The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-term Outcome Optimization and Salvage Therapy.

INTRODUCTION: The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices. MATERIALS AND METHODS: The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue. In addition, the faculty was chosen in consideration of diversity and inclusion of different career paths and demographic categories. Once chosen, the faculty was asked to grade current evidence and along with expert opinion create consensus recommendations to address the lapses in information on this topic. RESULTS: The NACC® group established informative and authoritative recommendations on the salvage and optimization of care for those with indwelling devices. The recommendations are based on evidence and expert opinion and will be expected to evolve as new data are generated for each topic. CONCLUSIONS: NACC® guidance should be considered for any patient with less-than-optimal outcomes with a stimulation device implanted for treating chronic pain. Consideration should be given to these consensus points to salvage a potentially failed device before explant.

The role of endogenous opioids in mindfulness and sham mindfulness-meditation for the direct alleviation of evoked chronic low back pain: a randomized clinical trial.

Chronic low back pain (cLBP) is the most prevalent chronic pain condition. There are no treatments that haven been found to directly assuage evoked cLBP. To this extent, mindfulness-meditation is a promising pain therapy. Yet, it is unclear if meditation can be utilized to directly attenuate evoked chronic pain through endogenous opioids. A double-blind, randomized, and placebo-controlled clinical trial with a drug crossover design examined if mindfulness-meditation, as compared to sham mindfulness-meditation, attenuated straight leg-raise test evoked chronic pain during intravenous (0.15 mg/kg bolus + 0.15 mg/kg/hour maintenance) naloxone (opioid antagonist) and placebo-saline infusion. Fifty-nine individuals with cLBP (mean age = 46 years; 30 females) completed all study procedures. After the pre-intervention pain testing session, patients were randomized to a four-session (20-min/session) mindfulness (n = 30) or sham mindfulness-meditation (n = 29) intervention. After the interventions, mindfulness and sham mindfulness-meditation were associated with significant reductions in back pain during saline and naloxone infusion when compared to rest (non-meditation) in response to the cLBP-evoking straight leg-raise test. These results indicate that meditation directly reduces evoked chronic pain through non-opioidergic processes. Importantly, after the interventions, the mindfulness group reported significantly lower straight leg-raise induced pain than the sham mindfulness-meditation group during rest (non-meditation) and meditation. Mindfulness and sham mindfulness-meditation training was also associated with significantly lower Brief Pain Inventory severity and interference scores. The pain-relieving effects of mindfulness meditation were more pronounced than a robust sham-mindfulness meditation intervention, suggesting that non-reactive appraisal processes may be uniquely associated with improvements in chronic low-back pain.Trial Registration: ClinicalTrials.gov identifier: NCT04034004.

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.

Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations.

Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation period (SCSeval) before permanent implantation. We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, and outcomes collection during their surgical journey. We analyzed preoperative patient demographics, characterized patient pain profiles using the patient-reported outcomes measurement information system-29 surveys, and calculated the rates of conversion from temporary to permanent spinal cord stimulation (SCS) implantation. Between August 1, 2021, and March 2, 2023, 7,000 patients (mean age 59.1, 59.6% female) underwent SCSeval procedures while utilizing a mobile application. Patients commonly experienced aching, sharp, stabbing, tingling, numb, and burning pain. Patients had tried multiple prior therapies and wanted to reduce their use of opioids and pain medications. Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those who underwent SCSeval in a hospital setting. There was a significant improvement in all domains of pain as evaluated by pre and postoperative patient-reported outcomes measurement information system-29 surveys. This study supports the use of digital health technology as part of the SCS journey to improve the patient experience and allow for robust patient-reported outcomes collection. The overall rate of SCSeval to permanent SCS in our study of 72.4% was higher than national rates of 64%, suggesting that an app may allow clinicians to better quantify changes in chronic pain and provide more insight into choosing to implant SCS permanently. PERSPECTIVE: This article presents real-world evidence from a digital health platform for therapy education and outcomes collection from patients undergoing spinal cord stimulation evaluation procedures. Such tools could allow for better pain characterization and allow for more nuanced tracking of patient outcomes among those with chronic pain.

Complex Regional Pain Syndrome: Evidence-Based Advances in Concepts and Treatments.

