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Prevalence of chronic pain after traumatic brain injury: a systematic review
Nampiaparampil, Devi E
CONTEXT: The Centers for Disease Control and Prevention estimates that approximately 1.4 million US individuals sustain traumatic brain injuries (TBIs) per year. Previous reports suggest an association between TBI and chronic pain syndromes (eg, headache) thought to be more common in patients with mild TBI and in those who have sustained brain injury from violent rather than unintentional trauma. Comorbid psychiatric disorders such as posttraumatic stress disorder (PTSD) may also mediate chronic pain symptoms. OBJECTIVES: To determine the prevalence of chronic pain as an underdiagnosed consequence of TBI and to review the interaction between chronic pain and severity of TBI as well as the characteristics of pain after TBI among civilians and combatants. EVIDENCE ACQUISITION: The Ovid/MEDLINE database was searched for articles published between 1951 and February 2008 using any combination of the terms brain injury, pain, headache, blast injury, and combat (combat disorders, war, military medicine, wounds and injuries, military personnel, veterans). The PubMed and MD Consult databases were searched in a similar fashion. The Cochrane Collaboration, National Institutes of Health Clinical Trials Database, Meta-Register of Current Controlled Trials, and CRISP databases were searched using the keyword brain injury. All articles in peer-reviewed journals reporting original data on pain syndromes in adult patients with TBI with regard to pain prevalence, pain category, risk factors, pathogenesis, and clinical course were selected, and manual searches were performed of their reference lists. The data were pooled and prevalence rates calculated. EVIDENCE SYNTHESIS: Twenty-three studies (15 cross-sectional, 5 prospective, and 3 retrospective) including 4206 patients were identified. Twelve studies assessed headache pain in 1670 patients. Of these, 966 complained of chronic headache, yielding a prevalence of 57.8% (95% confidence interval [CI], 55.5%-60.2%). Among civilians, the prevalence of chronic pain was greater in patients with mild TBI (75.3% [95% CI, 72.7%-77.9%]) compared with moderate or severe TBI (32.1% [95% CI, 29.3%-34.9%]). Twenty studies including 3289 civilian patients with TBI yielded a chronic pain prevalence of 51.5% (95% CI, 49.8%-53.2%). Three studies assessed TBI among 917 veterans and yielded a pain prevalence of 43.1% (95% CI, 39.9%-46.3%). PTSD may mediate chronic pain, but brain injury appears to have an independent correlation with chronic pain. CONCLUSIONS: Chronic pain is a common complication of TBI. It is independent of psychologic disorders such as PTSD and depression and is common even among patients with apparently minor injuries to the brain
PMID: 18698069
ISSN: 0098-7484
CID: 106482
The provocative lumbar facet joint
Binder, David S; Nampiaparampil, Devi E
Low back pain is the most common pain symptom experienced by American adults and is the second most common reason for primary care physician visits. There are many structures in the lumbar spine that can serve as pain generators and often the etiology of low back pain is multifactorial. However, the facet joint has been increasingly recognized as an important cause of low back pain. Facet joint pain can be diagnosed with local anesthetic blocks of the medial branches or of the facet joints themselves. Subsequent radiofrequency lesioning of the medial branches can provide more long-term pain relief. Despite some of the pitfalls associated with facet joint blocks, they have been shown to be valid, safe, and reliable as a diagnostic tool. Medial branch denervation has shown some promise for the sustained control of lumbar facet joint-mediated pain, but at this time, there is insufficient evidence that it is a wholly efficacious treatment option. Developing a universal algorithm for evaluating facet joint-mediated pain and standard procedural techniques may facilitate the performance of larger outcome studies. This review article provides an overview of the anatomy, pathophysiology, diagnosis, and treatment of facet joint-mediated pain
PMCID:2684949
PMID: 19468914
ISSN: 1935-973x
CID: 106484
Oral Opioid Analgesics vs. Spinal Steroid Injections in the Treatment of Low Back Pain Syndromes
