoarthritic pain. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-021-00306-4.
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- 2021
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3. A Systematic Review and Meta-analysis of the Effectiveness of Radiofrequency Neurotomy in Managing Chronic Neck Pain
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Laxmaiah Manchikanti, Nebojsa Nick Knezevic, Emilija Knezevic, Salahadin Abdi, Mahendra R. Sanapati, Amol Soin, Bradley W. Wargo, Annu Navani, Sairam Atluri, Christopher G. Gharibo, Thomas T. Simopoulos, Radomir Kosanovic, Alaa Abd-Elsayed, Alan D. Kaye, and Joshua A. Hirsch
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Anesthesiology and Pain Medicine ,Neurology (clinical) - Abstract
Extensive research into potential sources of neck pain and referred pain into the upper extremities and head has shown that the cervical facet joints can be a potential pain source confirmed by precision, diagnostic blocks.Systematic review and meta-analysis utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, quality assessment of the included studies, conventional and single-arm meta-analysis, and best evidence synthesis.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of radiofrequency neurotomy as a therapeutic cervical facet joint intervention in managing chronic neck pain.Available literature was included. Methodologic quality assessment of studies was performed from 1996 to September 2021. The level of evidence of effectiveness was determined.Based on the qualitative and quantitative analysis with single-arm meta-analysis and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system of appraisal, with inclusion of one randomized controlled trial (RCT) of 12 patients in the treatment group and eight positive observational studies with inclusion of 589 patients showing positive outcomes with moderate to high clinical applicability, the evidence is level II in managing neck pain with cervical radiofrequency neurotomy. The evidence for managing cervicogenic headache was level III to IV with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 15 patients in the treatment group in a positive RCT and 134 patients in observational studies. An overwhelming majority of the studies produced multiple lesions.There was a paucity of literature and heterogeneity among the available studies.This systematic review and meta-analysis shows level II evidence with radiofrequency neurotomy on a long-term basis in managing chronic neck pain with level III to IV evidence in managing cervicogenic headaches.The online version contains supplementary material available at 10.1007/s40122-022-00455-0.
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- 2022
4. An Observational Study on the Use of a Patient Navigator to Help Improve Outcomes in Patients on Chronic Opioids
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Amol, Soin, David, Barrall, Joe, Chen, Anu, Patel, Ann, Pollack, and Amos, Wangombe
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Analgesics, Opioid ,Humans ,Patient Navigation ,Prospective Studies ,Chronic Pain ,Practice Patterns, Physicians' ,Opioid-Related Disorders ,United States ,Retrospective Studies - Abstract
In the United States, the prevalence of opioid use disorders has increased in recent years along with an attendant rise in the incidence of chronic pain disorders and prescription opioid use. Patient navigation services have been used to improve health outcomes in cancer and other chronic disease states, but it is unclear whether the implementation of patient navigation services can facilitate improved outcomes among patients receiving chronic opioid therapy.The objective of this study was to compare the outcomes of patients receiving chronic opioid therapy plus patient navigation services and those receiving chronic opioid therapy as a part of usual care.This was a prospective, observational study. Consecutive patients receiving chronic opioid therapy were enrolled, with alternating assignments to patient navigation (n = 30) or usual care (n = 30). Participants in the patient navigation group received support from a non-physician, non-advanced practice provider staff member who initiated frequent contact via telephone, telemedicine, or in-clinic visits to discuss the patient's health goals. The minimum follow-up period was 90 days. Outcomes qualitatively compared across groups included final pain score, final morphine milligram equivalent (MME) per day, and discharge rates. Risk factors for discharge within the navigation group were assessed. Patient feedback was also solicited.This study was conducted at a single independent pain clinic in the United States.Demographic features were similar between the navigator group and the control group. The control group had a higher average initial pain score (7.0/10) than the intervention group (5.9/10) and were receiving a higher initial dose of opioids (23.1 vs 19.0 MME/d). After an average follow-up of 108.7 days, patients in the navigator group had a 16% decrease in final opioid dose compared with a 23% increase in the control group. Furthermore, patients in the control group were discharged from the practice at a higher rate (23.3% vs 6.6%), suggesting increased opioid misuse in the control group compared with the navigator group. In the navigator group, higher levels of anxiety and depression were the primary predictors of discharge.This was a single-center study with a small sample size. The generalizability of these results to other clinic settings is unknown.Patient navigation decreased opioid use and practice discharge compared with usual care in an independent pain clinic, suggesting a role for patient navigation in reducing opioid misuse and potentially reducing adverse events.
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- 2022
5. Response to: Reply to Sayeed et al
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Yusef, Sayeed, Richard G, Chang, Akhil, Chhatre, Jayesh, Vallabh, Amol, Soin, William D, Mauck, Belinda S, Duszynski, and D Scott, Kreiner
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- 2022
6. 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
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Laxmaiah, Manchikanti, Vidyasagar, Pampati, Mahendra R, Sanapati, Radomir, Kosanovic, Douglas P, Beall, Sairam, Atluri, Salahadin, Abdi, Shalini, Shah, Mark V, Boswell, Alan D, Kaye, Amol, Soin, Christopher G, Gharibo, Bradley W, Wargo, and Joshua A, Hirsch
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COVID-19 ,Humans ,Pain Management ,Chronic Pain ,Medicare ,Pandemics ,United States ,Aged ,Retrospective Studies - Abstract
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.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.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.The data for the analysis was obtained from the master database from the Centers for MedicareMedicaid Services (CMS) physician/supplier procedure summary from 2000 to 2020.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.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.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.
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- 2022
7. Impact Of COVID-19 Pandemic and Updated Utilization Patterns of Sacroiliac Joint Injections from 2000 to 2020 in The Fee-For-Service (FFS) Medicare Population
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Laxmaiah, Manchikanti, Thomas T, Simopoulos, Vidyasagar, Pampati, Maanasa V, Manchikanti, Radomir, Kosanovic, Salahadin, Abdi, Mahendra R, Sanapati, Dhanalakshmi, Koyyalagunta, Nebojsa Nick, Knezevic, Douglas P, Beall, Amol, Soin, Alan D, Kaye, Alaa, Abd-Elsayed, and Joshua A, Hirsch
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COVID-19 ,Humans ,Pain Management ,Sacroiliac Joint ,Chronic Pain ,Medicare ,Pandemics ,United States ,Aged ,Injections, Intra-Articular ,Retrospective Studies - Abstract
Among the multiple causes of low back and lower extremity pain, sacroiliac joint pain has shown to be prevalent in 10% to 25% of patients with persistent axial low back pain without disc herniation, discogenic pain, or radiculitis. Over the years, multiple Current Procedural Terminology (CPT) codes have evolved with the inclusion of intraarticular injections, nerve blocks, and radiofrequency neurotomy, in addition to percutaneous sacroiliac joint fusions. Previous assessments of utilization patterns of sacroiliac joint interventions only included sacroiliac joint intraarticular injections, since the data was not available prior to the introduction of new codes. A recent assessment revealed an increase of 11.3%, and an annual increase of 1.2% per 100,000 Medicare population from 2009 to 2018, showing a decline in growth patterns. During the past 2 years, the COVID-19 pandemic has also had significant effects on the utilization patterns of sacroiliac joint interventions.The impact of the COVID-19 pandemic and analysis of growth patterns of sacroiliac joint interventions (intraarticular injections, nerve blocks, radiofrequency neurotomy, arthrodesis and fusion) was evaluated from 2010 to 2019 and 2010 to 2020, with a comparative analysis from 2019 to 2020 to assess the impact of the COVID-19 pandemic.To update utilization patterns of sacroiliac joint interventions with assessment of the impact of the COVID-19 pandemic.The Centers for Medicare and Medicaid Services (CMS) Physician/Supplier Procedure Summary (PSPS) Master dataset was utilized in the present analysis.The results of this evaluation demonstrated a significant impact of the COVID-19 pandemic with a 19.2% decrease of utilization of sacroiliac joint intraarticular injections from 2019 to 2020. There was a 23.3% increase in sacroiliac joint arthrodesis and a 5.3% decrease for sacroiliac joint fusions with small numbers from 2019 to 2020. However, data was not available for sacroiliac joint nerve blocks and sacroiliac joint radiofrequency neurotomy as these codes were incorporated in 2020. Overall, from 2010 to 2019, sacroiliac joint intraarticular injections showed an annual increase of 0.9% per 100,000 Medicare population. Sacroiliac joint arthrodesis and fusion showed an annual increase from 2010 to 2020 per 100,000 Medicare population of 29% for arthrodesis and 13.3% for fusion.Limitations of this study include a lack of inclusion of Medicare Advantage patients constituting approximately 30% to 40% of the overall Medicare population. As with all claims-based data analyses, this study is retrospective and thus potentially limited by bias. Finally, patients who are non-Medicare are not part of the dataset.The study shows the impact of the COVID-19 pandemic with a significant decrease of intraarticular injections of 19.2% from 2019 to 2020 per 100,000 Medicare population. These decreases of intraarticular injections are accompanied by a 5.3% decrease of fusion, but a 23.3% increase of arthrodesis from 2019 to 2020 per 100,000 Medicare population. Overall, the results showed an annual increase of 0.9% per 100,000 Medicare population for intraarticular injections, a 35.4% annual increase for sacroiliac joint arthrodesis and an increase of 15.5% for sacroiliac joint fusion from 2010 to 2019.