PURPOSE OF REVIEW: This review presents the most current information about the epidemiology of complex regional pain syndrome (CRPS), classification and diagnostic criteria, childhood CRPS, subtypes, pathophysiology, conventional and less conventional treatments, and preventive strategies. RECENT FINDINGS: CRPS is a painful disorder with multifactorial pathophysiology. The data describe sensitization of the central and peripheral nervous systems, inflammation, possible genetic factors, sympatho-afferent coupling, autoimmunity, and mental health factors as contributors to the syndrome. In addition to conventional subtypes (type I and type II), cluster analyses have uncovered other proposed subtypes. Prevalence of CRPS is approximately 1.2%, female gender is consistently associated with a higher risk of development, and substantial physical, emotional, and financial costs can result from the syndrome. Children with CRPS seem to benefit from multifaceted physical therapy leading to a high percentage of symptom-free patients. The best available evidence along with standard clinical practice supports pharmacological agents, physical and occupational therapy, sympathetic blocks for engaging physical restoration, steroids for acute CRPS, neuromodulation, ketamine, and intrathecal baclofen as therapeutic approaches. There are many emerging treatments that can be considered as a part of individualized, patient-centered care. Vitamin C may be preventive. CRPS can lead to progressively painful sensory and vascular changes, edema, limb weakness, and trophic disturbances, all of which substantially erode healthy living. Despite some progress in research, more comprehensive basic science investigation is needed to clarify the molecular mechanisms of the disease so that targeted treatments can be developed for better outcomes. Incorporating a variety of standard therapies with different modes of action may offer the most effective analgesia. Introducing less conventional approaches may also be helpful when traditional treatments fail to provide sufficient improvement.

Best Practices for Dorsal Root Ganglion Stimulation for Chronic Pain: Guidelines from the American Society of Pain and Neuroscience.

With continued innovations in neuromodulation comes the need for evolving reviews of best practices. Dorsal root ganglion stimulation (DRG-S) has significantly improved the treatment of complex regional pain syndrome (CRPS), and it has broad applicability across a wide range of other conditions. Through funding and organizational leadership by the American Society for Pain and Neuroscience (ASPN), this best practices consensus document has been developed for the selection, implantation, and use of DRG stimulation for the treatment of chronic pain syndromes. This document is composed of a comprehensive narrative literature review that has been performed regarding the role of the DRG in chronic pain and the clinical evidence for DRG-S as a treatment for multiple pain etiologies. Best practice recommendations encompass safety management, implantation techniques, and mitigation of the potential complications reported in the literature. Looking to the future of neuromodulation, DRG-S holds promise as a robust intervention for otherwise intractable pain.

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain.

Introduction: Painful lumbar spinal disorders represent a leading cause of disability in the US and worldwide. Interventional treatments for lumbar disorders are an effective treatment for the pain and disability from low back pain. Although many established and emerging interventional procedures are currently available, there exists a need for a defined guideline for their appropriateness, effectiveness, and safety. Objective: The ASPN Back Guideline was developed to provide clinicians the most comprehensive review of interventional treatments for lower back disorders. Clinicians should utilize the ASPN Back Guideline to evaluate the quality of the literature, safety, and efficacy of interventional treatments for lower back disorders. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations. Experts from the fields of Anesthesiology, Physiatry, Neurology, Neurosurgery, Radiology, and Pain Psychology developed the ASPN Back Guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for back-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using United States Preventive Services Task Force (USPSTF) criteria and consensus points are presented. Results: After a comprehensive review and analysis of the available evidence, the ASPN Back Guideline group was able to rate the literature and provide therapy grades to each of the most commonly available interventional treatments for low back pain. Conclusion: The ASPN Back Guideline represents the first comprehensive analysis and grading of the existing and emerging interventional treatments available for low back pain. This will be a living document which will be periodically updated to the current standard of care based on the available evidence within peer-reviewed literature.

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation.

Peripheral nerve stimulation is an established treatment modality for chronic neuropathic pain. Over the last decade, with the advent of innovative devices and delivery platforms, peripheral nerve stimulation has evolved from invasive open surgeries to image-guided, minimally invasive percutaneous procedures. The authors hereby present a novel device, the Nalu™ Neurostimulation System (Nalu Medical, CA, USA), which has established its advantages in providing predictable and reliable peripheral nerve stimulation therapy for chronic neuropathic pain management. This novel device is effective in treating chronic pain conditions such as post-herniorrhaphy pain syndrome, intercostal neuralgia, post-laminectomy syndrome, and complex regional pain syndrome and holds great promise for the treatment of peripheral neuropathic pain.

Chronic nerve pain is a debilitating condition that can affect quality of life and functioning. The Nalu™ Neurostimulation System (Nalu Medical, CA, USA) provides long-term pain relief without medications. There are numerous devices currently available that can be utilized to block pain signals using small wires. This system is unique because the wires placed over affected nerves are powered by an external battery that does not require permanent surgical implantation. Pain after hernia surgery, back surgery, hip surgery and knee surgery, as well as nerve pain can be effectively managed by this system.

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.

Radiofrequency Ablation for the Knee Joint: A Survey by the American Society of Pain and Neuroscience.