Nampiaparampil, Devi E; Nampiaparampil, Geetha M; Nampiaparampil, Robert G
OBJECTIVE: The aim of this study was to examine the outcomes related to analgesia, function, mortality, and adverse effects of oral opioid analgesics and spinal steroid injections on low back pain syndromes. DESIGN: Databases including Medline, EMBASE, PubMed, and Cochrane Library were searched in September 2009 using combinations of terms related to spinal pain and its treatment. A systematic review was performed of randomized controlled trials that enrolled patients with low back pain syndromes and that evaluated patient outcomes after intervention using either oral opioids or spinal steroid injections. RESULTS: Eight high-quality and ten moderate-quality randomized controlled trials were identified. One high-quality study on oral opioid therapy showed significant improvements in pain relief and patient function. Those on spinal steroid injections had a decreased Visual Analog Scale pain score by 7.18 (95% confidence interval, 2.21-12.1) points more than the control group at 1 mo or less and by 0.429 (95% confidence interval, -4.41 to 5.27) points at 1-3 mos. At more than 6 mos, there was no significant benefit: 0.930 (95% confidence interval, -5.03 to 6.89). Spinal steroids decreased the Oswestry Disability Index by 3.53 (95% confidence interval, 0.480-6.57) at 1 mo or less, by -0.281 (95% confidence interval, -3.18 to 2.62) at 1-3 mos, by -11.0 (95% confidence interval, -14.8 to -7.16) at 3-6 mos, and by -0.205 (95% confidence interval, -3.50 to 3.09) compared with the control group at 6 mos or more, suggesting that there was improvement in function. All-cause mortality was low in our analysis of patients attending specialty clinics. It was difficult to assess the adverse effects of opioid therapy because they influenced up to 28% of patients to withdraw from the original studies. In terms of spinal steroid injections, headache appeared to be the most common adverse effect. However, there was no significantly increased risk of headaches associated with spinal steroids compared with control injections: odds ratio, 1.29 (95% confidence interval, 0.69-2.39). CONCLUSIONS: Oral opioid therapy may be helpful for the treatment of low back pain, but it is unclear from the high-quality literature whether there are limitations from adverse effects. Spinal steroid injections are beneficial for low back pain and disability in the short-term. The high dropout rates caused by insufficient pain relief and adverse effects suggest that opioids may not be as effective as spinal steroid injections. There is more high-quality literature to support the use of spinal steroid injections compared with oral opioids in this condition
PMID: 22037559
ISSN: 1537-7385
CID: 149950
Perioperative Management of Patients Receiving Interventional Techniques and Antiplatelet and Anticoagulant Therapy: A Balancing Act
Manchikanti, Laxmaiah; Kaye, Alan D; Nampiaparampil, Devi E; Sanapati, Mahendra R; Abd-Elsayed, Alaa; Shekoohi, Sahar; Hirsch, Joshua A
PURPOSEOF REVIEW/OBJECTIVE:This article aims to evaluate current evidence and guidelines on anticoagulant and antiplatelet therapy for patients undergoing interventional procedures. It provides recommendations for managing these therapies with either continuation or withholding of these drugs in the perioperative period to minimize the risk of bleeding and thromboembolism in clinical practice. RECENT FINDINGS/RESULTS:Newly published guidelines and research underscore the crucial role of antiplatelet and anticoagulant therapy in interventional procedures, emphasizing the importance of decisions regarding whether to continue or temporarily stop these medications. Studies have categorized procedures into low-, moderate-, and high-risk groups, offering specific guidance on managing anticoagulant and antiplatelet therapy accordingly. The American Society of Interventional Pain Physicians (ASIPP) has developed consensus guidelines based on a synthesis of the best available evidence, incorporating risk stratification and practical recommendations. This review provides an in-depth analysis of medical, surgical, and interventional pain management literature. It highlights the updated ASIPP guidelines and summarizes the society's evidence-based recommendations for clinical practice.