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- 2022
8. Low Back Pain and Diagnostic Lumbar Facet Joint Nerve Blocks: Assessment of Prevalence, FalsePositive Rates, and a Philosophical Paradigm Shift from an Acute to a Chronic Pain Model
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Vidyasagar Pampati, Alan D. Kaye, Joshua A Hirsch, Laxmaiah Manchikanti, Amol Soin, Radomir Kosanovic, and Kimberly A Cash
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Bupivacaine ,Lidocaine ,business.industry ,Local anesthetic ,medicine.drug_class ,Chronic pain ,Retrospective cohort study ,medicine.disease ,Low back pain ,Anesthesiology and Pain Medicine ,Lumbar ,Anesthesia ,Medicine ,Interventional pain management ,medicine.symptom ,business ,medicine.drug - Abstract
Background: Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks. Objective: To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model. Study Design: Retrospective study to determine diagnostic accuracy, prevalence and falsepositive rates. Setting: A multidisciplinary, non-university based interventional pain management practice in the United States. Methods: Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with ≥ 80% pain relief for their ability to perform previously painful movements. Results: The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief ≥ 80% was 6 days with lidocaine block and total relief of ≥ 50% of 32 days. With bupivacaine, the average duration of pain relief ≥ 80% was 13 days with total relief of ≥ 50% lasting for 55 days. Conclusion: This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%. Key words: Chronic spinal pain, lumbar facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, prevalence, false-positive rate
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- 2020
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9. Triaging Interventional Pain Procedures During COVID-19 or Related Elective Surgery Restrictions: Evidence-Informed Guidance from the American Society of Interventional Pain Physicians (ASIPP)
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Devi E. Nampiaparampil, Sudhir Diwan, Steve M. Aydin, Salahadin Abdi, Ricardo M. Buenaventura, Bradley W. Wargo, Mahendra R Sanapati, Shalini Shah, Sukdeb Datta, Harold Cordner, Kenneth D. Candido, Alaa Abd-Elsayed, Amit Sharma, Laxmaiah Manchikanti, Nebojsa Nick Knezevic, Sachin Sunny Jha, Sanjay Bakshi, Christopher Gharibo, Alan D. Kaye, Sairam Atluri, Amol Soin, Joshua A Hirsch, and Kartic Rajput
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medicine.medical_specialty ,Pneumonia, Viral ,Betacoronavirus ,03 medical and health sciences ,0302 clinical medicine ,030202 anesthesiology ,medicine ,Humans ,Pain Management ,Elective surgery ,Intensive care medicine ,Pandemics ,SARS-CoV-2 ,Pain and suffering ,business.industry ,Chronic pain ,COVID-19 ,medicine.disease ,Triage ,United States ,Community hospital ,Anesthesiology and Pain Medicine ,Elective Surgical Procedures ,Private practice ,Chronic Pain ,Interventional pain management ,Coronavirus Infections ,Elective Surgical Procedure ,business - Abstract
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 emergent, urgent, and elective procedures. Examples of emergent and urgent 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, urgent 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. Key words: Coronavirus, COVID-19, interventional pain management, COVID risk factors, elective surgeries, interventional techniques, chronic pain, immunosuppression
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- 2020
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10. The Effect of COVID-19 on Interventional Pain Management Practices: A Physician Burnout Survey
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Michael David Calderon, Shalini Shah, Sachin Sunny Jha, Amol Soin, and Laxmaiah Manchikanti
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medicine.medical_specialty ,Pain medicine ,Pneumonia, Viral ,Burnout ,Job Satisfaction ,Betacoronavirus ,03 medical and health sciences ,0302 clinical medicine ,030202 anesthesiology ,Physicians ,Surveys and Questionnaires ,Health care ,Humans ,Pain Management ,Medicine ,Emotional exhaustion ,Burnout, Professional ,Pandemics ,Depression (differential diagnoses) ,SARS-CoV-2 ,business.industry ,Medical record ,Stressor ,COVID-19 ,Middle Aged ,United States ,Anesthesiology and Pain Medicine ,Family medicine ,Interventional pain management ,Coronavirus Infections ,business ,Stress, Psychological - Abstract
Background: Burnout has been a commonly discussed issue for the past ten years among physicians and other health care workers. A survey of interventional pain physicians published in 2016 reported high levels of emotional exhaustion, often considered the most taxing aspect of burnout. Job dissatisfaction appeared to be the leading agent in the development of burnout in pain medicine physicians in the United States. The COVID-19 pandemic has drastically affected the entire health care workforce and interventional pain management, with other surgical specialties, has been affected significantly. The COVID-19 pandemic has placed several physical and emotional stressors on interventional pain management physicians and this may lead to increased physician burnout. Objective: To assess the presence of burnout specific to COVID-19 pandemic among practicing interventional pain physicians. Methods: American Society of Interventional Pain Physicians (ASIPP) administered a 32 question survey to their members by contacting them via commercially available online marketing company platform. The survey was completed on www.constantcontact.com. Results: Of 179 surveys sent, 100 responses were obtained. The data from the survey demonstrated that 98% of physician practices were affected by COVID and 91% of physicians felt it had a significant financial impact. Sixty seven percent of the physicians responded that inhouse billing was responsible for their increased level of burnout, whereas 73% responded that electronic medical records (EMRs) were one of the causes. Overall, 78% were very concerned. Almost all respondents have been affected with a reduction in interventional procedures. 60% had a negative opinion about the future of their practice, whereas 66% were negative about the entire health care industry. Limitations: The survey included only a small number of member physicians. Consequently, it may not be generalized for other specialties or even pain medicine. However, it does represent the sentiment and present status of interventional pain management. Conclusion: The COVID-19 pandemic has put interventional pain practices throughout the United States under considerable financial and psychological stress. It is essential to quantify the extent of economic loss, offer strategies to actively manage provider practice/wellbeing, and minimize risk to personnel to keep patients safe. Key Words: Interventional pain management, burnout, interventional pain physician, corona COVID-19, financial stress, anxiety, depression
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- 2020
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11. Lack of Superiority of Epidural Injections with Lidocaine with Steroids Compared to Without Steroids in Spinal Pain: A Systematic Review and Meta-Analysis
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Brahma Prasad Vangala, Nebojsa Nick Knezevic, Rachana Vanaparthy, Shalini Shah, Amit Mahajan, Joshua A Hirsch, Vwaire Orhurhu, Laxmaiah Manchikanti, Sairam Atluri, Mahendra R Sanapati, Ivan Urits, Amol Soin, and Alan D. Kaye
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Lidocaine ,Spinal stenosis ,medicine.drug_class ,Anti-Inflammatory Agents ,Injections, Epidural ,Cochrane Library ,law.invention ,Randomized controlled trial ,Adrenal Cortex Hormones ,law ,medicine ,Humans ,Pain Management ,Anesthetics, Local ,Local anesthetic ,business.industry ,Reproducibility of Results ,medicine.disease ,Low back pain ,Anesthesiology and Pain Medicine ,Systematic review ,Anesthesia ,Interventional pain management ,medicine.symptom ,business ,Low Back Pain ,medicine.drug - Abstract
Background: Multiple randomized controlled trials (RCTs) and systematic reviews have been conducted to summarize the evidence for administration of local anesthetic (lidocaine) alone or with steroids, with discordant opinions, more in favor of equal effect with local anesthetic alone or with steroids. Objective: To evaluate the comparative effectiveness of lidocaine alone and lidocaine with steroids in managing spinal pain to assess superiority or equivalency. Study Design: A systematic review of RCTs assessing the effectiveness of lidocaine alone compared with addition of steroids to lidocaine in managing spinal pain secondary to multiple causes (disc herniation, radiculitis, discogenic pain, spinal stenosis, and post-surgery syndrome). Methods: This systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) for literature search, Cochrane review criteria, and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) to assess the methodologic quality assessment and qualitative analysis utilizing best evidence synthesis principles, and quantitative analysis utilizing conventional and single-arm meta-analysis. PubMed, Cochrane Library, US National Guideline Clearinghouse, Google Scholar, and prior systematic reviews and reference lists were utilized in the literature search from 1966 through December 2019. The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Outcome Measures: A hard endpoint for the primary outcome was defined as the proportion of patients with 50% pain relief and improvement in function. Secondary outcome measures, or soft endpoints, were pain relief and/or improvement in function. Effectiveness was determined as short-term if it was less than 6 months. Improvement that lasted longer than 6 months, was defined as long-term. Results: Based on search criteria, 15 manuscripts were identified and considered for inclusion for qualitative analysis, quantitative analysis with conventional meta-analysis, and single-arm meta-analysis. The results showed Level II, moderate evidence, for short-term and long-term improvement in pain and function with the application of epidural injections with local anesthetic with or without steroid in managing spinal pain of multiple origins. Limitations: Despite 15 RCTs, evidence may still be considered as less than optimal and further studies are recommended. Conclusion: Overall, the present meta-analysis shows moderate (Level II) evidence for epidural injections with lidocaine with or without steroids in managing spinal pain secondary to disc herniation, spinal stenosis, discogenic pain, and post-surgery syndrome based on relevant, high-quality RCTs. Results were similar for lidocaine, with or without steroids. Key Words: Chronic spinal pain, epidural injections, local anesthetic, lidocaine, steroids, active control trials, placebo effect
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- 2020
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12. The Technological Impact of COVID-19 on the Future of Education and Health Care Delivery
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Christopher Gharibo, Lynn Kohan, Amol Soin, Sudhir Diwan, David A. Provenzano, Shalini Shah, David Rosenblum, Quinn Nguyen, and Adrian Sulindro
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Adult ,Male ,Telemedicine ,Pneumonia, Viral ,Psychological intervention ,Specialty ,Telehealth ,Betacoronavirus ,03 medical and health sciences ,0302 clinical medicine ,Continuing medical education ,030202 anesthesiology ,Informed consent ,Humans ,Medicine ,Fellowships and Scholarships ,Pandemics ,Accreditation ,Medical education ,SARS-CoV-2 ,business.industry ,COVID-19 ,Internship and Residency ,Online counseling ,Anesthesiology and Pain Medicine ,Education, Medical, Graduate ,Coronavirus Infections ,business ,Delivery of Health Care - Abstract
Background: The unexpected COVID-19 crisis has disrupted medical education and patient care in unprecedented ways. Despite the challenges, the health-care system and patients have been both creative and resilient in finding robust “temporary” solutions to these challenges. It is not clear if some of these COVID-era transitional steps will be preserved in the future of medical education and telemedicine. Objectives: The goal of this commentary is to address the sometimes substantial changes in medical education, continuing medical education (CME) activities, residency and fellowship programs, specialty society meetings, and telemedicine, and to consider the value of some of these profound shifts to “business as usual” in the health-care sector. Methods: This is a commentary is based on the limited available literature, online information, and the front-line experiences of the authors. Results: COVID-19 has clearly changed residency and fellowship programs by limiting the amount of hands-on time physicians could spend with patients. Accreditation Council for Graduate Medicine Education has endorsed certain policy changes to promote greater flexibility in programs but still rigorously upholds specific standards. Technological interventions such as telemedicine visits with patients, virtual meetings with colleagues, and online interviews have been introduced, and many trainees are “technoomnivores” who are comfortable using a variety of technology platforms and techniques. Webinars and e-learning are gaining traction now, and their use, practicality, and cost-effectiveness may make them important in the post-COVID era. CME activities have migrated increasingly to virtual events and online programs, a trend that may also continue due to its practicality and cost-effectiveness. While many medical meetings of specialty societies have been postponed or cancelled altogether, technology allows for virtual meetings that may offer versatility and time-saving opportunities for busy clinicians. It may be that future medical meetings embrace a hybrid approach of blending digital with face-toface experience. Telemedicine was already in place prior to the COVID-19 crisis but barriers are rapidly coming down to its widespread use and patients seem to embrace this, even as health-care systems navigate the complicated issues of cybersecurity and patient privacy. Regulatory guidance may be needed to develop safe, secure, and patient-friendly telehealth applications. Telemedicine has affected the prescribing of controlled substances in which online counseling, informed consent, and follow-up must be done in a virtual setting. For example, pill counts can be done in a video call and patients can still get questions answered about their pain therapy, although it is likely that after the crisis, prescribing controlled substances may revert to face-to-face visits. Limitations: The health-care system finds itself in a very fluid situation at the time this was written and changes are still occurring and being assessed. Conclusions: Many of the technological changes imposed so abruptly on the health-care system by the COVID-19 pandemic may be positive and it may be beneficial that some of these transitions be preserved or modified as we move forward. Clinicians must be objective in assessing these changes and retaining those changes that clearly improve health-care education and patient care as we enter the COVID era. Key words: Continuing medical education, COVID-19, fellowship program, medical education, medical meetings, residency program, telehealth, telemedicine
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- 2020
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13. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines
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Bradley W. Wargo, Sheri L. Albers, Annu Navani, Christopher Gharibo, Vidyasagar Pampati, Gururau Sudarshan, Ramarao Pasupuleti, Laxmaiah Manchikanti, Joshua A Hirsch, Kenneth D. Candido, Lynn Cintron, Jessica Jameson, Mahendra R Sanapati, Sudhir Diwan, Rachana Vanaparthy, Jay S. Grider, Mark V. Boswell, Alan D. Kaye, Douglas P. Beall, Amol Soin, Kartic Rajput, Paul J. Christo, Cyril Philip, Bill Haney, Gabor B. Racz, Nalini Sehgal, Standiford Helm, Alaa Abd-Elsayed, Shalini Shah, Richard E. Latchaw, Sairam Atluri, Myank Gupta, Radomir Kosanovic, Sanjay Bakshi, Aaron K. Calodney, Michael E. Harned, Salahadin Abdi, Steve M. Aydin, Sunny Jha, Nebojsa Nick Knezevic, Ricardo M. Buenaventura, Joseph A Cabaret, Adam M. Kaye, and Maanasa V Manchikanti
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musculoskeletal diseases ,medicine.medical_specialty ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Evidence-based practice ,business.industry ,medicine ,Psychological intervention ,Physical therapy ,business ,Spinal pain ,Facet joint - Abstract
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.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 interventions 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
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- 2020
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14. Trends of Expenditures and Utilization of Facet Joint Interventions in Fee-For-Service (FFS) Medicare Population from 2009-2018
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Joshua A Hirsch, Vidyasagar Pampati, Amol Soin, Mahendra R Sanapati, Rachana Vanaparthy, Alan D. Kaye, and Laxmaiah Manchikanti
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musculoskeletal diseases ,Total cost ,business.industry ,Psychological intervention ,Medicare Advantage ,Facet joint ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Medicare population ,Medicine ,Fee-for-service ,business ,Medicaid ,health care economics and organizations ,Neurolysis ,Demography - Abstract
Background: The trends of the expenditures of facet joint interventions have not been specifically assessed in the fee-for-service (FFS) Medicare population since 2009 Objectives: The objective of this investigation is to assess trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009 to 2018. Study Design: The study was designed to analyze trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009-2018 in the United States. In this manuscript: • A patient was considered as undergoing facet joint interventions throughout the year. • A visit included all regions treated during the visit. • An episode was considered as one per region utilizing primary codes only. • Services or procedures were considered all procedures (multiple levels). Data for the analysis was obtained from the standard 5% national sample of the Centers for Medicare & Medicaid Services (CMS) physician outpatient billing claims for those enrolled in the FFS Medicare program from 2009 to 2018. All the expenditures were presented with allowed costs and also were inflation adjusted to 2018 US dollars. Results: This analysis showed expenditures increased by 79% from 2009 to 2018 in the form of total cost for facet joint interventions, at an annual rate of 6.7%. Cervical and lumbar radiofrequency neurotomy procedures increased 185% and 169%. However, inflation-adjusted expenditures with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. In addition, using inflation-adjusted expenditures per procedures increased, the overall 6% with an annual increase of 0.7%. Overall, per patient costs, with inflation adjustment, decreased from $1,925 to $1,785 with a decline of 7% and an annual decline of 0.8%. Allowed charges per visit also declined after inflation adjustment from $951.76 to $849.86 with an overall decline of 11% and an annual decline of 1.3%. Staged episodes of radiofrequency neurotomy were performed in 23.9% of patients and more than 2 episodes for radiofrequency neurotomy in 6.9%, in lumbar spine and 19.6% staged and 5.1% more than 2 episodes in cervical spine of patients in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. Conclusions: Even after adjusting for inflation, there was a significant increase for the expenditures of facet joint interventions with an overall 53% increase. Costs per patient and cost per visit declined. Inflation-adjusted cost per year declined 7% overall and 0.8% annually from $1,925 to $1,785, and inflation-adjusted cost per visit also declined 11% annually and 1.3% per year from $952 in 2009 to $850 in 2018. Key words: Facet joint interventions, facet joint nerve blocks, facet joint neurolysis, facet joint injections, Medicare expenditures
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- 2020
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15. Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)
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Kenneth Mautner, Matthew Lucas, Ian Stemper, Shane A. Shapiro, Joshua A Hirsch, Christopher Gharibo, Maanasa V Manchikanti, Kenneth D. Candido, Theodore Sand, Alaa Abd-Elsayed, Sudhir Diwan, Sarah M. Pastoriza, Michael Fredericson, Ramarao Pasupuleti, Alan D. Kaye, Christopher J. Centeno, Cameron Cartier, Mahendra R Sanapati, Douglas P. Beall, Nebojsa Nick Knezevic, Vidyasagar Pampati, Samuel Murala, Philippe Hernigou, R Amadeus Mason, Steve M. Aydin, Mairin A Jerome, Joanne Borg-Stein, Cyril Philip, Amol Soin, Ricardo M. Buenaventura, Joseph A Cabaret, Gerard A. Malanga, Radomir Kosanovic, Zachary Fausel, Aaron K. Calodney, Rinoo V. Shah, Ehren Dodson, Adam M. Kaye, Laxmaiah Manchikanti, Mayank Gupta, Bradley W. Wargo, Sheri L. Albers, Annu Navani, Don Buford, Richard E. Latchaw, and Sairam Atluri
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medicine.medical_specialty ,Evidence-based practice ,business.industry ,MEDLINE ,Investigational New Drug ,Evidence-based medicine ,law.invention ,Transplantation ,Anesthesiology and Pain Medicine ,Systematic review ,Randomized controlled trial ,law ,medicine ,Intensive care medicine ,business ,Evidence-based policy - Abstract
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.
