Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies.

INTRODUCTION: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society. AREAS COVERED: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data. EXPERT OPINION: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.

Neuromodulation for the management of chronic pelvic pain syndromes: A systematic review.

BACKGROUND: Chronic pelvic pain is a burdensome condition that involves multiple medical sub-specialties and is often difficult to treat. Sacral stimulation for functional bladder disease has been well established, but little large-scale evidence exists regarding utilization of other neuromodulation techniques to treat chronic pelvic pain. Emerging evidence does suggest that neuromodulation is a promising treatment, and we aim to characterize the use and efficacy of such techniques for treating chronic pelvic pain syndromes. MATERIALS AND METHODS: A systematic review of the literature demonstrating the treatment of chronic pelvic pain syndromes with neuromodulation. Abstracts were reviewed and selected for inclusion, including case series, prospective studies, and randomized controlled trials (RCTs). Case studies and publications in abstract only were not included. The reporting for this systematic review follows Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The literature search was performed using MEDLINE, Embase, Cochrane Library, PubMed, CINAHL, and Scopus. RESULTS: A total of 50 studies were included in this review, three of which were randomized controlled trials, and the remaining were prospective and retrospective case series. The range of pelvic pain conditions treated included interstitial cystitis, peripheral neuralgia, pudendal neuralgia, gastrointestinal pain, urogenital pain, sacroiliac joint pain, and visceral chronic pelvic pain. We reported on outcomes involving pain, functionality, psychosocial improvement, and medication reduction. CONCLUSIONS: Neuromodulation is a growing treatment for various chronic pain syndromes. Peripheral nerve stimulation was the least studied form of stimulation. Posterior tibial nerve stimulation appears to offer short-term benefit, but long-term results are challenging. Sacral nerve stimulation is established for use in functional bladder syndromes and appears to offer pain improvement in these patients as well. Dorsal root ganglion stimulation and spinal cord stimulation have been used for a variety of conditions with promising results. Further studies of homogeneous patient populations are necessary before strong recommendations can be made at this time, although pooled analysis may also be impactful.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based upon 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 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.

Anesthetic Considerations and Perioperative Management of Spinal Cord Stimulators: Literature Review and Initial Recommendations.

BACKGROUND: Patients with implanted spinal cord stimulators (SCS) present to the anesthesia care team for management at many different points along the care continuum. Currently, the literature is sparse on the perioperative management. What is available is confusing; monopolar electrocautery is contraindicated but often used, full body magnetic resonance imaging (MRI) is safe with particular systems but with other manufactures only head and specific extremities exams are safe. Moreover, there are anesthetizing locations outside of the operating room where implanted SCS can interact with surrounding medical equipment and pose significant risk to patient and device. OBJECTIVES: The objective of this review is to present relevant known literature about the safe management of SCS in the perioperative period and to begin to develop recommendations. STUDY DESIGN: A review of current literature and each manufacturers' labeling was performed to assess risk of interference and patient harm between SCS and technology used in and around typical anesthetizing locations. METHODS: A systematic search of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. A computerized search was conducted for English articles in print up to April 2016 via PubMed www.ncbi.nlm.nih.gov/pubmed; EMBASE www.embase.com; and Cochrane Library www.thecochranelibrary.com. Search terms included "spinal cord stimulator AND MRI," "spinal cord stimulator AND ECG," "spinal cord stimulator AND implanted cardiac device," "spinal cord stimulator AND electrocautery," and "spinal cord stimulator AND obstetrics." In addition, a search of Google and Google Scholar was performed. Websites of SCS manufactures were reviewed. RESULTS: Generalized recommendations include turning the amplitude of the SCS to the lowest possible SETTING and turning off prior to any procedure. Monopolar electrocautery is contraindicated but is still often utilized; placing grounding pads as far away from the device can reduce the risk to device and patient. Bipolar cautery is favored. Implanted cardiac devices can interfere with SCS, but risks can be minimized. Neuraxial anesthesia can be attempted in a patient with implanted SCS, provided the device is not in the expected path. MRI labeling differences present the biggest difference among SCS manufactures. Medtronic's SureScan SCS, Boston Scientific's Precision system, St. Jude's Proclaim, and Stimwave's Freedome SCS are full body MRI compatible under specific conditions, while other manufacturers have labeling that restricts exams of the trunk and certain extremities. LIMITATIONS: This review was intended to be a comprehensive, cumulative review of recommendations for perioperative SCS management; however, the limitations of a review of this nature is the complete reliance on previously published research and the availability of these studies using the methods outlined. CONCLUSIONS: SCS is being used earlier in the treatment algorithm for patients with chronic pain. The anesthesia care team needs working knowledge of where the device resides in the neuraxial space and what risks different medical technologies pose to the patient and device. This understanding will lead to appropriate perioperative management which can reduce risk and improve patient outcomes.