PMID: 40965759
ISSN: 1534-3081
CID: 5935392
Physician Payment Reform in Interventional Pain Management: Balancing Cost, Quality, Access, and Survival of Independent Practices
Manchikanti, Laxmaiah; Sanapati, Mahendra; Pampati, Vidyasagar; Hubbell Iii, Paul J; Conn, Ann; Pasupuleti, Ramarao; Gupta, Mayank; Kaye, Alan D; Abd-Elsayed, Alaa; Navani, Annu; Day, Miles; Nampiaparampil, Devi; Gharibo, Christopher G; Hirsch, Joshua A
On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 Physician Proposed Payment Rule aimed at reducing wasteful spending, enhancing quality measures, improving chronic disease management, and protecting independent practices from systemic financial pressures that have favored large healthcare systems and plagued independent practices. The goals are admirable, but the proposed measures with uniform reductions of 2.5% in physician payments based on efficiency adjustments apply across the board to all physicians. Further, practice expense (PE) reductions of 4% to 6%, meant to apply for hospital-based physicians will inadvertently apply to independent physicians constituting 43% of the physician workforce providing services in ambulatory surgery centers (ASCs), as well as hospitals. Thus, reductions of work relative value unit (wRVU) based on efficiency adjustment of 2.5% and PE reductions of 4% to 6%, with total reductions of 7% to 9%, compromise and limit patient care by putting additional pressure on independent physicians. Further, CMS' proposal to start Ambulatory Specialty Model (ASM) for low back pain with specialties of interventional pain management (IPM) and pain management involved. These specialties have no control over costs incurred as an overwhelming majority of patients are chronic pain patients and managed by family physicians, chiropractors, physical therapists, neurosurgeons, and others, resulting in 9% reductions, or increase in reimbursement over a period of 3 years with recurring changes of 3% each year.The proposal includes a 3.8% conversion factor (CF) payment update and increased reimbursement for office-based services, including evaluation, management, and procedures. The changes will increase reimbursement by 8% to 10% for office-based services, but they also decrease reimbursement for all procedures performed outside offices by 7% to 9%. These proposals arrive at a time when non-physician health care providers are striking for wage increase tied to inflation, and ironically, physicians have experienced repeated cuts in reimbursement with occasional stagnation, leading to 33% reduction from 2001 to 2025 in general, and 41% reductions in reimbursement for interventional pain physicians. In addition, there is an additional 2% sequester cut each year from 2011 to last until 2031, and there is a potential for 4% PAYGO cuts starting next year. Further, supply costs have increased 56% to 80% during these years. Further, despite technological advancements such as EMRs and AI, administrative burdens have intensified rather than improved. Independent physicians contend with complex prior authorizations, evolving Medicare coverage policies, growing audit risk with increased documentation and compliance demands from all payers' sources, 30% of interventional pain physicians under audit at any time. Our data on interventional pain physicians and published data on other physicians shows that efficiency has decreased and PEs have been skyrocketing.Ironically, CMS has proposed on January 10, 2025, a 4.3% payment increase to Medicare Advantage Plans, amounting to $21 billion in 2026. To add fuel to the fire, CMS on April 7, 2025, issued a final rule of increasing on average by 5.06% from 2025 to 2026. These proposals come amid growing concerns about Medicare Advantage over payments, including $44 billion due to favorable selection, $40 billion from risk adjustment discrepancies, and $15 billion for duplicative coverage of veterans who already receive benefits through the Veterans Administration (VA). In addition, according to the Medicare Payment Advisory Commission (MedPAC), traditional Medicare beneficiaries also face higher costs, contributing an additional $198 annually, totaling roughly $13 billion per year. All of these added together, CMS is spending on Medicare Advantage over $110 billion a year.Thus, as independent practice continues to come under assault, the American Society of Interventional Pain Physicians (ASIPP) and other societies urge CMS to create a separate identifier for independent pain physicians to distinguish them from hospital-based physicians and prevent these cuts from harming independent practices. This separate but equal treatment of independent physician practices ultimately interferes with patient care.