Background: Genicular nerve radiofrequency ablation (RFA) is an effective, minimally invasive procedure often used to treat patients with intractable knee pain secondary to knee osteoarthritis and failed knee replacements. The prevalence of knee pain in adults has been estimated to be as high as 40% and is continuously increasing with an aging population. Over the past two decades, proceduralists have adopted variations in patient preparation, procedural steps, and post-operative care for genicular nerve RFA procedures. A survey was dispensed via the American Society of Pain and Neuroscience (ASPN) to gain a popular assessment of common practices for genicular nerve RFA. Methods: A 29 question survey was dispensed via SurveyMonkey to all members of ASPN. Members were able to respond to the survey a single time and were unable to make changes to their responses once the survey was submitted. After responses were compiled, each question was assessed in order to determine common practices for genicular nerve RFA. Results: A total of 378 proceduralists responded to the survey. There was high consensus with the three most commonly targeted nerves. The inferomedial, superomedial, and superolateral genicular branches were treated by 95-96% of respondents, while other targets were less commonly treated. There remains some debate among proceduralists regarding the need for a second diagnostic nerve block and the type of steroid used for diagnostic nerve blocks. Conclusion: Pain physicians use a wide variety of methods to perform genicular nerve ablations. The data offered by the survey show that there is no standardized protocol when it comes to treating knee pain via genicular nerve block and ablation and highlights controversies among proceduralists that ought to serve as the targets of future clinical research aimed at establishing a standardized protocol.

A Clinical Feasibility Study of Spinal Evoked Compound Action Potential Estimation Methods.

OBJECTIVES: Spinal cord stimulation (SCS) is a treatment for chronic neuropathic pain. Recently, SCS has been enhanced further with evoked compound action potential (ECAP) sensing. Characteristics of the ECAP, if appropriately isolated from concurrent stimulation artifact (SA), may be used to control, and aid in the programming of, SCS systems. Here, we characterize the sensitivity of the ECAP growth curve slope (S) to both neural response (|Sresp|) and SA contamination (|Sart|) for four spinal ECAP estimation methods with a novel performance measure (|Sresp/Sart|). MATERIALS AND METHODS: We collected a library of 112 ECAP and associated artifact recordings with swept stimulation amplitudes from 14 human subjects. We processed the signals to reduce SA from these recordings by applying one of three schemes: a simple high-pass (HP) filter, subtracting an artifact model (AM) consisting of decaying exponential and linear components, or applying a template correlation method consisting of a triangularly weighted sinusoid. We compared these against each other and to P2-N1, a standard method of measuring ECAP amplitude. We then fit the ECAP estimates from each method with a function representing the growth curve and calculated the Sresp and Sart parameters following the fit. RESULTS: Any SA reduction scheme selected may result in under- or overestimation of neural activation or misclassification of SA as ECAP. In these experiments, the ratio of neural signal preservation to SA misclassification (|Sresp/Sart|) on the ECAP estimate was superior (p < 0.05) with the HP and AM schemes relative to the others. CONCLUSIONS: This work represents the first comprehensive assessment of spinal ECAP estimation schemes. Understanding the clinically relevant sensitivities of these schemes is increasingly important, particularly with closed-loop SCS systems using ECAP as a feedback control variable where misclassification of artifact as neural signal may lead to suboptimal therapy adjustments.

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.

Reducing opioid usage in total knee arthroplasty postoperative pain management: a literature review and future directions.

Total knee arthroplasty (TKA) is a common orthopedic surgery performed with a projected 3.5 million procedures to be done by 2030. Current postoperative pain management for TKA is insufficient, as it results in extensive opioid consumption and functional decline postoperatively. This study identifies the best practices for postoperative TKA pain management through a literature review of the last three years. Studies utilizing interventional techniques (local infiltration analgesia, nerve blocks) and pharmacologic options were reviewed on PubMed, Embase, Ovid Medline and Scopus. Primary outcomes analyzed were the effect of different analgesic approaches on pain reduction, opioid use reduction and improvements in functional mobility or quadriceps strength postoperatively. Additionally, this paper explores the use of cooled radiofrequency ablation, a minimally invasive therapy, for preoperative and postoperative TKA pain management.

Lay abstract Total knee arthroplasty (TKA), also known as 'knee replacement', is a common orthopedic surgery performed with a projected 3.5 million procedures to be done by 2030. Historically, pain management after TKA has involved opioids, but in light of recent extensive opioid dependence and consumption, pain management plans that incorporate other non-opioid techniques should be considered. This study identifies the best practices for postoperative TKA pain management through a literature review of the last 3 years. Studies utilizing interventional techniques such as local analgesia and nerve blocks, as well as pharmacologic options (involving the administration of medicines), were reviewed on the following databases: PubMed, Embase, Ovid Medline and Scopus. The main outcomes analyzed were the effect of these different approaches on pain reduction, opioid use reduction and improvements in functional mobility or strength of the quadriceps muscle in the thigh following TKA surgery. Additionally, this paper explores the use of cooled radiofrequency ablation, a minimally invasive therapy, for preoperative and postoperative TKA pain management.