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- 2020
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16. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population
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Joysree Subramanian, Alan D. Kaye, Mahendra R Sanapati, Joshua A Hirsch, Vidyasagar Pampati, Sairam Atluri, Amol Soin, and Laxmaiah Manchikanti
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Male ,musculoskeletal diseases ,medicine.medical_specialty ,Facet (geometry) ,Pain ,Medicare Advantage ,Medicare ,Anesthesia, Spinal ,Neurosurgical Procedures ,Zygapophyseal Joint ,Injections, Intra-Articular ,Facet joint ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Anesthesia, Conduction ,030202 anesthesiology ,medicine ,Humans ,Pain Management ,Fee-for-service ,Neurolysis ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Facet joint injection ,Nerve Block ,Denervation ,United States ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Physical therapy ,Female ,Spinal Diseases ,Chronic Pain ,business ,Medicaid ,Lumbosacral joint - Abstract
Background: Interventional techniques for managing spinal pain, from conservative modalities to surgical interventions, are thought to have been growing rapidly. Interventional techniques take center stage in managing chronic spinal pain. Specifically, facet joint interventions experienced explosive growth rates from 2000 to 2009, with a reversal of these growth patterns and in some settings, a trend of decline after 2009. Objectives: The objectives of this assessment of utilization patterns include providing an update of facet joint interventions in managing chronic spinal pain in the fee-for-service (FFS) Medicare population of the United States from 2000 to 2018. Study Design: The study was designed to assess utilization patterns and variables of facet joint interventions in managing chronic spinal pain from 2000 to 2018 in the FFS Medicare population in the United States. Methods: Data for the analysis were obtained from the master database from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary from 2000 to 2018. Results: Facet joint interventions increased 1.9% annually and 18.8% total from 2009 to 2018 per 100,000 FFS Medicare population compared with an annual increase of 17% and overall increase of 309.9% from 2000 to 2009. Lumbosacral facet joint nerve block sessions or visits decreased at an annual rate of 0.2% from 2009 to 2018, with an increase of 15.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis sessions increased at an annual rate of 7.4% from 2009 to 2018, and the utilization rate also increased at an annual rate of 23.0% from 2000 to 2009. The proportion of lumbar facet joint blocks sessions to lumbosacral facet joint neurolysis sessions changed from 6.7 in 2000 to 1.9 in 2018. Cervical and thoracic facet joint injections increased at an annual rate of 0.5% compared with cervicothoracic facet neurolysis sessions of 8.7% from 2009 to 2018. Cervical facet joint injections increased to 4.9% from 2009 to 2018 compared with neurolysis procedures of 112%. The proportion of cervical facet joint injection sessions to neurolysis sessions changed from 8.9 in 2000 to 2.4 in 2018. Limitations: This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. The utilization data for individual states also continues to be sparse and may not be accurate. Conclusions: Utilization patterns of facet joint interventions increased 1.9% per 100,000 Medicare population from 2009 to 2018. This results from an annual decline of - 0.2% lumbar facet joint injection sessions but with an increase of facet joint radiofrequency sessions of 7.4%. Key words: Interventional techniques, facet joint interventions, facet joint nerve blocks, facet joint neurolysis
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- 2020
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17. An Updated Analysis of Utilization of Epidural Procedures in Managing Chronic Pain in the Medicare Population from 2000 to 2018
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Vidyasagar Pampati, Vanila Singh, Maanasa V Manchikanti, Mahendra R Sanapati, Amol Soin, Joshua A Hirsch, and Laxmaiah Manchikanti
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Neck pain ,education.field_of_study ,business.industry ,Population ,Chronic pain ,Strengthening the reporting of observational studies in epidemiology ,Medicare Advantage ,medicine.disease ,Anesthesiology and Pain Medicine ,Lumbar ,Anesthesia ,Medicare population ,Medicine ,Observational study ,medicine.symptom ,business ,education - Abstract
Background: With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures. Objectives: The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-forservice (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018. Study Design: Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States. Methods: This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results: Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals. Limitations: This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population. Conclusions: The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections. Key words: Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns
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- 2020
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18. Fourth Wave of Opioid (Illicit Drug) Overdose Deaths and Diminishing Access to Prescription Opioids and Interventional Techniques: Cause and Effect
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Laxmaiah, Manchikanti, Vanila Mathur, Singh, Peter S, Staats, Andrea M, Trescot, John, Prunskis, Nebojsa Nick, Knezevic, Amol, Soin, Alan D, Kaye, Sairam, Atluri, Mark V, Boswell, Alaa, Abd-Elsayed, and Joshua A, Hirsch
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Analgesics, Opioid ,Prescriptions ,Illicit Drugs ,COVID-19 ,Humans ,Pandemics - Abstract
In the midst of the COVID-19 pandemic, data has shown that age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, and heroin have been increasing, including prescription opioid deaths, which were declining, but, recently, reversing the trends. Contrary to widely held perceptions, the problem of misuse, abuse, and diversion of prescription opioids has been the least of all the factors in recent years. Consequently, it is important to properly distinguish between the role of illicit and prescription opioids in the current opioid crisis. Multiple efforts have been based on consensus on administrative policies for certain harm reduction strategies for individuals actively using illicit drugs and reducing opioid prescriptions leading to curbing of medically needed opioids, which have been ineffective. While there is no denial that prescription opioids can be misused, abused, and diverted, the policies have oversimplified the issue by curbing prescription opioids and the pendulum has swung too far in the direction of severely limiting prescription opioids, without acknowledgement that opioids have legitimate uses for persons suffering from chronic pain. Similar to the opioid crisis, interventional pain management procedures have been affected by various policies being applied to reduce overuse, abuse, and finally utilization. Medical policies have been becoming more restrictive with reduction of access to certain procedures, with the pendulum swinging too far in the direction of limiting interventional techniques. Recent utilization assessments have shown a consistent decline for most interventional techniques, with a 18.7% decrease from 2019 to 2020. The causes for these dynamic changes are multifactorial likely including the misapplication of the 2016 Centers for Disease Control and Prevention (CDC) guidelines for prescribing opioids for chronic pain, the relative ease of access to illicit synthetic opioids and more recently issues related to the COVID-19 pandemic. In addition, recent publications have shown association of dose tapering with overdose or mental health crisis among patients prescribed long-term opioids. These findings are leading to the hypothesis that federal guidelines may inadvertently be contributing to an increase in overall opioid deaths and diminished access to interventional techniques. Together, these have resulted in a fourth wave of the opioid epidemic.A narrative review.The fourth wave results from a confluence of multiple factors, including misapplication of CDC guidelines, the increased availability of illicit drugs, the COVID-19 pandemic, and policies reducing access to interventional procedures. The CDC guidelines and subsequent regulatory atmosphere have led to aggressive tapering up to and including, at times, the overall reduction or stoppage of opioid prescriptions. Forced tapering has been linked to an increase of 69% for overdoses and 130% for mental health crisis. The data thus suggests that the diminution in access to opioid prescriptions may be occurring simultaneously with an increase in illicit narcotic use.Combined with CDC guidelines, the curbing of opioid prescriptions to medically needed individuals, among non-opioid treatments, interventional techniques have been affected with declining utilization rates and medical policies reducing access to such modalities.The opioid overdose waves over the past three decades have resulted from different etiologies. Wave one was associated with prescription opioid overdose deaths and wave two with the rise in heroin and overdose deaths from 1999 to 2013. Wave three was associated with a rise in synthetic opioid overdose deaths. Sadly, wave four continues to escalate with increasing number of deaths as a confluence of factors including the CDC guidelines, the COVID pandemic, increased availability of illicit synthetic opioids and the reduction of access to interventional techniques, which leads patients to seek remedies on their own.
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- 2022
19. A Pilot Study Implementing a Machine Learning Algorithm to Use Artificial Intelligence to Diagnose Spinal Conditions
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Amol, Soin, Megan, Hirschbeck, Michael, Verdon, and Laxmaiah, Manchikanti
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Adult ,Aged, 80 and over ,Epidural Space ,Male ,Adolescent ,Pilot Projects ,Middle Aged ,United States ,Machine Learning ,Young Adult ,Artificial Intelligence ,Chronic Disease ,Humans ,Female ,Spinal Diseases ,Prospective Studies ,Chronic Pain ,Algorithms ,Aged - Abstract
Chronic spinal pain is the most prevalent chronic disease, with chronic persistent spinal pain lasting longer than one-year reported in 25% to 60% of the patients. Health care expenditures have been escalating and the financial impact on the US economy is growing. Among multiple modalities of treatments available, facet joint interventions and epidural interventions are the most common ones, in addition to surgical interventions and numerous other conservative modalities of treatments. Despite these increasing costs in the diagnosis and management, disability continues to increase. Consequently, algorithmic approaches have been described as providing a disciplined approach to the use of spinal interventional techniques in managing spinal pain. This approach includes evaluative, diagnostic, and therapeutic approaches, which avoids unnecessary care, as well as poorly documented practices. Recently, techniques involving artificial intelligence and machine learning have been demonstrated to contribute to the improved understanding, diagnosis, and management of both acute and chronic disease in line with well-designed algorithmic approach. The use of artificial intelligence and machine-learning techniques for the diagnosis of spinal pain has not been widely investigated or adopted.To evaluate whether it is possible to use artificial intelligence via machine learning algorithms to analyze specific data points and to predict the most likely diagnosis related to spinal pain.This was a prospective, observational pilot study.A single pain management center in the United States.A total of 246 consecutive patients with spinal pain were enrolled. Patients were given an iPad to complete a Google form with 85 specific data points, including demographic information, type of pain, pain score, pain location, pain duration, and functional status scores. The data were then input into a decision tree machine learning software program that attempted to learn which data points were most likely to correspond to the practitioner-assigned diagnosis. These outcomes were then compared with the practitioner-assigned diagnosis in the chart.The average age of the included patients was 57.4 years (range, 18-91 years). The majority of patients were women and the average pain history was approximately 2 years. The most common practitioner-assigned diagnoses included lumbar radiculopathy and lumbar facet disease/spondylosis. Comparison of the software-predicted diagnosis based on reported symptoms with practitioner-assigned diagnosis revealed that the software was accurate approximately 72% of the time.Additional studies are needed to expand the data set, confirm the predictive ability of the data set, and determine whether it is broadly applicable across pain practices.Software-predicted diagnoses based on the data from patients with spinal pain had an accuracy rate of 72%, suggesting promise for augmented decision making using artificial intelligence in this setting.