PMID: 40986899
ISSN: 2150-1149
CID: 5937672
Diagnostic Guidance for Chronic Complex Regional Pain Syndrome Type I and Type II from The American Society of Interventional Physicians (ASIPP)
Gharibo, Christopher; Day, Miles; Aydin, Steve M; Kaye, Alan D; Abdi, Salahadin; Diwan, Sudhir; Doan, Lisa V; Feng, Danielle; Ferguson, Kris; Georges, Kirolos; Kaufman, Andrew; Knezevic, Nebojsa Nick; Li, Sean; Liongson, Franzes A; Nampiaparampil, Devi; Navani, Annu; Sanapati, Mahendra; Schatman, Michael E; Soin, Amol; Staats, Peter S; Varrassi, Giustino; Wang, Jing; Manchikanti, Laxmaiah
BACKGROUND:Complex Regional Pain Syndrome (CRPS) is a challenging and often disabling condition marked by persistent pain, most commonly in a limb following injury or surgery. It presents with a wide array of symptoms, including intense pain, swelling, alterations in skin color and temperature, motor dysfunction, and trophic changes such as skin and tissue atrophy. While the precise cause of CRPS is not fully understood, it is thought to stem from abnormal nervous system activity, leading to heightened pain sensitivity and inflammatory responses. A thorough understanding of CRPS is essential for accurate diagnosis, effective treatment, and enhancing patients' quality of life.Although attempts have been made to distinguish between acute and chronic CRPS, there are currently no established diagnostic criteria specific to chronic CRPS in medical literature. OBJECTIVE:This ASIPP guidance document offers updated, evidence-based recommendations for the diagnosis and management of Chronic Complex Regional Pain Syndrome (CRPS), with a primary focus on introducing novel, time-based diagnostic criteria specific to the chronic phase. These proposed criteria address significant gaps in the current literature, where existing standards, such as the Budapest Criteria, do not sufficiently differentiate between the acute and chronic stages of the condition. METHODS:An expert panel convened by the American Society of Interventional Pain Physicians (ASIPP) conducted a comprehensive literature review and employed a structured consensus process to develop recommendations. Acknowledging that the clinical and pathological characteristics of CRPS change significantly beyond 12 months, the panel proposed chronic-specific diagnostic criteria based on disease duration, clinical history, physical examination findings, and optional diagnostic tests. These draft criteria were refined through multidisciplinary input and expert consensus. RESULTS:The diagnostic framework for chronic CRPS consists of four key components:General Criteria - Require fulfillment of the Budapest Criteria for at least 12 months, continued recognition of CRPS as a diagnosis of exclusion, and differentiation from generalized nociplastic pain syndromes.History-Based Criteria - Mandate the presence of at least three out of five specific historical features.Physical Examination Criteria - Include asymmetric limb findings, sensory disturbances, and musculoskeletal changes.Optional Diagnostic Testing - May involve assessments such as intraepidermal nerve fiber density (IENFD) and imaging evidence of regional bone demineralization.This framework builds upon the Budapest Criteria by incorporating time-dependent features of chronic CRPS, including musculoskeletal dystrophy, neurogenic inflammation, and sympathetic dysfunction. Emerging objective tools-such as quantitative sensory testing (QST), skin biopsy for IENFD, functional MRI, and serum biomarkers of neuroinflammation-may further support diagnosis in complex or uncertain cases.Treatment recommendations highlight a multimodal strategy that integrates physical rehabilitation, pharmacologic management of neuropathic pain, sympathetic nerve blocks, and advanced neuromodulation. Emphasis is placed on individualized care pathways tailored to disease stage and patient-specific characteristics. CONCLUSIONS:This article presents the first structured, time-sensitive diagnostic criteria for chronic CRPS, aimed at improving diagnostic accuracy and informing treatment strategies. Adoption of these criteria may enhance clinical outcomes and promote further research into the natural history and pathophysiology of CRPS progression.