Recommendations for anesthetic management for intraoperative neuromodulation cases.

This paper performs a review of current literature as well as uses our single-center experience to discuss pre-operative, intra-operative and, briefly, postoperative management for dorsal column stimulators (DCSs), dorsal root ganglion (DRG) stimulators, peripheral nerve stimulators (PNSs) and intrathecal pumps. Generally, pre-operative antibiotics are recommended with discontinuation within 24 h postoperatively. For dorsal column and DRG stimulation, monitored anesthesia care or general anesthesia with intra-operative neuromonitoring is recommended; for peripheral nerve stimulation and intrathecal pump implementation, monitored anesthesia care is preferred. There is little information on appropriate anesthetic management during these forms of neuromodulation. More research is necessary to articulate specific pre-operative, intra-operative and postoperative management guidelines and recommendations for dorsal column stimulator, DRG stimulation, PNS and intrathecal pump implantation.

Neuromodulation is a procedure wherein the nerves that are responsible for pain are stimulated, for example with electrical pulses, to reduce the pain signals originating from that nerve. The implantation of neuromodulation devices requires surgery. This paper reviews current literature and provides guidelines based on our single center experience to discuss anesthetic management of patients before surgery, during surgery and after the surgery. We review management for different forms of neuromodulation including dorsal column stimulators (DCSs), dorsal root ganglion (DRG) stimulators, peripheral nerve stimulators and intrathecal pumps. We searched various online databases to find papers that discussed anesthetic management around these surgeries. Generally, starting antibiotics before the surgery and then stopping the antibiotics within 24 h after the surgery is recommended. For dorsal column and DRG stimulation, monitored anesthesia care, where patients are awake but very relaxed, or general anesthesia with neuromonitoring during the operation (so that surgeons can check the function of the nerves in real time) is recommended. For peripheral nerve stimulation and intrathecal pump implementation, monitored anesthesia care is preferred. There is little information in the literature on appropriate anesthetic management during these forms of neuromodulation. More research is necessary to articulate specific management guidelines before surgery, during surgery and after surgery for DCSs, DRG stimulation, peripheral nerve stimulator and intrathecal pump implantation.

How Well Do Current Laboratory Biomarkers Inform Clinical Decision-Making in Chronic Pain Management?

OBJECTIVE: Decision-making in chronic pain patients involves a combination of subjective and objective criteria, including patient history, physical examination, imaging, and patient response to prior treatments, clinical experience, probabilities, and recognition of patterns. However, there is a distinct lack of objective laboratory biomarkers in use in routine clinical care. The objective was to review the literature to identify and describe specific biomarkers in chronic pain management. METHODS: This is a narrative review of the literature regarding the use of laboratory biomarkers in chronic pain. A librarian-assisted literature search of the PubMed, Science Direct, and Google Scholar databases was performed and resulted in 304 possible manuscripts. We included manuscripts assessing laboratory collected biomarkers from urine, serum, cerebrospinal fluid, and saliva. After screening and review of the initial literature search results, a total of 75 manuscripts were included in the narrative review. CONCLUSION: The studies reviewed suggested that specific biomarkers may help identify those patients at risk of disease development and function as a prognostic indicator for disease progression and treatment response. However, additional research is necessary before specific recommendations can be made, and current clinical decision-making is modified.

Interventional Spine and Pain Procedure Credentialing: Guidelines from the American Society of Pain & Neuroscience.

BACKGROUND: The discipline of interventional pain management has changed significantly over the past decade with an expected greater evolution in the next decade. Not only have the number of procedures increased, some of the procedures that were created for spine surgeons are becoming more facile in the hands of the interventional pain physician. Such change has outpaced academic institutions, societies, and boards. When a pain physician is in the credentialing process for novel procedure privileges, it can leave the healthcare system in a challenging situation with little to base their decision upon. METHODS: This paper was developed by a consensus working group from the American Society of Pain and Neuroscience from various disciplines. The goal was to develop processes and resources to aid in the credentialing process. RESULTS: These guidelines from the American Society of Pain and Neuroscience provide background information to help facilities create a process to appropriately credential physicians on novel procedures. They are not intended to serve as a standard or legal precedent. CONCLUSION: This paper serves as a guide for facilities to credential physicians on novel procedures.