Treatment Options for Failed Back Surgery Syndrome Patients With Refractory Chronic Pain: An Evidence Based Approach.

STUDY DESIGN: A significant number of lumbar postsurgical patients continue to suffer persistent pain and limited function and are termed to have "Failed back surgery syndrome" (FBSS). This review evaluates clinical trial data for the treatment of FBSS patients. OBJECTIVE: Using an evidence-based approach to evaluate FBSS treatments will assist clinicians in choosing the most effective options for FBSS patients. Furthermore, reducing the utilization of less effective therapies may result in substantial financial savings for this patient population. SUMMARY OF BACKGROUND DATA: Treatments for FBSS may be generally categorized as physical therapy and exercise, medications, interventional procedures, neuromodulation, and reoperation. Careful review and classification of the level of evidence available for each category of treatment for FBSS patients will help guide clinical decision-making. METHODS: A literature review was performed for FBSS treatments. The publications were arranged hierarchically according to the North American Spine Society's guidelines as randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, and expert opinions were excluded. The review focused on studies with at least 20 FBSS patients and 6-month follow-up. RESULTS: Evidence is weak for medications and reoperation, but strong for active exercise and interventional procedures such as adhesiolysis. The strongest evidence for long-term treatment is for spinal cord stimulation (SCS), showing favorable Level I RCT results compared with conventional medical management and reoperation. In addition, high-frequency SCS at 10 kHz has demonstrated superiority over traditional, low-frequency SCS for treating low back and leg pain in a recent Level I RCT. CONCLUSION: Clinicians may increasingly utilize levels of evidence during their evaluation of each FBSS patient to render the best therapeutic plan, likely resulting in improved long-term pain control and reducing costs by avoiding less effective modalities. New directions in SCS show promising results for the treatment of FBSS. LEVEL OF EVIDENCE: 1.

Reinstituting the Bolus - New Reasoning for an Existing Technique.

Improved intrathecal (IT) pump technology is increasing the accuracy of IT opioid bolus dosing and promising advances in pain therapy. Opioid bolus dosing can be used with a minimal continuous infusion or it can function as the sole therapy. Bolus-only dosing is characterized by minimal use of opioid (often less than 1 mg of IT morphine). It achieves adequate pain control while reducing tolerance and possibly opioid-induced hyperalgesia. It may prevent receptor saturation, and provide a "washing out" of the opioid receptor that prevents the observed dose escalation resulting from continuous infusions. With new bolus dosing possibilities, IT pumps can be used earlier in the treatment algorithm instead of being a late-stage treatment for patients who responded poorly to conservative treatments. We hypothesize that morphine bolus-only IT dosing will have comparable adverse effect rates, and possibly increased safety as compared to the more conservative continuous delivery method. We further predict that bolus-only delivery will provide better therapy satisfaction, improved functional scores, lower 24 hour opioid dose, and less dose escalation.

The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

INTRODUCTION: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice. METHODS: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012. An extensive literature search identified publications between January 15, 2007 and November 22, 2015 and authors contributed additional relevant sources. After reviewing the literature, the panel convened to determine evidence levels and degrees of recommendations for intrathecal therapy. This meeting served as the basis for consensus development, which was ranked as strong, moderate or weak. Algorithms were developed for intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain. RESULTS: The PACC has developed an algorithmic process for several aspects of intrathecal drug delivery to promote safe and efficacious evidence-based care. Consensus opinion, based on expertise, was used to fill gaps in evidence. Thirty-one consensus points emerged from the panel considerations. CONCLUSION: New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

The Proper Use of Neurostimulation for Hand Pain.

Upper extremity neuropathic pain states greatly impact patient functionality and quality of life, despite appropriate surgical intervention. This article focuses on the advanced therapies that may improve pain care, including advanced treatment strategies that are available. The article also surveys therapies on the immediate horizon, such as spinal cord stimulation, peripheral nerve stimulation, and dorsal root ganglion spinal cord stimulation. As these therapies evolve, so too will their placement within the pain care algorithm grounded by a foundation of evidence to improve patient safety and management of patients with difficult neuropathic pain.