PMID: 40773629
ISSN: 2150-1149
CID: 5905312
Escalating Growth to Rapid Decline of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain in the Medicare Population: Updated Analysis of the Effect of Multiple Factors from 2000 To 2022
Manchikanti, Laxmaiah; Abd-Elsayed, Alaa; Kaye, Alan D; Pampati, Vidyasagar; Sanapati, Mahendra R; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Soin, Amol; Gharibo, Christopher G; Hirsch, Joshua A
BACKGROUND:The use of facet joint interventions for spinal pain management experienced rapid growth between 2000 and 2010, with an annual increase of 14.2%. However, this trend slowed significantly from 2010 to 2019, with a reduced growth rate of just 2.9% annually. A more recent analysis highlighted a steep decline in facet joint interventions and sacroiliac joint injections, with an overall decrease of 33.2% and an annual decline rate of 12% per 100,000 Medicare beneficiaries between 2019 and 2022. OBJECTIVE:This study aims to update and analyze utilization patterns of facet joint interventions for chronic pain management in the U.S. Medicare population over three periods: 2000-2010, 2010-2019, and 2019-2022. STUDY DESIGN/METHODS:A retrospective cohort study analyzing utilization trends and influencing factors for facet joint interventions in the FFS Medicare population in the United States from 2000 to 2022. METHODS:Data were obtained from the Centers for Medicare & Medicaid Services (CMS) physician/supplier procedure summary database (2000-2022). Utilization rates were calculated based on Medicare beneficiaries for each year and expressed as procedures per 100,000 beneficiaries. Episodes or procedural visits included only primary codes, while services encompassed all procedure levels, including add-on codes. RESULTS:Utilization patterns showed substantial fluctuations. From 2000 to 2010, facet joint intervention rates grew at 14.4% annually, slowing to 2.2% from 2010 to 2019. The COVID-19 pandemic led to a 19.3% decline in episodes. From 2019 to 2022, episodes of facet joint interventions decreased by 21.2% per 100,000 beneficiaries, while the rate of services dropped by 37%, with an annual decrease of 14.3%. Specific declines included lumbar and cervical facet joint injections (38.8% and 40.2%, respectively) and lumbosacral and cervicothoracic facet joint neurolysis (33.6% and 30.8%, respectively). The reduction in facet joint injections and nerve blocks was greater than that observed for neurolytic procedures. LIMITATIONS/CONCLUSIONS:Data were limited to the FFS Medicare population and were available only through 2022, excluding patterns for Medicare Advantage Plans, which covered nearly half of Medicare enrollees in 2022. Additionally, this study shares the common limitations of retrospective claims-based reviews. CONCLUSION/CONCLUSIONS:This retrospective analysis reveals a substantial decline in facet joint intervention episodes, with an overall decrease of 21.2% per 100,000 Medicare beneficiaries and an annual decline rate of 7.6% for episodes from 2019 to 2022.
PMID: 39688820
ISSN: 2150-1149
CID: 5764352
A 24% Decline in the Utilization of Epidural Procedure Visits for Chronic Spinal Pain Management in the Medicare Population from 2019 to 2022: Updated Analysis of the Effect of Multiple Factors
Manchikanti, Laxmaiah; Sanapati, Mahendra R; Pampati, Vidyasagar; Kaye, Alan D; Abd-Elsayed, Alaa; Soin, Amol; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Gharibo, Christopher G; Hirsch, Joshua A
BACKGROUND:The analysis of epidural procedure utilization has revealed several notable trends over recent years. Utilization increased significantly until 2004, then rose minimally until 2011, followed by gradual declines up to 2019 in the Medicare population. The COVID-19 pandemic led to a marked 19% decline in usage from 2019 to 2020. Additionally, recent studies of interventional pain management techniques showed a 28.9% reduction in use from 2019 to 2022, leading to an average annual decline of 10.9%. OBJECTIVE:The present investigation aims to provide an updated evaluation of epidural procedure usage for chronic pain management in the U.S. Medicare population. STUDY DESIGN/METHODS:A retrospective cohort study examining utilization patterns and variables for epidural injections in the fee-for-service (FFS) Medicare population in the U.S. from 2000 to 2022. METHODS:Data was obtained from the Centers for Medicare & Medicaid Services (CMS) master database, specifically using the physician/supplier procedure summary for 2000-2022. Episodes or procedure visits were defined as one per region using primary codes only, while services included all procedure levels and any add-on codes. RESULTS:Between 2000 and 2010, epidural episodes rose by 6.7% annually but then declined by 3% each year from 2010 to 2019. The COVID-19 pandemic led to a 19.3% reduction in procedures from 2019 to 2020, followed by a partial recovery of 5.5% in 2021, then another 10.9% drop in 2022. During 2019-2022, lumbar interlaminar and caudal procedures decreased by 26.9%, while cervical/thoracic interlaminar procedures declined by 24.2%. By 2022, transforaminal procedures surpassed interlaminar procedures, reversing the trend from 2000. LIMITATIONS/CONCLUSIONS:This analysis includes data only through 2022 and is limited to the FFS Medicare population; it does not account for Medicare Advantage Plan enrollees, who made up nearly half of Medicare participants by 2022. Additionally, the study is subject to limitations inherent in retrospective claims data analysis. CONCLUSION/CONCLUSIONS:This two-decade analysis indicates significant shifts in epidural procedure utilization, with steady increases until 2010, followed by a general decline affected by COVID-19 and other contributing factors. An approximate 24% decline in epidural procedure visits for chronic spinal pain management was noted from 2019 to 2022.
