Pacific Spine and Pain Society (PSPS) Evidence Review of Surgical Treatments for Lumbar Degenerative Spinal Disease: A Narrative Review.

INTRODUCTION: Interventional treatment options for the lumbar degenerative spine have undergone a significant amount of innovation over the last decade. As new technologies emerge, along with the surgical specialty expansion, there is no manuscript that utilizes a review of surgical treatments with evidence rankings from multiple specialties, namely, the interventional pain and spine communities. Through the Pacific Spine and Pain Society (PSPS), the purpose of this manuscript is to provide a balanced evidence review of available surgical treatments. METHODS: The PSPS Research Committee created a working group that performed a comprehensive literature search on available surgical technologies for the treatment of the degenerative spine, utilizing the ranking assessment based on USPSTF (United States Preventative Services Taskforce) and NASS (North American Spine Society) criteria. RESULTS: The surgical treatments were separated based on disease process, including treatments for degenerative disc disease, spondylolisthesis, and spinal stenosis. CONCLUSIONS: There is emerging and significant evidence to support multiple approaches to treat the symptomatic lumbar degenerative spine. As new technologies become available, training, education, credentialing, and peer review are essential for optimizing patient safety and successful outcomes.

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs.

The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.

Paroxysmal dyskinesia and electrodermal volatility: The role of mindfulness, self-compassion and psychophysiological interventions.

To date, there are no behavioral or psychophysiological treatment studies on paroxysmal dyskinesia (PD). PD is a group of debilitating movement disorders that present with severe episodes of dystonia, chorea, and/or ballistic like movements. This is a first case report of a 50-year-old male who received behavioral interventions (e.g., mindfulness, CBT, and biofeedback interventions) to manage his PD episodes in tandem with multidisciplinary treatments (e.g., neurology, psychiatry, etc.). The paper primarily discusses the serendipitous observation of galvanic skin response (GSR) elevations and spikes immediately before and after the onset of PD episodes. GSR volatility was noted in wave amplitude and wave morphology. Graphs are presented to illustrate GSR volatility associate with PD episodes and the reduction of GSR volatility in response to behavioral approaches. The discussion highlights the feasibility of using GSR biofeedback as an adjunct to mindfulness and CBT to manage PD as part of a multidisciplinary treatment approach. Peripherally, issues that related to misclassification of somatic symptoms and related disorders (e.g., psychogenic non-epileptic seizures) and aspects of neurocognitive disorders are discussed. The paper reviews neurological findings, MRI, neuropsychological data, and psychiatric assessment to highlight the dilemma clinician's face and clarify behavioral practices to further the management of PD.

Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience.

Chronic low back pain is a worldwide leading cause of pain and disability. Degenerative disc disease has been the presumptive etiology in the majority of cases of chronic low back pain (CLBP). More recent study and treatments have discovered that the vertebral endplates play a large role in CLBP in a term defined as vertebrogenic back pain. As the vertebral endplates are highly innervated via the basivertebral nerve (BVN), this has resulted in a reliable target in treating patients suffering from vertebrogenic low back pain (VLBP). The application of BVN ablation for patients suffering from VLBP is still in its early stages of adoption and integration into spine care pathways. BVN ablation is grounded in a solid foundation of both pre-clinical and clinical evidence. With the emergence of this therapeutic option, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidelines for the proper identification and selection of patients for BVN ablation in patients with VLBP. ASPN formed a multidisciplinary work group tasked to examine the available literature and form best practice guidelines on this subject. Based on the United States Preventative Task Force (USPSTF) criteria for grading evidence, gives BVN ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals.

Restorative Neurostimulation: A Clinical Guide for Therapy Adoption.

In this review, we present a comprehensive clinical approach to restorative neurostimulation, a novel form of stimulation for refractory chronic mechanical low back pain, targeting impaired neuromuscular control and degeneration of the multifidus muscle. We focus on patient identification, technique guidance, and review of the scientific background and clinical evidence. As our understanding of back pain grows, there is clear evidence that impaired neuromuscular control and consequent degeneration of the multifidus muscle contribute to mechanical low back pain development and maintenance. We provide clinical guidance regarding an implantable restorative neurostimulation system that targets impaired neuromuscular control. Supported by results from a randomized, active-sham-controlled clinical trial with long-term follow-up, we provide clinicians with a comprehensive overview and practical clinical guidance for the adoption of this therapy modality.

60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief.