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- 2022
20. The Impact of COVID-19 on Interventional Pain Management Practices is Significant and Long-Lasting: An Interventional Pain Management Physician Survey
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Laxmaiah, Manchikanti, Vidyasagar, Pampati, Sachin Sunny, Jha, Mahendra R, Sanapati, Amol, Soin, Shalini, Shah, Alan D, Kaye, and Joshua A, Hirsch
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Physicians ,Surveys and Questionnaires ,Communicable Disease Control ,COVID-19 ,Humans ,Pain Management ,Pandemics ,United States - Abstract
As with many others in the house of medicine, the COVID-19 pandemic has adversely impacted the practice of interventional pain management. This in part relates to various state health authority or medical board restrictions with reductions in patient volume for evaluations, follow-ups, and procedures. Of course, the pandemic continues to persist which is in turn leading to longer-lasting effects. Our previous survey was performed in March 2020. At that time, there was a national lockdown in the United States with COVID-19 disease qualifying as a pandemic by the World Health Organization (WHO). The pandemic caused by COVID-19 disease continues to have far-reaching implications on how we deliver routine care to patients and its effect on patient care, economic aspects, and health of interventional pain management providers.To assess the current and expected future impact of the COVID-19 pandemic on interventional pain management practices in a physician survey. The study was performed based on performance in 2021 compared to the 2019 pre-COVID era.The American Society of Interventional Pain Physicians (ASIPP) administered a 16-question survey to their members by contacting them via a commercially available online marketing company platform. The survey was completed on www.constantcontact.com.The results showed that 88% of the providers experienced a reduction in income and a similar number expect decreases over the next 12 months. A large proportion of respondents (73.3%) reported a reduction in revenue of 11%-25%. In contrast, another 21.5% reported a revenue decline of 26%-50%, and 29% reported 11%-25% increase in expenses. Overall, new patient volume decreased 11%-25% based on the response from almost 63%, whereas almost 9% reported a decline of 26%-50%. In contrast, established patient volume declined 1%-10% as reported by 64% of the respondents, compared to an 11%-25% decrease by a small proportion of 14%. All interventional procedures showed significant decreases across the board, with 69% of the respondents reporting a decline in-office procedures, 64% in ambulatory surgery center (ASC) procedures, and 57% in hospital outpatient department (HOPD) procedures, ranging from 11%-25%.The survey included a relatively small number of member physicians which could introduce sampling error. Consequently, it may not be generalizable for other specialties or even to pain medicine.The COVID-19 pandemic has put interventional pain practices throughout the United States under considerable financial and psychological stress. This study seeks to quantify the extent of economic loss and other challenges resultant from the pandemic. Almost 99% reported a decrease in revenues in the last 12 months, with 86% reporting an expected reduction in the next 12 months and 49% reporting an increase in expenses. Declines have been reported in all sectors with new patients, office procedures, ASC, and HOPD procedures, except for established patient visits, which have shown minor declines compared to other domains. Understanding the issues facing interventional pain management physicians facilitates the development of strategies to actively manage provider practice/well-being, and to minimize risk to personnel to keep patients safe.
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- 2022
21. The Analysis of Pain Research through the Lens of Artificial Intelligence and Machine Learning
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Jagadesh N, Nagireddi, Amanya Ketan, Vyas, Mahendra R, Sanapati, Amol, Soin, and Laxmaiah, Manchikanti
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Machine Learning ,Artificial Intelligence ,Infant, Newborn ,Humans ,Pain ,Algorithms ,Forecasting - Abstract
Traditional pain assessment methods have significant limitations due to the high variability in patient reported pain scores and perception of pain by different individuals. There is a need for generalized and automatic pain detection and recognition methods. In this paper, state-of-the-art machine learning (ML) and deep learning methods in this field are analyzed as well as pain management techniques.The objective of the study is to analyze the current use of artificial intelligence (AI) and ML in the analysis and management of pain and to disseminate this knowledge prompting future utilization by medical professionals.A narrative review of the literature focusing on the latest algorithms in AI and ML for pain assessment and management.Research studies were collected using a literature search on PubMed, Science Direct and IEEE Xplore between 2018 and 2020.The results of our assessment resulted in the identification of 47 studies meeting inclusion criteria. Pain assessment was the most studied subject with 11 studies, followed by automated measurements with 10 studies, spinal diagnosis with 8 studies, facial expression with 7 studies, pain assessment in special settings evaluated in 5 studies, 4 studies described treatment algorithms, and 2 studies assessed neonatal pain. These studies varied from simple to highly complex methodology. The majority of the studies suffered from inclusion of a small number of patients and without replication of results. However, considering AI and ML are dynamic and emerging specialties, the results shown here are promising. Consequently, we have described all the available literature in summary formats with commentary. Among the various assessments, facial expression and spinal diagnosis and management appear to be ready for inclusion as we continue to progress.This review is not a systematic review of ML and AI applications in pain research. This review only provides a general idea of the upcoming techniques but does not provide an authoritative evidence-based conclusive opinion of their clinical application and effectiveness.While a majority of the studies focused on classification tasks, very few studies have explored the diagnosis and management of pain. Usage of ML techniques as support tools for clinicians holds an immense potential in the field of pain management.
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- 2022
22. Equivalent Outcomes of Lumbar Therapeutic Facet Joint Nerve Blocks and Radiofrequency Neurotomy: Comparative Evaluation of Clinical Outcomes and Cost Utility
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Laxmaiah, Manchikanti, Radomir, Kosanovic, Vidyasagar, Pampati, Mahendra R, Sanapati, Amol, Soin, Nebojsa Nick, Knezevic, Bradley W, Wargo, and Joshua A, Hirsch
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Treatment Outcome ,Humans ,Nerve Block ,Anesthetics, Local ,Medicare ,Denervation ,Low Back Pain ,United States ,Zygapophyseal Joint ,Aged ,Retrospective Studies - Abstract
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.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.A retrospective, case-control, comparative evaluation of outcomes and cost utility.The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States.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.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.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.
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- 2022
23. Response to: Invasive Treatments for Low Back Disorders and the ACOEM Practice Guidelines
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Yusef Sayeed, Richard G. Chang, Akhil Chhatre, Jayesh Vallabh, Amol Soin, William D. Mauck, Belinda S. Duszynski, and D. Scott Kreiner
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Occupational Medicine ,Public Health, Environmental and Occupational Health ,Humans ,Pain Management - Published
- 2021
24. In Response Comments on 'Low-Dose Naltrexone Use for Patients with Chronic Regional Pain Syndrome: A Systematic Literature Review'
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Amol, Soin, Yasmeen, Soin, Tammy, Dann, Ricardo, Buenaventura, Kris, Ferguson, Sairam, Atluri, Harsh, Sachdeva, Gururau, Sudarshan, Humam, Akbik, and Jordan, Italiano
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Humans ,Chronic Pain ,Naltrexone - Published
- 2021
25. ASIPP Guidelines for Sedation and Fasting Status of Patients Undergoing Interventional Pain Management Procedures
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Alan D. Kaye, Omar Viswanath, Michael E. Harned, Thomas T. Simopoulos, Sukdeb Datta, Amol Soin, Mahendra R Sanapati, Laxmaiah Manchikanti, Mark V. Boswell, Sheri L. Albers, Sudhir Diwan, Kenneth D. Candido, Mark R. Jones, and Frank J E Falco
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business.industry ,Sedation ,Chronic pain ,Perioperative ,medicine.disease ,Hypoventilation ,03 medical and health sciences ,Fasting Status ,0302 clinical medicine ,Anesthesiology and Pain Medicine ,030202 anesthesiology ,Anesthesia ,medicine ,Outpatient clinic ,medicine.symptom ,Interventional pain management ,business ,Spinal cord injury - Abstract
Many of the patients undergoing interventional procedures have daily regimens of medications including analgesics, muscle relaxants, and other drugs that can have significant additive/synergistic effects during the perioperative period. Further, many patients also present with comorbid states, including obesity, cardiovascular, and pulmonary disease. Consequently, in the perioperative period, a significant number of patients have suffered permanent neurologic injury, hypoxic brain injury, and even death as a result of over sedation, hypoventilation, and spinal cord injury. In addition, physicians are concerned about aspiration, subsequent complications, and as a result, they ask patients to fast for several hours prior to the procedures. Based on extensive literature and consensus, a minimum fasting period is established as 2 hours before a procedure for clear liquids and 4 hours before procedure for light meals, rather than having all patients fast for 8 hours or even fasting beginning at midnight the night before the procedure. Gastrointestinal stimulants, gastric acid secretion blockers, and antacids may be used, even though not routinely recommended. Due to the nature of chronic pain and anxiety, many patients undergoing interventional techniques may require mild to moderate sedation. Deep sedation and/or general anesthesia for most interventional procedures is considered as unsafe, since the patient cannot communicate acute changes in symptoms, thus, resulting in morbidity and mortality, as well as creating compliance issues. We are adapting the published standards of the American Society of Anesthesiologists for monitoring patients under sedation, regardless of the location of the procedure, either office-based, in a surgery center, or a hospital outpatient department. These standards include monitoring of blood pressure, cardiac rhythm, temperature, pulse oximetry, and continuous quantitative end tidal CO2 monitoring. Sedation must be provided either by qualified anesthesia or non-anesthesia providers, with appropriate understanding of the medications, drug interactions, and resuscitative protocols. Key words: Guidelines, sedation, fasting status, monitoring, neurological complications
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- 2019
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26. Spinal Cord Stimulation Trends of Utilization and Expenditures in Fee-For-Service (FFS) Medicare Population from 2009 to 2018
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Laxmaiah, Manchikanti, Vidyasagar, Pampati, Brahma Prasad, Vangala, Amol, Soin, Mahendra R, Sanapati, Srinivasa, Thota, and Joshua A, Hirsch
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Spinal Cord Stimulation ,Quality of Life ,Humans ,Pain Management ,Health Expenditures ,Medicare ,United States ,Aged - Abstract
Spinal cord stimulation has been utilized with increasing frequency in managing chronic intractable spinal pain and complex regional pain syndrome (CRPS) in addition to other neuropathic pain states. The literature has shown the effectiveness of spinal cord stimulation in managing chronic pain with improvement in quality of life and cost utility. There have not been any reviews performed in the fee-for-service (FFS) Medicare population in reference to utilization and expenditure patterns of spinal cord stimulators.This investigation was undertaken to assess the utilization and expenditures for spinal cord stimulation in the FFS Medicare population from 2009 to 2018.The present study was designed to assess the utilization patterns and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data. All the expenditures were presented with allowed costs and adjusted to inflation to 2018 US dollars only trials and implants were included.Utilization patterns showed that spinal cord stimulation trials increased from 12,680 in 2009 to 36,280 in 2018, a 186% increase with an annual increase of 12.4%. The rate of trials per 100,000 population increased from 28 in 2009 to 61 in 2018 with a 120% increase, or an annual increase of 9.1%. The pulse generator implants increased from 7,640 in 2009 to 22,960 in 2018, an increase of 201%, with an annual increase of 13%. In addition, percutaneous placement with pulse generator implants increased from 4,080 in 2009 to 14,316 in 2018, a 252% increase, or 15% annual increase. In contrast, implantation of neurostimulator electrodes with paddle leads with laminectomy and placement of spinal pulse generator increased from 3,560 in 2009 to 8,600 in 2018, a 142% increase or an annual increase of 10.3%. Analysis of expenditures showed total inflation-adjusted expenditures increased from $292,153,701 in 2009 to $1,142,434,137 in 2018, a 291% increase from 2009 to 2018 and 16.4% annual increase. These expenditures were 125% higher than facet joint interventions and 138% higher than epidural interventions in 2018. In contrast, these expenditures were 55% below the expenditures of facet joint interventions and 66% lower than epidural injections in 2009.Trial to implant ratio improved from 42.5% in 2009 to 63.6% in 2018. An overwhelming majority of trials (90%) were performed by nonsurgical physicians, whereas, 56% of implants were performed by non-surgeons.This assessment includes only FFS Medicare population, thus eliminating approximately 30% of the population with Medicare Advantage plans. In addition, this study has not taken into consideration various revisions not included in 3 specific codes.The analysis of spinal cord stimulators in the FFS Medicare population from 2009 to 2018 showed explosive increases of trials, implants and overall costs.
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- 2021
27. Low-Dose Naltrexone Use for Patients with Chronic Regional Pain Syndrome: A Systematic Literature Review
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Amol, Soin, Yasmeen, Soin, Tammy, Dann, Ricardo, Buenaventura, Kris, Ferguson, Sairam, Atluri, Harsh, Sachdeva, Gururau, Sudarshan, Humam, Akbik, and Jordan, Italiano
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Fibromyalgia ,Animals ,Humans ,Prospective Studies ,Chronic Pain ,Naltrexone ,United States ,Retrospective Studies - Abstract
Complex regional pain syndrome is a rare, neuropathic disorder that affects fewer than 200,000 individuals in the United States annually. Current treatments often focus on pain management and fall short of relieving symptoms of pain and dystonia in patients.The goal of this systematic qualitative review is to evaluate the evidence for the use of low-dose naltrexone in the treatment of chronic pain syndromes.This is a systematic review.PubMed, Embase, and Web of Science were searched for articles containing the keywords "low-dose naltrexone" AND ("pain" OR "chronic pain" OR "fibromyalgia" OR "complex regional pain syndrome" OR "neuropathic pain" OR "nociceptive pain") between 1950 and July 17, 2020. A total of 30 publications were systematically reviewed. Exclusion criteria were articles that were unavailable in English, focused on acute pain only, and evaluated only animal models. Case studies were included for the purposes of our qualitative review.Out of 29 articles, we reviewed 11 prospective studies, 10 case studies, 3 systematic reviews, 2 retrospective studies, 2 simulation models, and one combination study. Articles focused on chronic pain syndromes as well as painful rheumatologic disorders and neurological disorders. We found that low-dose naltrexone treatment was positively associated with symptom relief in patients experiencing chronic pain, dystonia, and sleep disturbances.Due to the limited number of available articles focusing on the treatment of complex regional pain syndrome with low-dose naltrexone, the majority of studies analyzed focused on other chronic pain syndromes.There is a need for additional prospective and interventional studies addressing the use of low-dose naltrexone in the treatment of complex regional pain syndrome symptoms.