PMID: 39688821
ISSN: 2150-1149
CID: 5764362
Exponential Decline of 28.9% in Utilization of Interventional Pain Management Techniques Among Medicare Beneficiaries From 2019 to 2022: Updated Analysis on the Ongoing Effects of COVID-19, Economic Decline, the Affordable Care Act (ACA), and Medical Policies
Manchikanti, Laxmaiah; Pampati, Vidyasagar; Sanapati, Mahendra R; Nampiaparampil, Devi E; Knezevic, Nebojsa Nick; Kaye, Alan D; Soin, Amol; Gharibo, Christopher G; Abd-Elsayed, Alaa; Hirsch, Joshua A
BACKGROUND:Numerous studies have highlighted the escalating costs associated with managing low back and neck pain, as well as other musculoskeletal disorders. In the past, there was a notable increase in the use of interventional techniques to address these disorders. However, the COVID-19 pandemic disrupted various chronic pain treatment approaches, including interventional procedures and opioid use, following a broader trend of reduced healthcare services. Consequently, there was an 18.7% decline in the use of interventional techniques per 100,000 Medicare beneficiaries between 2019 and 2020, a stark contrast to the previous growth patterns, despite some initial declines observed starting in 2017. OBJECTIVES:This analysis aims to provide an updated evaluation of the utilization of interventional techniques for chronic pain management in the U.S. Medicare population. STUDY DESIGN:A retrospective cohort study examining utilization patterns and factors affecting interventional techniques for chronic pain management in the FFS Medicare population in the United States from 2000 to 2022. METHODS:Data for this analysis was obtained from the Centers for Medicare & Medicaid Services (CMS) master database, specifically the physician/supplier procedure summary, spanning the years 2000 to 2022. RESULTS:This retrospective cohort study found that the rate of interventional pain management services per 100,000 Medicare beneficiaries showed a cumulative decline between 2019 and 2022 of 28.9%, with an annual decrease of 10.7%. This contrasts sharply with the 2010-2019 period, which saw a small annual decline of 0.4%. Particularly significant was the sharp reduction of 18.7% from 2019 to 2020, coinciding with the pandemic. From 2020 to 2021, the decline slowed to 1.1%, before accelerating again with an 11.5% drop between 2021 and 2022. LIMITATIONS:Data were available only through 2022 and were limited to the FFS Medicare population; utilization patterns for Medicare Advantage Plans, which accounted for nearly 50% of Medicare enrollment in 2022, were not included. Additionally, this analysis shares the inherent limitations of all retrospective reviews based on claims data. CONCLUSION:This retrospective analysis demonstrates a significant reduction in the use of interventional pain management techniques from 2019 to 2022. Contributing factors to this decline likely include the lasting effects of COVID-19, economic challenges, the Affordable Care Act (ACA), and evolving local coverage determination policies.