Objective: Conventional neurostimulation typically involves a brief (eg, ≤10-day) trial to assess presumed effectiveness prior to permanent implantation. Low trial conversion rates and high explant rates due to inadequate pain relief highlight the need for improved patient identification strategies. The development of a 60-day percutaneous peripheral nerve stimulation (PNS) system enables evaluation of outcomes following an extended temporary treatment period of up to 60 days, that may obviate or validate the need for permanent implant. The present study provides the first real-world evidence regarding patient response throughout a 60-day PNS treatment period. Methods: Anonymized data listings were compiled from patients who underwent implantation of temporary percutaneous leads and opted-in to provide real-world data to the device manufacturer during routine interactions with device representatives throughout the 60-day treatment. Results: Overall, 30% (222/747) of patients were early responders (≥50% pain relief throughout treatment). Another 31% (231/747) of patients initially presented as non-responders but surpassed 50% pain relief by the end of treatment. Conversely, 32% (239/747) of patients were non-responders throughout treatment. An additional 7% (55/747) of patients initially presented as responders but fell below 50% relief by the end of the treatment period. Conclusion: An extended, 60-day PNS treatment may help identify delayed responders, providing the opportunity for sustained relief and improving access to effective PNS treatment. Compared to a conventionally short trial of ≤10 days, a longer 60-day PNS treatment may also help reduce explant rates by identifying delayed non-responders unlikely to benefit long-term. These scenarios support the importance of an extended 60-day temporary PNS stimulation period to help inform stepwise treatment strategies that may optimize outcomes and cost-effectiveness.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulation.

INTRODUCTION: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based on their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant. RESULTS: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion. CONCLUSIONS: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community.

Strategic testing plan for ambulatory surgery centers after the COVID-19 pandemic.

As the curve continues to flatten during the severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic, and more physicians resume outpatient clinical work, the question arises of how to ensure the safety of the patients and staff while performing cases. Many institutions and health-care offices have turned to screening questionnaires to determine the likelihood of coronavirus disease 2019 (COVID-19) positivity. However, screening questionnaires are woefully inadequate as studies have shown that roughly 6.4% to 50% of patients may spread this virus without any symptoms. In this study, we have outlined a proposal to restart elective procedures after the curve has flattened in a certain locale, particularly for ambulatory surgery centers (ASCs). Until additional data are collected for specific sensitivity and specificity values for PCR testing, we recommend performing 2 consecutive polymerase chain reaction (PCR) tests to minimize false negative rates. The algorithm described in this study can help ASCs begin their practices and provide local public health officials with valuable data that can help establish true sensitivity and specificity rates for these tests.

Efficacy of Serology Testing in Predicting Reinfection in Patients With SARS-CoV-2.

In many parts of the United States, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases have reached peak infection rates, prompting administrators to create protocols to resume elective cases. As elective procedures and surgeries get scheduled, ambulatory surgery centers (ASCs) must implement some form of widespread testing in order to ensure the safety of both the ASC staff and the patients being seen. The US Centers for Disease Control and Prevention (CDC) recently announced the approval of new serological testing for SARS-CoV-2, a test that can indicate the presence of IgM and IgG antibodies in the serum against viral particles. However, the possibility for reinfection raises questions about the utility of this new serological test, as the presence of IgG may not correspond to long-term immunity. SARS-CoV-2 has been known to form escape mutations, which may correspond to a reduction in immunoglobulin binding capacity. Patients who develop more robust immune responses with formation of memory CD8+ T-cells and helper CD4+ T-cells will be the most equipped if exposed to the virus, but, unfortunately, the serology test will not help us in distinguishing those individuals. Given the inherent disadvantages of serological testing, antibody testing alone should not be used when deciding patient care and should be combined with polymerase chain reaction testing.

Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Advancing Simulation-Based Education in Pain Medicine.

Background: The Accreditation Council for Graduate Medical Education (ACGME) has recently implemented milestones and competencies as a framework for training fellows in Pain Medicine, but individual programs are left to create educational platforms and assessment tools that meet ACGME standards. Objectives: In this article, we discuss the concept of milestone-based competencies and the inherent challenges for implementation in pain medicine. We consider simulation-based education (SBE) as a potential tool for the field to meet ACGME goals through advancing novel learning opportunities, engaging in clinically relevant scenarios, and mastering technical and nontechnical skills. Results: The sparse literature on SBE in pain medicine is highlighted, and we describe our pilot experience, which exemplifies a nascent effort that encountered early difficulties in implementing and refining an SBE program. Conclusions: The many complexities in offering a sophisticated simulated pain curriculum that is valid, reliable, feasible, and acceptable to learners and teachers may only be overcome with coordinated and collaborative efforts among pain medicine training programs and governing institutions.

Fibromyalgia.

Questions from patients about pain conditions and analgesic pharmacotherapy and responses from authors are presented to help educate patients and make them more effective self-advocates. In reply to a question about fibromyalgia, the authors discuss symptoms, the use of opioids and naltrexone, other medication and nonmedication options, and managing expectations for treatment.

Methadone for Pain Relief.

Questions from patients about pain conditions and analgesic pharmacotherapy and responses from authors are presented to help educate patients and make them more effective self-advocates. In reply to a question, the authors discuss the use of methadone for pain management, outline how the body processes methadone, list interactions and side effects, and emphasize the importance of taking the medication as prescribed.