- Published
- 2021
28. Essentials of Interventional Techniques in Managing Chronic Pain
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Vijay Singh, Frank J.E. Falco, Alan D. Kaye, Amol Soin, Joshua A. Hirsch, Vijay Singh, Frank J.E. Falco, Alan D. Kaye, Amol Soin, and Joshua A. Hirsch
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- Anesthesiology, Chronic pain--Treatment, Medical care, Neurology
- Abstract
This comprehensive review covers the full and latest array of interventional techniques for managing chronic pain. Chapters are grouped by specific treatment modalities that include spinal interventional techniques, non-spinal and peripheral nerve blocks, sympathetic interventional techniques, soft tissue and joint injections, and implantables. This second edition features new chapters covering challenges with opioid therapy, impact of COVID-19, and spinal interventional techniques.Practical step-by-step and evidence-based guidance is given to each approach in order to improve the clinician's understanding. Innovative and timely, Essentials of Interventional Techniques in Managing Chronic Pain is a critical resource for anesthesiologists, neurologists, and rehabilitation and pain physicians.
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- 2024
29. Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain
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Laxmaiah, Manchikanti, Sairam, Atluri, Mark V, Boswell, Aaron K, Calodney, Sudhir, Diwan, Sanjeeva, Gupta, Alan D, Kaye, Nebojsa Nick, Knezevic, Kenneth D, Candido, Alaa, Abd-Elsayed, Miguel A, Pappolla, Gabor B, Racz, Harsh, Sachdeva, Mahendra R, Sanapati, Shalini, Shah, Vanila, Singh, Amol, Soin, and Joshua A, Hirsch
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Humans ,Chronic Pain ,Systematic Reviews as Topic - Abstract
The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria.To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain.A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations.Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews.Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques.This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.
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- 2021
30. Declining Utilization and Inflation-Adjusted Expenditures for Epidural Procedures in Chronic Spinal Pain in the Medicare Population
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Laxmaiah, Manchikanti, Vidyasagar, Pampati, Amol, Soin, Mahendra R, Sanapati, Alan D, Kaye, and Joshua A, Hirsch
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Anesthesia, Epidural ,Humans ,Pain Management ,Chronic Pain ,Health Expenditures ,Medicare ,Centers for Medicare and Medicaid Services, U.S ,United States ,Retrospective Studies - Abstract
Despite epidurals being one of the most common interventional pain procedures for managing chronic spinal pain in the United States, expenditure analysis lacks assessment in correlation with utilization patterns.This investigation was undertaken to assess expenditures for epidural procedures in the fee-for-service (FFS) Medicare population from 2009 to 2018.The present study was designed to assess expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. In this manuscript: • A patient was described as receiving epidural procedures throughout the year.• A visit was considered to include all regions treated during the visit. • An episode was considered as one treatment per region utilizing primary codes only.• Services or procedures were considered as all procedures including bilateral and multiple levels. A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data for those enrolled in the FFS Medicare program from 2009 to 2018 was utilized. All the expenditures were presented with allowed costs and adjusted to inflation to 2018 US dollars.Total expenditures were $723,981,594 in 2009, whereas expenditures of 2018 were $829,987,636, with an overall 14.6% increase, or an annual increase of 1.5%. However, the inflation-adjusted rate was $847,058,465 in 2009, compared to $829,987,636 in 2018, a reduction overall of 2% and an annual reduction of 0.2%. Inflation-adjusted per patient annual costs decreased from $988.93 in 2009 to $819.27 in 2018 with a decrease of 17.2% or an annual decline of 2.1%. In addition, inflation-adjusted costs per procedure decreased from $399.77 to $377.94, or 5.5% overall and 0.6% annually. Per procedure, episode, visit, and patient expenses were higher for transforaminal epidural procedures than lumbar interlaminar/caudal epidural procedures. Overall, costs of transforaminal epidurals increased 27.6% or 2.7% annually, whereas lumbar interlaminar and caudal epidural injections cost were reduced 2.7%, or 0.3% annually. Inflation-adjusted costs for transforaminal epidurals increased 9.1% or 1.0% annually and declined 16.9 or 2.0% annually for lumbar interlaminar and caudal epidural injections.Expenditures for epidural procedures in chronic spinal pain were assessed only in the FFS Medicare population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans.After adjusting for inflation, there was a decrease of expenditures for epidural procedures of 2%, or 0.2% annually, from 2009 to 2018. However, prior to inflation, the increases were noted at 14.6% and 1.5%. Inflation-adjusted costs per patient, per visit, and per procedure also declined. The proportion of Medicare patients per 100,000 receiving epidural procedures decreased 9.1%, or 1.1% annually. However, assessment of individual procedures showed higher costs for transforaminal epidural procedures compared to lumbar interlaminar and caudal epidural procedures.
- Published
- 2021
31. Assessment of Prevalence of Cervical Facet Joint Pain with Diagnostic Cervical Medial Branch Blocks: Analysis Based on Chronic Pain Model
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Laxmaiah, Manchikanti, Radomir, Kosanovic, Kimberly A, Cash, Vidyasagar, Pampati, Amol, Soin, Alan D, Kaye, and Joshua A, Hirsch
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Adult ,Male ,Neck Pain ,Lidocaine ,Nerve Block ,Middle Aged ,Arthralgia ,Bupivacaine ,Zygapophyseal Joint ,Prevalence ,Humans ,Pain Management ,Female ,Anesthetics, Local ,Chronic Pain ,Retrospective Studies - Abstract
Research into cervical spinal pain syndromes has indicated that the cervical facet joints can be a potent source of neck pain, headache, and referred pain into the upper extremities. There have been multiple diagnostic accuracy studies, most commonly utilizing diagnostic facet joint nerve blocks and an acute pain model, as Bogduk has proposed. Subsequently, Manchikanti has focused on the importance of the chronic pain model and longer lasting relief with diagnostic blocks.To assess diagnostic accuracy of cervical facet joint nerve blocks with controlled comparative local anesthetic blocks, with updated assessment of prevalence, false-positive rate, and a description of philosophical paradigm shift from acute to chronic pain model, with concordant pain relief.This diagnostic accuracy study was performed with retrospective assessment of data to assess prevalence and false-positive rates.The study was performed in a non-university-based, multidisciplinary, interventional pain management, private practice in the United States.Cervical medial branch blocks were performed utilizing lidocaine 1% followed by bupivacaine 0.25% when appropriate response was obtained in an operating room under fluoroscopic guidance with 0.5 mL of lidocaine or bupivacaine from C3-C6 medial branches (levels blocked on joints involved). If a patient failed to respond to lidocaine with appropriate= 80% pain relief, that patient was considered as negative for facet joint pain. If the response was positive with lidocaine block, a bupivacaine block was performed.The chronic cervical facet joint pain was diagnosed with cervical facet joint nerve blocks at a prevalence of 49.3% (95% CI, 43.6%, 55.0%) and with a false-positive rate of 25.6% (95% CI, 19.5%, 32.8%). This study also showed a single block prevalence rate of 66.3% (95% CI, 71.7%, 60.9%). Assessment of the duration of relief with each block showed greater than 80% for 6 days with lidocaine block and total relief of= 50% of 31 days. In contrast, with bupivacaine, average duration of pain relief of= 80% was 12 days with a total relief of= 50% lasting for 55 days.Based on this investigation, utilizing a chronic pain model, there was significant difference in the relief patterns. This assessment showed prevalence and false-positive rates of 49.3% and 25.6% in chronic neck pain. Duration of relief= 80% pain relief was 6 days with lidocaine and 12 days with bupivacaine, with total relief of= 50% of 31 days with 55 days respectively.
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- 2020
32. Low Back Pain and Diagnostic Lumbar Facet Joint Nerve Blocks: Assessment of Prevalence, False-Positive Rates, and a Philosophical Paradigm Shift from an Acute to a Chronic Pain Model
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Laxmaiah, Manchikanti, Radomir, Kosanovic, Vidyasagar, Pampati, Kimberly A, Cash, Amol, Soin, Alan D, Kaye, and Joshua A, Hirsch
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Adult ,Male ,Prevalence ,Humans ,False Positive Reactions ,Female ,Nerve Block ,Chronic Pain ,Middle Aged ,Arthralgia ,Low Back Pain ,Zygapophyseal Joint ,Retrospective Studies - Abstract
Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks.To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model.Retrospective study to determine diagnostic accuracy, prevalence and false-positive rates.A multidisciplinary, non-university based interventional pain management practice in the United States.Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with= 80% pain relief for their ability to perform previously painful movements.The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief= 80% was 6 days with lidocaine block and total relief of= 50% of 32 days. With bupivacaine, the average duration of pain relief= 80% was 13 days with total relief of= 50% lasting for 55 days.This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%.