The differential diagnosis of low back pain: a primer on the evolving paradigm.

OBJECTIVES: The issue of low back pain (LBP) is as common as it is perplexing. LBP is thought to be a chronic issue in approximately 10% of the U.S. population. This condition has wide-reaching social and economical reverberations. Despite the availability of modern diagnostic tools, the cause of the pain generator is often unidentifiable. The authors were asked to create an overview of the etiology of LBP for physicians who implant neurostimulation devices for the treatment of chronic pain patients. Some prevalence data, based on the current available literature, have been provided for the more common structural conditions causing LBP. However, a comprehensive review of prevalence of various conditions and their respective manifestations as LBP is beyond the scope of this article. MATERIALS AND METHODS: A review was performed of frequently cited articles with search terms for "low back pain" using PubMed, Medline, and Google Scholar. The authors also reviewed other literature from commonly utilized sources in the field of interventional pain medicine such as the journals of Neuromodulation, Pain Medicine, Spine, and Neurosurgery in the publication date range of 1975 to the present. Moreover, recent edition textbooks of other specialties such as obstetrics and gynecology, neurology, internal medicine, and surgery were referenced to develop a comprehensive list of the differential diagnoses. In order to capture the broad scope of information presented in this article, the criteria used to choose the references included published peer-reviewed articles that provided information on LBP as a symptom of a case report to common presentations of various conditions as described in a number of current, and commonly used, textbooks in their specialty. RESULTS: The article serves as a reference for commonly cited causes of LBP as well as less common conditions presenting with LBP as a possible symptom, which may occur as a solitary pain generator or in combination with other etiologies. The information is structured in such a fashion to allow a comprehensive overview for every reader, including the most experienced implanting physicians. The article is designed to kindle critical thinking regarding the massive scope involved in the assessment of a patient with a complaint of LBP. The results of the comprehensive research to produce this article clearly indicate the broad scope of this list of differential diagnoses. The reader should be aware that the lists are by no means all-inclusive. Perhaps additional efforts will be necessary to build on the available information in this article in the future. Furthermore, although some prevalence data for LBP, as it is related to structural spine, is readily available based on the excellent work of our colleagues and presented throughout this paper, for other disease processes, the prevalence data are scarce to nonexistent. This underscores the need for further research to better understand this elusive condition. The size and breadth of the topic at hand in this article would arguably deserve its own comprehensive textbook. The complexity and discussion points of each identified pain generator could be given a chapter or section to reflect complex learning deserved by each topic. With these limitations, the authors recommend the reader to evaluate this article in the context of a broader topic of LBP and neurostimulation. CONCLUSIONS: LBP is an extremely common condition associated, as a symptom, with various disease processes, regardless of their relationship with the lumbar spine or its innervation. This article underscores the broad nature of LBP as a symptom of many diagnoses. The primary conclusion reached by the authors is the most important recommendation by all mentors in medicine, which is to obtain a comprehensive history and perform a complete physical examination on each patient. Despite the fact that there is an emerging school of thought questioning the validity of the physical examination, this tool continues to be the current standard of care and used by a majority of clinicians around the world. The physician must analyze the information obtained from his/her history, physical examination, and diagnostic tools with the recognition of the broad nature of the differential diagnoses of LBP in order to be able to best treat the patient.

The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. METHODS: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. RESULTS: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. CONCLUSIONS: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.

Stimulation of the peripheral nervous system for the painful extremity.

Peripheral nerve stimulation and, recently, peripheral nerve field stimulation are excellent options for the control of extremity pain in instances where conventional methods have failed and surgical treatment is ruled inappropriate. New techniques, ultrasound guidance, smaller generators, and task-specific neuromodulatory hardware and leads result in increasingly safe, stable and efficacious treatment of pain in the extremities. Peripheral nerve stimulation has shown to be an increasingly viable option for many painful conditions with neuropathic and possibly nociceptive origins. This chapter focuses on the historical use of neuromodulation in the extremities, technical tasks associated with implant, selection of candidates, and potential pitfalls of and solutions for implanting devices around the peripheral nervous system for extremity pain.