PMID: 39621971
ISSN: 2150-1149
CID: 5763682
Comprehensive Evidence-Based Guidelines for Implantable Peripheral Nerve Stimulation (PNS) in the Management of Chronic Pain: From the American Society Of Interventional Pain Physicians (ASIPP)
Manchikanti, Laxmaiah; Sanapati, Mahendra R; Soin, Amol; Kaye, Alan D; Kaye, Adam M; Solanki, Daneshvari R; Chen, Grant H; Nampiaparampil, Devi; Knezevic, Nebojsa Nick; Christo, Paul; Bautista, Alexander; Karri, Jay; Shah, Shalini; Helm Ii, Standiford; Navani, Annu; Wargo, Bradley W; Gharibo, Christopher G; Rosenblum, David; Luthra, Komal; Patel, Kunj G; Javed, Saba; Reuland, Warren; Gupta, Mayank; Abd-Elsayed, Alaa; Limerick, Gerard; Pasupuleti, Ramarao; Schwartz, Gary; Chung, Matthew; Slavin, Konstantin V; Pampati, Vidyasagar; Hirsch, Joshua A
BACKGROUND:Peripheral nerve stimulation (PNS) has been used for over 50 years to treat chronic pain by delivering electrical pulses through small electrodes placed near targeted peripheral nerves those outside the brain and spinal cord. Early PNS systems often required invasive neurosurgical procedures. However, since 2015, the Food and Drug Administration (FDA) approved percutaneously implanted PNS leads and neurostimulators offering a much less invasive, non-opioid option for managing recalcitrant chronic pain. The following FDA-cleared PNS systems are commercially available in the United States for the management of chronic, intractable pain:• Freedom® Peripheral Nerve Stimulator (PNS) System (Curonix LLC, 2017) • StimRouter® Neuromodulation System (Bioness, now Bioventus, 2015)• SPRINT® PNS System (SPR® Therapeutics, Inc., 2016) • Nalu™ Neurostimulation System (Nalu Medical Inc., 2019)• ReActiv8® Implantable Neurostimulation System (Mainstay Medical Limited, 2020) The American Society of Interventional Pain Physicians (ASIPP) has published evidence-based consensus guidelines for the application of PNS systems in managing chronic pain. OBJECTIVE:The guidelines aim to provide evidence-based recommendations for the utilization of peripheral nerve stimulation (PNS) in the management of moderate to severe chronic pain. These guidelines exclude field stimulation, or sacral nerve stimulation. METHODS:A multidisciplinary panel of experts in various medical and pharmaceutical fields, convened by ASIPP, reviewed the evidence, considered patient perspectives, and formulated recommendations for implantable peripheral nerve stimulation in chronic pain management. The methodology included developing key questions with evidence-based statements and recommendations. The grading of evidence and recommendations followed a modified approach described by ASIPP, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method, and the Agency for Healthcare Research and Quality (AHRQ) strength of recommendations methods. The evidence review includes existing guidelines, systematic reviews, comprehensive reviews, randomized controlled trials (RCTs), and observational studies on the effectiveness and safety of implantable peripheral nerve stimulation in managing chronic pain. The quality of published studies was assessed using appropriate instruments for systematic reviews, RCTs, and observational studies.In the development of consensus statements and guidelines, we used a modified Delphi technique, which has been described to minimize bias related to group interactions. Panelists without a primary conflict of interest voted to approve specific guideline statements. Each panelist could suggest edits to the guideline statement wording and could suggest additional qualifying remarks or comments as to the implementation of the guideline in clinical practice to achieve consensus and for inclusion in the final guidelines, each guideline statement required at least 80% agreement among eligible panel members without primary conflict of interest. RESULTS:A total of 31 authors participated in the development of these guidelines. Of these, 23 participated in the voting process. A total of 8 recommendations were developed. Overall, 100% acceptance was obtained for 8 of 8 items. Thus, with appropriate literature review, consensus-based statements were developed for implantable peripheral nerve stimulation in chronic pain management. In preparation of these guidelines, evidence synthesis included 7 systematic reviews, 8 RCTs, and 9 observational studies covering all PNS treatments. The evidence was developed using GRADE criteria or certainty of evidence, and qualitative synthesis based on the best available evidence. The evidence level and recommendations are as follows: For implantable peripheral nerve stimulation systems following a trial or selective lumbar medial branch stimulation without a trial, the evidence is Level III or fair with moderate certainty. Evidence Level: Fair; Strength of Recommendation: ModerateFor temporary peripheral nerve stimulation for 60 days, the evidence is Level III or fair, with moderate certainty. EVIDENCE LEVEL/METHODS:Fair; Strength of Recommendation: ModerateBased on the available evidence, it is our recommendation to expand the existing PNS related local coverage determination (LCD) to include craniofacial pain, phantom limb pain, and nociceptive pain in the lower back as present evidence shows Level III or fair with moderate certainty. LIMITATIONS/CONCLUSIONS:The primary limitation of these guidelines is the paucity of the available literature. CONCLUSION/CONCLUSIONS:These evidence-based guidelines support the use of implantable peripheral nerve stimulation leads and neurostimulators in patients with moderate to severe chronic pain refractory to two or more conservative treatments. These guidelines aim to optimize patient outcomes and promote health equity through the integration of PNS technology in clinical practice.
PMID: 39565237
ISSN: 2150-1149
CID: 5758552