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- 2020
33. Ohio Response to COVID-19 and Its Impact on Interventional Pain Management Practices
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Gregory Surfield, Akash Rajaratnam, Ricardo M. Buenaventura, Alex Escobar, Rahul Madan, Atul Chandoke, Shalini Shah, Harsh Sachdeva, Yasmeen Soin, Mark Malinowski, Tammy L Dann, Omar Khan, Humam Akbik, Rajbir Minhas, Amol Soin, Aarti Singla, and Srinivas Vuppala
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Population ,Pneumonia, Viral ,Disease ,Telehealth ,Betacoronavirus ,Pandemic ,Health care ,Medicine ,Infection control ,Humans ,Pain Management ,education ,Pandemics ,Ohio ,education.field_of_study ,business.industry ,SARS-CoV-2 ,Social distance ,COVID-19 ,medicine.disease ,Anesthesiology and Pain Medicine ,Communicable Disease Control ,Medical emergency ,Interventional pain management ,business ,Coronavirus Infections - Abstract
Background: The coronavirus disease 2019 (COVID-19) pandemic has drastically altered daily living and medical care for Ohio residents and the practice of medicine for the interventional pain management physician. As a state, Ohio tends to be demographically representative of the broader US population. Objective: Reviewing the efforts deployed by Ohio to flatten the COVID-19 infection curve and reduce the spread of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important component of determining optimal procedures for mitigating the effects of the COVID-19 pandemic. Methods: Over the course of several announcements and orders during the months of March and April, new policies were put into place to prevent COVID-19 transmission, which included efforts to facilitate social distancing and ensure the health care system could manage the number of COVID-19 cases at peak infection rate. Efforts directed toward medical providers included delay of elective procedures, expansion of telehealth options, and new temporary guidance for prescribing controlled substances. Results: The Ohio COVID-19 containment approach resulted in a substantial reduction in COVID-19 cases compared with early models of disease spread, and the state has begun a phased reopening. Continued vigilance in applying social distancing and infection control measures will be a critical component of preventing or reducing the impact of a second wave of COVID-19 in Ohio. Limitations: A narrative review with paucity of literature. Key words: COVID-19, infection rates, mitigating effects, pandemic, infection control
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- 2020
34. Steroid Distancing in Interventional Pain Management During COVID-19 and Beyond: Safe, Effective and Practical Approach
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Laxmaiah Manchikanti, Joshua A Hirsch, Rachana Vanaparthy, Shalini Shah, Radomir Kosanovic, Amol Soin, Brahma Prasad Vangala, Nebojsa Nick Knezevic, and Harsh Sachdeva
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musculoskeletal diseases ,Lidocaine ,medicine.drug_class ,Pneumonia, Viral ,Anti-Inflammatory Agents ,Injections, Epidural ,Facet joint ,Injections, Intra-Articular ,Betacoronavirus ,Adrenal Cortex Hormones ,Radiculitis ,medicine ,Humans ,Pain Management ,Anesthetics, Local ,Pandemics ,Bupivacaine ,Local anesthetic ,business.industry ,SARS-CoV-2 ,Chronic pain ,COVID-19 ,medicine.disease ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Anesthesia ,Interventional pain management ,business ,Coronavirus Infections ,medicine.drug ,Hormone - Abstract
Background: Since the late 1940s, corticosteroids have been a mainstay class of agents in multiple interventional techniques and intra-articular injections. Exogenous glucocorticoids are structurally and pharmacologically similar to the endogenous hormones. As such, multiple actions of corticosteroids are exhibited, including those of anti-inflammatory and immunosuppressive effects. Epidural injections, with or without steroids, have been extensively used throughout the world. There are reports of epidural injections starting in 1901, with steroids being added to the local anesthetic since 1952, when steroids were administered into the sacral foramen. Purpose: Due to the extensive side effects of steroids in various injections, some have proposed limiting their use in epidurals and intraarticular injections. With the COVID-19 pandemic, the multiple side effects of the steroids have elevated the level of concern and recommendations have been made to utilize local anesthetic alone or the lowest dose of steroids. Fashioned from common expressions of the day, the term “steroid distancing” began to be used and proposed for intraarticular injections of the knee. Consequently, we sought to evaluate the evidence and feasibility of steroid distancing in interventional pain management. Methods: This focused review of local anesthetics and steroids utilized in interventional pain management for epidural injections, peripheral nerve blocks, and intraarticular injections by multiple database searches. This is a focused narrative review and not a systematic review. Consequently, evidence synthesis was not performed traditionally, but was based on an overview of the available evidence. Results: No significant difference was identified based on whether steroids are added to local anesthetic or not for epidural as well as facet joint injections. However, there was not enough evidence to compare these 2 groups for peripheral intraarticular injections. Limitations: The present review is limited by the paucity of literature with bupivacaine alone or bupivacaine with steroids local anesthetic alone or with steroids of intraarticular injections of knee, hip, shoulder and other joints, and intraarticular facet joint injections. Conclusion: This review shows an overall lack of significant difference between lidocaine alone and lidocaine with steroids in epidural injections. However, available evidence is limited for bupivacaine alone or with steroids. Evidence is also not available comparing local anesthetic alone with steroids for facet joint or peripheral joint intraarticular injections. Thus, it is concluded that local anesthetic with lidocaine may be utilized for epidural injections, with appropriate patient selection and steroids reserved for non-responsive patients with local anesthetic and with significant radiculitis. Key words: Steroid distancing, chronic pain, steroids, epidural injections, local anesthetic alone, local anesthetic with steroid, steroid distancing, physical distancing
- Published
- 2020
35. COVID-19 risk mitigation for return to practice for chronic pain physicians: risk stratification guidelines and practice management tools
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Kartic Rajput, Christopher Gharibo, Amol Soin, Sudhir Diwan, and Shalini Shah
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Risk stratification ,Chronic pain ,medicine ,General Medicine ,Practice management ,medicine.disease ,business ,Intensive care medicine ,Risk management - Published
- 2020
- Full Text
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36. Trends of Expenditures and Utilization of Facet Joint Interventions in Fee-For-Service (FFS) Medicare Population from 2009-2018
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Laxmaiah, Manchikanti, Vidyasagar, Pampati, Amol, Soin, Rachana, Vanaparthy, Mahendra R, Sanapati, Alan D, Kaye, and Joshua A, Hirsch
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Male ,Humans ,Pain Management ,Female ,Chronic Pain ,Health Expenditures ,Medicare ,Centers for Medicare and Medicaid Services, U.S ,Neurosurgical Procedures ,United States ,Zygapophyseal Joint ,Aged - Abstract
The trends of the expenditures of facet joint interventions have not been specifically assessed in the fee-for-service (FFS) Medicare population since 2009.The objective of this investigation is to assess trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009 to 2018.The study was designed to analyze trends of expenditures and utilization of facet joint interventions in FFS Medicare population from 2009-2018 in the United States. In this manuscript: • A patient was considered as undergoing facet joint interventions throughout the year. • A visit included all regions treated during the visit. • An episode was considered as one per region utilizing primary codes only. • Services or procedures were considered all procedures (multiple levels). Data for the analysis was obtained from the standard 5% national sample of the Centers for MedicareMedicaid Services (CMS) physician outpatient billing claims for those enrolled in the FFS Medicare program from 2009 to 2018. All the expenditures were presented with allowed costs and also were inflation adjusted to 2018 US dollars.This analysis showed expenditures increased by 79% from 2009 to 2018 in the form of total cost for facet joint interventions, at an annual rate of 6.7%. Cervical and lumbar radiofrequency neurotomy procedures increased 185% and 169%. However, inflation-adjusted expenditures with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. In addition, using inflation-adjusted expenditures per procedures increased, the overall 6% with an annual increase of 0.7%. Overall, per patient costs, with inflation adjustment, decreased from $1,925 to $1,785 with a decline of 7% and an annual decline of 0.8%. Allowed charges per visit also declined after inflation adjustment from $951.76 to $849.86 with an overall decline of 11% and an annual decline of 1.3%. Staged episodes of radiofrequency neurotomy were performed in 23.9% of patients and more than 2 episodes for radiofrequency neurotomy in 6.9%, in lumbar spine and 19.6% staged and 5.1% more than 2 episodes in cervical spine of patients in 2018.This analysis is limited by inclusion of only the FFS Medicare population, without adding utilization patterns of Medicare Advantage plans, which constitutes almost 30% of the Medicare population.Even after adjusting for inflation, there was a significant increase for the expenditures of facet joint interventions with an overall 53% increase. Costs per patient and cost per visit declined. Inflation-adjusted cost per year declined 7% overall and 0.8% annually from $1,925 to $1,785, and inflation-adjusted cost per visit also declined 11% annually and 1.3% per year from $952 in 2009 to $850 in 2018.Facet joint interventions, facet joint nerve blocks, facet joint neurolysis, facet joint injections, Medicare expenditures.
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- 2020
37. 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
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Laxmaiah, Manchikanti, Alan D, Kaye, Amol, Soin, Sheri L, Albers, Douglas, Beall, Richard, Latchaw, Mahendra R, Sanapati, Shalini, Shah, Sairam, Atluri, Alaa, Abd-Elsayed, Salahadin, Abdi, Steve, Aydin, Sanjay, Bakshi, Mark V, Boswell, Ricardo, Buenaventura, Joseph, Cabaret, Aaron K, Calodney, Kenneth D, Candido, Paul J, Christo, Lynn, Cintron, Sudhir, Diwan, Christopher, Gharibo, Jay, Grider, Mayank, Gupta, Bill, Haney, Michael E, Harned, Standiford, Helm Ii, Jessica, Jameson, Sunny, Jha, Adam M, Kaye, Nebojsa Nick, Knezevic, Radomir, Kosanovic, Maanasa V, Manchikanti, Annu, Navani, Gabor, Racz, Vidyasagar, Pampati, Ramarao, Pasupuleti, Cyril, Philip, Kartic, Rajput, Nalini, Sehgal, Gururau, Sudarshan, Rachana, Vanaparthy, Bradley W, Wargo, and Joshua A, Hirsch
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Back Pain ,Humans ,Pain Management ,Chronic Pain ,United States ,Zygapophyseal Joint - Abstract
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.To provide evidence-based guidance in performing diagnostic and therapeutic facet joint interventions.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.The limitations of these guidelines include a paucity of high-quality studies in the majority of aspects of diagnosis and therapy.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.Chronic spinal pain, interventional techniques, diagnostic blocks, therapeutic interventions, facet joint nerve blocks, intraarticular injections, radiofrequency neurolysis.
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- 2020
38. An Updated Analysis of Utilization of Epidural Procedures in Managing Chronic Pain in the Medicare Population from 2000 to 2018
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Laxmaiah, Manchikanti, Mahendra R, Sanapati, Amol, Soin, Maanasa V, Manchikanti, Vidyasagar, Pampati, Vanila, Singh, and Joshua A, Hirsch
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Aged, 80 and over ,Anesthesia, Epidural ,Male ,Lumbosacral Region ,Humans ,Injections, Epidural ,Pain Management ,Female ,Chronic Pain ,Medicare ,Anesthesia, Spinal ,United States ,Aged - Abstract
With increasing costs of health care in the United States, attention is focused on expensive conditions. Musculoskeletal disorders with low back and neck pain account for the third highest amount of various disease categories. Minimally invasive interventional techniques for managing spinal pain, including epidural injections, have been considered to be growing rapidly. However, recent analyses of utilization of interventional techniques from 2000 to 2018 has shown a decline of 2.6% and a decline of 21% from 2009 to 2018 for epidural and adhesiolysis procedures.The objectives of this analysis of epidural procedures from 2000 to 2018 are to provide an update on utilization of epidural injections in managing chronic pain in the fee-for-service (FFS) Medicare population, with a comparative analysis of 2000 to 2009 and 2009 to 2018.Utilization patterns and variables of epidural injections in managing chronic spinal pain from 2000 to 2009 and from 2009 to 2018 in the FFS Medicare population in the United States.This analysis was performed by utilizing master data from CMS, physician/supplier procedure summary from 2000 to 2018. The analysis was performed by the assessment of utilization patterns using guidance from Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).Overall, epidural procedures declined at a rate of 20.7% per 100,000 Medicare enrollees in FFS Medicare in the United States from 2009 to 2018, with an annual decline of 2.5%. However, from 2000 to 2009, there was an increase of 89.2%, with an annual increase of 7.3%. This analysis showed a decline in all categories, with an annual decrease of 4.7% for lumbar interlaminar and caudal epidural injections, 4.7% decline for cervical/thoracic transforaminal epidural injections, 1.1% decline for lumbar/sacral transforaminal epidural injections, and finally 0.4% decline for cervical/thoracic interlaminar epidural injections. Overall declines from 2009 to 2018 were highest for cervical and thoracic transforaminal injections with 35.1%, followed by lumbar interlaminar and caudal epidural injections of 34.9%, followed by 9.4% for lumbar/sacral transforaminal epidurals, and 3.5% for cervical and thoracic interlaminar epidurals.This analysis was limited by noninclusion of Medicare Advantage plans, which constitutes almost 30% of the Medicare population. In addition, utilization data for individual states continues to be sparse and may not be accurate or representative of the population.The declining utilization of epidural injections in all categories with an annual of 2.5% and overall decrease of 20.7% from 2009 to 2018 compared with annual increases of 7.3% and overall increase of 89.2% from 2000 to 2009 shows a slow decline of utilization of all epidural injections.Chronic spinal pain, interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, utilization patterns.
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- 2020
39. Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)
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Laxmaiah, Manchikanti, Christopher J, Centeno, Sairam, Atluri, Sheri L, Albers, Shane, Shapiro, Gerard A, Malanga, Alaa, Abd-Elsayed, Mairin, Jerome, Joshua A, Hirsch, Alan D, Kaye, Steve M, Aydin, Douglas, Beall, Don, Buford, Joanne, Borg-Stein, Ricardo M, Buenaventura, Joseph A, Cabaret, Aaron K, Calodney, Kenneth D, Candido, Cameron, Cartier, Richard, Latchaw, Sudhir, Diwan, Ehren, Dodson, Zachary, Fausel, Michael, Fredericson, Christopher G, Gharibo, Mayank, Gupta, Adam M, Kaye, Nebojsa Nick, Knezevic, Radomir, Kosanovic, Matthew, Lucas, Maanasa V, Manchikanti, R Amadeus, Mason, Kenneth, Mautner, Samuel, Murala, Annu, Navani, Vidyasagar, Pampati, Sarah, Pastoriza, Ramarao, Pasupuleti, Cyril, Philip, Mahendra R, Sanapati, Theodore, Sand, Rinoo V, Shah, Amol, Soin, Ian, Stemper, Bradley W, Wargo, and Philippe, Hernigou
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Evidence-Based Medicine ,Treatment Outcome ,Bone Marrow ,United States Food and Drug Administration ,Physicians ,Humans ,Pain ,Pain Management ,Musculoskeletal Diseases ,Societies, Medical ,United States ,Bone Marrow Transplantation ,Randomized Controlled Trials as Topic - Abstract
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.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.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.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.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.
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- 2020
40. A Randomized, Double-Blind Study of the Effects of a Sustained Release Formulation of Sodium Nitrite (SR-nitrite) on Patients with Diabetic Neuropathy
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Chirag Patel, Anthony Giordano, Amol Soin, Glen Bock, and David Drachman
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Adult ,Male ,0301 basic medicine ,Schmidt sting pain index ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Diabetic Neuropathies ,Double-Blind Method ,Randomized controlled trial ,law ,medicine ,Humans ,Brief Pain Inventory ,Aged ,Pain Measurement ,Sodium Nitrite ,business.industry ,Chronic pain ,Middle Aged ,medicine.disease ,Treatment Outcome ,030104 developmental biology ,Anesthesiology and Pain Medicine ,Peripheral neuropathy ,Delayed-Action Preparations ,Anesthesia ,Neuropathic pain ,Neuralgia ,Female ,Chronic Pain ,Headaches ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Background: Background: Sodium nitrite has been reported to be effective in reducing chronic peripheral pain. Objectives: To evaluate the safety and efficacy of 40 and 80 mg, BID, of an oral sustained release formulation of sodium nitrite (SR-nitrite) in patients suffering from diabetic neuropathy, and to determine whether SR-nitrite would reduce the frequency of headaches reported previously by subjects receiving the same doses of an immediate release formulation. Study Design: Phase II, single-center, randomized, double-blind, placebo controlled clinical trial. Setting: The Ohio Pain Clinic and Kettering Medical Center. Methods: Twenty-four patients were randomized to 40 mg or 80 mg SR-nitrite or placebo twice daily for 12 weeks. The primary objective was to determine whether headaches would be reduced using SR-nitrite. The primary efficacy endpoint was the mean difference in the change of the Neuropathic Pain Symptom Inventory (NPSI) pain score from baseline to that reported after 12 weeks of treatment. Secondary endpoints included changes from baseline for the Brief Pain Inventory (BPI) Scale, the RAND 36 questionnaire, Short Form McGill Questionnaire, daily patient reported score for neuropathic pain, changes in HbA1c, PulseOx and quantitative sensory testing. Results: The number of subjects reporting adverse events and the number of adverse events did not change with dose. There were no reports of treatment-related headaches. Although no significant differences were identified in patient responses to the questionnaires, a trend was observed. In the NPSI assessment, patients in the 40 mg and 80 mg dose group reported a 12.7% and 22.0% reduction in pain, respectively, compared to an 8.4% reduction by patients in the placebo group. A trend was also observed with the BPI total severity score. However, the 40 mg dosing group reported the greatest reduction in pain using the McGill Pain index and via patient logs of daily pain scores, where the mean of pain scores reported by subjects in the 40 mg group dropped by day 41 and generally stayed lower than the mean of scores reported by subjects in either of the other two groups. Patients in the 80 mg SR-nitrite group had an improvement in both Nerve Sensory Conductance and Nerve Sensory Velocity. No changes were observed in HbA1c levels or PulseOx. Limitations: Small sample size. Conclusion: Sustained release sodium nitrite prevents the prevalent reports of headaches by patients treated with an immediate release formulation of sodium nitrite. In a previous study of patients with peripheral arterial disease (PAD), 40 mg BID treatment led to a statistically significant reduction in reported pain, similar trends were observed at the end of the trial period for most of the pain questionnaires used in the study. The 80 mg BID treatment had the more pronounced affect on bioactivity (quantitative sensory testing), which was similar to the PAD study, where this dose group had the greatest improvement in FMD {AU: spell out FMD}. The ability to alleviate pain with BID treatment of SR-nitrite offers promise for a new non-addictive, non-sedating treatment of chronic pain and warrants further study. Key words: diabetes, diabetic neuropathy, neuropathic pain, peripheral neuropathy, sodium nitrite
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- 2018
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41. An Update of the Systematic Appraisal of the Accuracy and Utility of Discography in Chronic Spinal Pain
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Frank J E Falco, Joshua A Hirsch, Aaron K. Calodney, Singh, Grami, Ramsin M Benyamin, Laxmaiah Manchikanti, and Amol Soin
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medicine.medical_specialty ,business.industry ,Provocation test ,MEDLINE ,Discography ,Intervertebral disc ,Evidence-based medicine ,Intervertebral disc disorders ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Lumbar ,030202 anesthesiology ,medicine ,Back pain ,Physical therapy ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Background: The intervertebral disc has been implicated as a major cause of chronic spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients, and in 16% to 53% of patients with pain in the cervical spine. Lumbar, cervical, and thoracic provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature on point, intense debate continues about lumbar discography as a diagnostic tool. Study Design: A systematic review of the diagnostic accuracy of lumbar, cervical, and thoracic provocation and analgesic discography literature. Objective: To systematically assess and re-evaluate the diagnostic accuracy of lumbar, cervical, and thoracic discography. Methods: The available literature on discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. To assess the level of evidence, a modified grading of qualitative evidence criteria was utilized, with grading of evidence into 5 categories from Level I to Level V incorporating evidence obtained from multiple high quality diagnostic accuracy studies for Level I and opinion or consensus of a large group of clinicians and/or scientists for Level V. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2017, and manual searches of the bibliographies of known primary and review articles. Results: Over 100 manuscripts were considered for inclusion. Of these, 8 studies met inclusion criteria for diagnostic accuracy and prevalence with 5 studies assessing lumbar provocation discography and 3 studies assessing cervical discography. The results showed variable prevalence from 16.9% to 26% for discogenic pain and 16.9% to 42% for internal disc disruption. The cervical discogenic pain prevalence ranged from 16% to 53%. Based on methodological quality assessment criteria the strength of evidence for lumbar provocation discography is Level III and for cervical discogenic pain is Level IV. Limitations: Despite multiple publications in the lumbar spine, value and validity of discography continues to be debated. In reference to cervical and thoracic discography, the available literature and value and validity continues to be low. Conclusion: This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. The evidence is weaker for cervical and nonexistent for thoracic discography. Key words: Lumbar intervertebral disc, cervical intervertebral disc, thoracic intervertebral disc, discography, provocation discography, analgesic discography, diagnostic accuracy, prevalence
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- 2018
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42. Reversal of Growth of Utilization of Interventional Techniques in Managing Chronic Pain in Medicare Population Post Affordable Care Act
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Sanjay Bakshi, Laxmaiah Manchikanti, Amol Soin, Dharam P Mann, Joshua A Hirsch, and Vidyasagar Pampati
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Male ,medicine.medical_specialty ,Psychological intervention ,Medicare Advantage ,Medicare ,Zygapophyseal Joint ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,030202 anesthesiology ,medicine ,Humans ,Pain Management ,Injections, Spinal ,Aged ,Retrospective Studies ,Aged, 80 and over ,Sacroiliac joint ,business.industry ,Patient Protection and Affordable Care Act ,Chronic pain ,Nerve Block ,Sacroiliac Joint ,Retrospective cohort study ,medicine.disease ,United States ,Analgesia, Epidural ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Back Pain ,Emergency medicine ,Female ,Chronic Pain ,Interventional pain management ,business ,Medicaid ,030217 neurology & neurosurgery ,Cohort study - Abstract
Background: Over the past 2 decades, the increase in the utilization of interventional techniques has been a cause for concern. Despite multiple regulations to reduce utilization of interventional techniques, growth patterns continued through 2009. A declining trend was observed in a previous evaluation; however, a comparative analysis of utilization patterns of interventional techniques has not been performed showing utilization before and after the enactment of the Affordable Care Act (ACA). Objectives: Our aim is to assess patterns of utilization and variables of interventional techniques in chronic pain management in the fee-for-service (FFS) Medicare population, with a comparative analysis of pre- and post-ACA. Study Design: Utilization patterns and variables of interventional techniques were assessed from 2000 to 2009 and from 2009 to 2016 in the FFS Medicare population of the United States in managing chronic pain. Methods: The master data from the Centers for Medicare & Medicaid Services (CMS) physician/ supplier procedure summary from 2000 to 2016 was utilized to assess overall utilization and comparative utilization at various time periods. Results: The analysis of Medicare data from 2000 to 2016 showed an overall decrease in utilization of interventional techniques 0.6% per year from 2009 to 2016, whereas from 2000 to 2009, there was an increase of 11.8% per year per 100,000 individuals of the Medicare population. In addition, the United States experienced an increase of 0.7% per year of population growth, 3.2% of those 65 years or older and a 3% annual increase in Medicare participation from 2009 to 2016. Further analysis also showed a 1.7% annual decrease in the rate of utilization of epidural and adhesiolysis procedures per 100,000 individuals of the Medicare population, with a 2.2% decrease for disc procedures and other types of nerve blocks, whereas there was an increase of 0.8% annually for facet joint interventions and sacroiliac joint blocks from 2009 to 2016. Epidural and adhesiolysis procedures showed an 8.9% annual increase, facet joint interventions and sacroiliac joint blocks showed a 17.6% increase, and disc procedures and other types of nerve blocks showed a 7.2% increase annually per 100,000 individuals of the Medicare population from 2000 to 2009. Limitations: The limitations of this assessment include lack of analysis of individual procedures. Additional limitations include lack of inclusion of patients from Medicare Advantage plans and lack of complete and accurate data for statewide utilization. Conclusion: From 2009 to 2016, interventional techniques decreased at an annual rate of 0.6% with an overall decrease of 3.9%, compared to an overall increase of 173.6% from 2000 to 2009 with an annual increase of 11.8%. An additional analysis of data with individual procedures is essential to gain further insights into utilization patterns. Key words: Interventional pain management, chronic spinal pain, interventional techniques, epidural injections, adhesiolysis, facet joint interventions, sacroiliac joint injections, disc procedures, other types of nerve blocks
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- 2017
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43. TIME-COURSE AND EFFECTS OF PULSED RADIOFREQUENCY ON ACUTE PAIN AND THE SENSE OF TOUCH IN ABLE-BODIED SUBJECTS
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Erin Dewenter, Dan Guerrero, Shyamy Sastry, Phillip Schorr, Jalpa Shah, David Page, Eric Schepis, Amol Soin, and Natalia Alexeeva
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- 2019
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44. PERCUTANEOUS ELECTRICAL NERVE BLOCK OF ACUTE PAIN IN HUMANS
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Shyamy Sastry, Phillip Schorr, Erin Dewenter, Ryan Caldwell, Eric Schepis, Brandon Winchester MD, Amol Soin, and Natalia Alexeeva
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- 2019
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45. Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain: a Retrospective Cohort Study in the US Fee-for-Service Medicare Population
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Alan D. Kaye, Vidyasagar Pampati, Amol Soin, Dharam P Mann, Laxmaiah Manchikanti, Joshua A Hirsch, and Sanjay Bakshi
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musculoskeletal diseases ,Facet (geometry) ,medicine.medical_specialty ,Psychological intervention ,Medicare ,Neurosurgical Procedures ,Zygapophyseal Joint ,Facet joint ,03 medical and health sciences ,0302 clinical medicine ,030202 anesthesiology ,medicine ,Humans ,Pain Management ,Fee-for-service ,Neurolysis ,business.industry ,Retrospective cohort study ,General Medicine ,musculoskeletal system ,United States ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Back Pain ,Medicare population ,Physical therapy ,Neurology (clinical) ,Chronic Pain ,business ,030217 neurology & neurosurgery ,Lumbosacral joint - Abstract
To assess patterns of utilization and variables of facet joint interventions in managing chronic spinal pain in a fee-for-service (FFS) Medicare population from 2009 to 2016, with a comparative analysis from 2000 to 2009 and 2009 to 2016. From 2009 to 2016, facet joint interventions increased at an annual rate of 2% per 100,000 Medicare population compared to 10.2% annual rate of increase from 2000 to 2009. Lumbosacral facet joint nerve block episodes decreased at an annual rate of 0.1% from 2009 to 2016, with an increase of 16.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis episodes increased at an annual rate of 7.6% from 2009 to 2016 and the utilization rate also increased at an annual rate of 26% from 2000 to 2009. The ratio of lumbar facet joint block episodes to lumbosacral facet joint neurolysis episodes changed from 6.7 in 2000 to 2.2 in 2016. From 2009 to 2016, cervical and thoracic facet joint injections increased at an annual rate of 0.6% compared to cervicothoracic facet neurolysis episodes of 9.2%. During 2000 to 2009, annual increase of cervical facet joint injections was 18% compared to neurolysis procedures of 26%. The ratio of cervical facet joint injections episodes to neurolysis episodes changed from 8.85 in 2000 to 2.8 in 2016. In summary, based on available data, utilization patterns of facet joint interventions demonstrated an increase of 2% per 100,000 Medicare population from 2009 to 2016, with an annual decline of lumbar facet joint injection episodes.
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- 2019
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46. Effectiveness of Percutaneous Adhesiolysis in Post Lumbar Surgery Syndrome: A Systematic Analysis of Findings of Systematic Reviews
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Laxmaiah, Manchikanti, Amol, Soin, Mark V, Boswell, Alan D, Kaye, Mahendra, Sanapati, and Joshua A, Hirsch
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Treatment Outcome ,Lumbosacral Region ,Humans ,Pain Management ,Reproducibility of Results ,Tissue Adhesions ,Chronic Pain ,Failed Back Surgery Syndrome ,Low Back Pain ,Systematic Reviews as Topic - Abstract
Post lumbar surgery syndrome is common and often results in chronic, persistent pain and disability, which can lead to multiple interventions. After failure of conservative treatment, either surgical treatment or a nonsurgical modality of treatment such as epidural injections, percutaneous adhesiolysis are often contemplated in managing post lumbar surgery syndrome. Multiple previous systematic reviews have reached discordant conclusions about the level of evidence for the effectiveness of percutaneous adhesiolysis in managing post lumbar surgery syndrome and other conditions.A systematic review of previously published systematic reviews assessing efficacy of percutaneous adhesiolysis in managing post lumbar surgery syndrome.To evaluate the value and validity of previous systematic reviews performed after 2015 on effectiveness of percutaneous adhesiolysis in managing chronic refractory low back and lower extremity pain secondary to post lumbar surgery syndrome.Previous systematic reviews on percutaneous adhesiolysis were evaluated. The quality of each systematic review was assessed by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews (AMSTAR).The randomized trials included in the available systematic reviews were assessed by Cochrane review criteria and Interventional Pain Management techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for methodologic quality.Data sources included relevant systematic reviews and the randomized trials included in those systematic reviews published since 2015 with searches of PubMed, Cochrane reviews, and Google Scholar through February 2019.Outcome measures were significant improvement defined as 50% pain relief and improvement in functional status. Short-term efficacy was defined as improvement of 6 months or less, whereas long-term efficacy was defined as more than 6 months.Three systematic reviews and 4 randomized controlled trials (RCTs) of post lumbar surgery syndrome with chronic refractory low back and lower extremity pain showed notable evidence of significant pain relief. Only one systematic review, which was of low quality with inappropriate analysis, showed lack of evidence.Overall, the present analysis shows Level I evidence for percutaneous adhesiolysis based on significant evidence from published RCTs and 3 of the 4 systematic reviews.Post lumbar surgery syndrome, epidural fibrosis, percutaneous adhesiolysis, systematic reviews, randomized controlled trials.
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- 2019
47. Responsible, Safe, and Effective Use of Antithrombotics and Anticoagulants in Patients Undergoing Interventional Techniques: American Society of Interventional Pain Physicians (ASIPP) Guidelines
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Laxmaiah Manchikanti, Richard D. Urman, Michael E. Harned, Thomas T. Simopoulos, Joshua A Hirsch, Kenneth D. Candido, Mahendra R Sanapati, Matthew B. Novitch, Elyse M. Cornett, Erik M. Helander, Sudhir Diwan, Ramsin M Benyamin, Bakhit Ce, John R. Swicegood, Alan D. Kaye, Ramarao Pasupuleti, Mark R. Jones, Sheri L. Albers, Richard E. Latchaw, Hari Prabhakar, Sairam Atluri, Douglas P. Beall, Nebojsa Nick Knezevic, Amol Soin, Imran N. Mungrue, Timothy R. Deer, Ricardo Vallejo, Muhammad Anwar, Jay S. Grider, Matthew R. Eng, and Salahadin Abdi
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medicine.medical_specialty ,Hemorrhage ,Argatroban ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Fibrinolytic Agents ,030202 anesthesiology ,Edoxaban ,Antithrombotic ,medicine ,Humans ,Pain Management ,Intensive care medicine ,Rivaroxaban ,business.industry ,Warfarin ,Anticoagulants ,Discontinuation ,Anesthesiology and Pain Medicine ,chemistry ,Apixaban ,Interventional pain management ,Chronic Pain ,business ,medicine.drug - Abstract
Background: Interventional pain management involves diagnosis and treatment of chronic pain. This specialty utilizes minimally invasive procedures to target therapeutics to the central nervous system and the spinal column. A subset of patients encountered in interventional pain are medicated using anticoagulant or antithrombotic drugs to mitigate thrombosis risk. Since these drugs target the clotting system, bleeding risk is a consideration accompanying interventional procedures. Importantly, discontinuation of anticoagulant or antithrombotic drugs exposes underlying thrombosis risk, which can lead to significant morbidity and mortality especially in those with coronary artery or cerebrovascular disease. This review summarizes the literature and provides guidelines based on best evidence for patients receiving anti-clotting therapy during interventional pain procedures. Study Design: Best evidence synthesis. Objective: To provide a current and concise appraisal of the literature regarding an assessment of the bleeding risk during interventional techniques for patients taking anticoagulant and/or antithrombotic medications. Methods: A review of the available literature published on bleeding risk during interventional pain procedures, practice patterns and perioperative management of anticoagulant and antithrombotic therapy was conducted. Data sources included relevant literature identified through searches of EMBASE and PubMed from 1966 through August 2018 and manual searches of the bibliographies of known primary and review articles. Results: 1. There is good evidence for risk stratification by categorizing multiple interventional techniques into low-risk, moderate-risk, and high-risk. Also, their risk should be upgraded based on other risk factors. 2. There is good evidence for the risk of thromboembolic events in patients who interrupt antithrombotic therapy. 3. There is good evidence supporting discontinuation of low dose aspirin for high risk and moderate risk procedures for at least 3 days, and there is moderate evidence that these may be continued for low risk or some intermediate risk procedures.4. There is good evidence that discontinuation of anticoagulant therapy with warfarin, heparin, dabigatran (Pradaxa®), argatroban (Acova®), bivalirudin (Angiomax®), lepirudin (Refludan®), desirudin (Iprivask®), hirudin, apixaban (Eliquis®), rivaroxaban (Xarelto®), edoxaban (Savaysa®, Lixiana®), Betrixaban(Bevyxxa®), fondaparinux (Arixtra®) prior to interventional techniques with individual consideration of pharmacokinetics and pharmacodynamics of the drugs and individual risk factors increases safety. 5. There is good evidence that diagnosis of epidural hematoma is based on severe pain at the site of the injection, rapid neurological deterioration, and MRI with surgical decompression with progressive neurological dysfunction to avoid neurological sequelae. 6. There is good evidence that if thromboembolic risk is high, low molecular weight heparin bridge therapy can be instituted during cessation of the anticoagulant, and the low molecular weight heparin can be discontinued 24 hours before the pain procedure. 7. There is fair evidence that the risk of thromboembolic events is higher than that of epidural hematoma formation with the interruption of antiplatelet therapy preceding interventional techniques, though both risks are significant. 8. There is fair evidence that multiple variables including anatomic pathology with spinal stenosis and ankylosing spondylitis; high risk procedures and moderate risk procedures combined with anatomic risk factors; bleeding observed during the procedure, and multiple attempts during the procedures increase the risk for bleeding complications and epidural hematoma. 9. There is fair evidence that discontinuation of phosphodiesterase inhibitors is optional (dipyridamole [Persantine], cilostazol [Pletal]. However, there is also fair evidence to discontinue Aggrenox [dipyridamole plus aspirin]) 3 days prior to undergoing interventional techniques of moderate and high risk. 10. There is fair evidence to make shared decision making between the patient and the treating physicians with the treating physician and to consider all the appropriate risks associated with continuation or discontinuation of antithrombotic or anticoagulant therapy. 11. There is fair evidence that if thromboembolic risk is high antithrombotic therapy may be resumed 12 hours after the interventional procedure is performed. 12. There is limited evidence that discontinuation of antiplatelet therapy (clopidogrel [Plavix®], ticlopidine [Ticlid®], Ticagrelor [Brilinta®] and prasugrel [Effient®]) avoids complications of significant bleeding and epidural hematomas. 13. There is very limited evidence supporting the continuation or discontinuation of most NSAIDs, excluding aspirin, for 1 to 2 days and some 4 to 10 days, since these are utilized for pain management without cardiac or cerebral protective effect. Limitations: The continued paucity of the literature with discordant recommendations. Conclusion: Based on the survey of current literature, and published clinical guidelines, recommendations for patients presenting with ongoing antithrombotic therapy prior to interventional techniques are variable, and are based on comprehensive analysis of each patient and the risk-benefit analysis of intervention. Key words: Perioperative bleeding, bleeding risk, practice patterns, anticoagulant therapy, antithrombotic therapy, interventional techniques, safety precautions, pain
- Published
- 2019
48. Comparative Analysis of Utilization of Epidural Procedures in Managing Chronic Pain in the Medicare Population: Pre and Post Affordable Care Act
- Author
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Sanjay Bakshi, Joshua A Hirsch, Amol Soin, Laxmaiah Manchikanti, Vidyasagar Pampati, and Dharam P Mann
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medicine.medical_specialty ,MEDLINE ,Injections, Epidural ,Medicare ,03 medical and health sciences ,0302 clinical medicine ,Patient Protection and Affordable Care Act ,medicine ,Health insurance ,Humans ,Pain Management ,Orthopedics and Sports Medicine ,Pre and post ,Retrospective Studies ,030222 orthopedics ,business.industry ,Chronic pain ,Retrospective cohort study ,medicine.disease ,Spinal pain ,United States ,Back Pain ,Emergency medicine ,Medicare population ,Neurology (clinical) ,Chronic Pain ,business ,030217 neurology & neurosurgery - Abstract
A retrospective cohort study of utilization patterns of epidural injections.The aim of this study was to assess patterns of utilization and variables of in chronic spinal pain in the fee-for-service (FFS) Medicare population, with a comparative analysis of pre- and post-Affordable Care Act (ACA) data from 2000 to 2009 and 2009 to 2016.Over the years, utilization of interventional pain management techniques, specifically epidural injections have increased creating concern over costs and public health policy.The master data from the Centers for MedicareMedicaid Services (CMS) physician/supplier procedure summary from 2000 to 2016 was utilized to assess utilization patterns. The descriptive analysis of the database analysis was performed using guidance from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Multiple variables were analyzed based on the procedures, specialties, and geography.Caudal and lumbar interlaminar epidural injections decreased 25% from 2009 to 2016 with an annual decrease of 4% in contrast to lumbosacral transforaminal epidural injection episodes, increasing at an annual rate of 0.3%. In contrast, lumbar interlaminar epidural injections increased 2.4% annually, while transforaminal episodes increased 23% from 2000 to 2009. The ratio of interlaminar epidural injections to transforaminal epidural injection episodes has changed from 7 in 2000 to 1 in 2016, whereas ratio of services changed from 5 to 0.7. From 2009 to 2016, cervical/thoracic interlaminar epidural injections episodes increased at an annual rate of 0.5%, with a decrease of 2.3% for transforaminal epidural injections.Comparative analysis of the utilization of epidural injections from 2000 to 2009 and 2009 to 2016 showed vast differences with overall significant decreases in utilization, specifically for lumbar interlaminar and caudal epidural injections, with a continued, though greatly slowed increase of lumbosacral transforaminal epidural injections.3.
- Published
- 2018
49. An Update of the Systematic Appraisal of the Accuracy and Utility of Discography in Chronic Spinal Pain
- Author
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Laxmaiah, Manchikanti, Amol, Soin, Ramsin M, Benyamin, Vijay, Singh, Frank Je, Falco, Aaron K, Calodney, Vahid, Grami, and Joshua A, Hirsch
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Adult ,Back Pain ,Humans ,Reproducibility of Results ,Chronic Pain ,Intervertebral Disc - Abstract
The intervertebral disc has been implicated as a major cause of chronic spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients, and in 16% to 53% of patients with pain in the cervical spine. Lumbar, cervical, and thoracic provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature on point, intense debate continues about lumbar discography as a diagnostic tool.A systematic review of the diagnostic accuracy of lumbar, cervical, and thoracic provocation and analgesic discography literature.To systematically assess and re-evaluate the diagnostic accuracy of lumbar, cervical, and thoracic discography.The available literature on discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. To assess the level of evidence, a modified grading of qualitative evidence criteria was utilized, with grading of evidence into 5 categories from Level I to Level V incorporating evidence obtained from multiple high quality diagnostic accuracy studies for Level I and opinion or consensus of a large group of clinicians and/or scientists for Level V. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2017, and manual searches of the bibliographies of known primary and review articles.Over 100 manuscripts were considered for inclusion. Of these, 8 studies met inclusion criteria for diagnostic accuracy and prevalence with 5 studies assessing lumbar provocation discography and 3 studies assessing cervical discography. The results showed variable prevalence from 16.9% to 26% for discogenic pain and 16.9% to 42% for internal disc disruption. The cervical discogenic pain prevalence ranged from 16% to 53%. Based on methodological quality assessment criteria the strength of evidence for lumbar provocation discography is Level III and for cervical discogenic pain is Level IV.Despite multiple publications in the lumbar spine, value and validity of discography continues to be debated. In reference to cervical and thoracic discography, the available literature and value and validity continues to be low.This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. The evidence is weaker for cervical and nonexistent for thoracic discography.Lumbar intervertebral disc, cervical intervertebral disc, thoracic intervertebral disc, discography, provocation discography, analgesic discography, diagnostic accuracy, prevalence.
- Published
- 2018
50. A Systematic Review and Best Evidence Synthesis of Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain
- Author
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Jay S. Grider, Manohar Sharma, Joshua A Hirsch, Dharam P Mann, Vijay P. Singh, Christopher Gharibo, Alan D. Kaye, Ricardo Vallejo, Laxmaiah Manchikanti, Sanjay Bakshi, Bradley W. Wargo, Amol Soin, Mark V. Boswell, Sanjeeva Gupta, Sachin Sunny Jha, Vahid Grami, Lindsay N Shroyer, and Devi E. Nampiaparampil
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,business.industry ,Evidence-based medicine ,musculoskeletal system ,law.invention ,Facet joint ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Systematic review ,Physical medicine and rehabilitation ,Lumbar ,Randomized controlled trial ,law ,Meta-analysis ,medicine ,Physical therapy ,Interventional pain management ,business ,Lumbosacral joint - Abstract
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. Key Words: Spinal pain, chronic low back pain, chronic neck pain, chronic thoracic pain, intraarticular facet joint blocks, facet joint nerve blocks, conventional radiofrequency neurotomy, pulsed radiofrequency neurolysis
- Published
- 2015
- Full Text
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