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Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, there are few studies of longevity of SCS in the real world.This was an observational, nonrandomized, retrospective study of Medicare beneficiaries who received neurostimulator implants in the outpatient hospital. This study used Medicare fee-for-service claims data from 2013 to 2020. The clinical longevity of the implantable pulse generator (IPG), defined as the duration from implant until removal for any reason, was compared between PC and RC devices. Life distribution analysis was used to approximate device lifespan. The secondary analysis separated removals into explant or replacements. The statistics were adjusted for relevant clinical covariates.A total of 25,856 PC and 79,606 RC systems were included in the study. At seven years after implant, 53.8% of PC IPGs and 55.0% of RC IPGs remained in use. The life distribution modeling analysis projected a median lifespan of 8.2 years for PC and 9.0 years for RC devices. The rate of explant was lower for PC devices (19.2%) than for RC devices (22.0%, hazard ratio (HR) = 0.96, p = 0.082), whereas the rate of replacements was higher for PC devices (33.7%) than for RC devices (29.5%, HR = 1.31, p 0.001). An analysis of the battery type used in device replacements showed an increasing adoption of PC devices over time.This large, retrospective, real-world analysis of Medicare claims data demonstrated that the clinical longevity of neurostimulator devices is similar for PC and RC batteries. In the past, clinicians may have defaulted to RC devices based on the assumption that they provided extended battery life. Considering this longevity data, clinicians should now consider the choice between PC and RC devices based on other individual factors pertinent to the patient experience and not on purported longevity claims.

Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist.After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator's discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey.Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications.This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes.The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice.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 LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented.The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety.ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.

Chronic pain is debilitating and profoundly affects health-related quality of life. Spinal cord stimulation (SCS) is a well-established therapy for chronic pain; however, SCS has been limited by the inability to directly measure the elicited neural response, precluding confirmation of neural activation and continuous therapy. A novel SCS system measures the evoked compound action potentials (ECAPs) to produce a real-time physiological closed-loop control system.To determine whether ECAP-controlled, closed-loop SCS is associated with better outcomes compared with fixed-output, open-loop SCS at 24 months following implant.The Evoke study was a double-blind, randomized, controlled, parallel arm clinical trial with 36 months of follow-up. Participants were enrolled from February 2017 to 2018, and the study was conducted at 13 US investigation sites. SCS candidates with chronic, intractable back and leg pain refractory to conservative therapy, who consented, were screened. Key eligibility criteria included overall, back, and leg pain visual analog scale score of 60 mm or more; Oswestry Disability Index score of 41 to 80; stable pain medications; and no previous SCS. Analysis took place from October 2020 to April 2021.ECAP-controlled, closed-loop SCS was compared with fixed-output, open-loop SCS.Reported here are the 24-month outcomes of the trial, which include all randomized patients in the primary and safety analyses. The primary outcome was a reduction of 50% or more in overall back and leg pain assessed at 3 and 12 months (previously published).Of 134 randomized patients, 65 (48.5%) were female and the mean (SD) age was 55.2 (10.6) years. At 24 months, significantly more closed-loop than open-loop patients were responders (≥50% reduction) in overall pain (53 of 67 [79.1%] in the closed-loop group; 36 of 67 [53.7%] in the open-loop group; difference, 25.4% [95% CI, 10.0%-40.8%]; P = .001). There was no difference in safety profiles between groups (difference in rate of study-related adverse events: 6.0 [95% CI, -7.8 to 19.7]). Improvements were also observed in health-related quality of life, physical and emotional functioning, and sleep, in parallel with opioid reduction or elimination. Objective neurophysiological measurements substantiated the clinical outcomes and provided evidence of activation of inhibitory pain mechanisms.ECAP-controlled, closed-loop SCS, which elicited a more consistent neural response, was associated with sustained superior pain relief at 24 months, consistent with the 3- and 12-month outcomes.

Background Multidimensional patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The PROMIS-29 assessment tool is utilized as a component of assessing multidimensional pain scales. It includes patient-reported measures of pain, mood, sleep, social participation, and function. Currently, there are no data on whether a patient’s immediate environment (remote versus in person) influences the reported patient outcomes measurement of a multidimensional tool represented as PROMIS-29 data. Methods Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into a chronic pain or spine center in the United States. The PROMIS-29 v2.1 was recorded. Statistical differences were assessed among age groups and across the seven domains of the assessment. Results A total of 25,187 distinct patients were enrolled in the study from August 2018 to December 2020 with a presenting baseline measurement of PROMIS-29. The PROMIS-29 v2.1 was evaluated across the seven domains, and subgroup age analysis was performed for patients completing surveys in the clinical setting (non-remote group) and those completing the survey in the remote setting (remote group) during entry into spine and pain practices across the United States. For mental health scores, those less than 40 years of age and those over 80 years of age showed significant differences in ratings of anxiety and depression in the remote versus non-remote setting. Regarding physical health scores, those aged 60–79 showed a significant difference in the remote versus non-remote ratings for pain interference (p = 0.005; 63.9 vs. 64.4), physical function (p = 0.000; 36.4 vs. 35.7), and fatigue (p = 0.020; 57.2 vs. 57.7), while subjects over 80 years of age showed a statistical difference between the remote versus non-remote setting only in rating physical function (p = 0.025; 33.0 vs. 34). Notably, the rating of sleep disturbance in the remote versus non-remote setting was the only significant variable in the 40–59 age category (p = 0.000; 60.0 vs. 59.1). Those less than 40 years of age also reported a significant difference in the remote versus non-remote setting when rating sleep disturbance (p = 0.000; 60.5 vs. 58.9). With regard to social function, only those older than 80 years showed a significant difference in rating of ability in the remote compared to the non-remote setting (p = 0.031; 39.6 vs. 40.7). Conclusions This data set is the first published data describing the influence of environment (remote versus in person) on PROMIS-29 outcome measurements in the chronic pain population.

Jason E Pope,1 Michael A Fishman,2 Joshua A Gunn,3 Bradley M Cotten,3 Melissa M Hill,3 Timothy R Deer4 1Evolve Restorative Center, Santa Rosa, CA, USA; 2Center for Interventional Pain and Spine, Lancaster, PA, USA; 3Ethos Research and Development, LLC, Newport, KY, USA; 4The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Jason E PopeEvolve Restorative Center, Santa Rosa, CA, USATel +1844 527-7369Email jepope@evolverestorativecenter.carePurpose: Discovery and validation of pragmatic biomarkers represent significant advancements in the field of pain management. Evaluating relationships between objective biomarkers and patient-reported outcomes (PROs) is an effective way to gain mechanistic insight into the potential role of biochemistry in chronic pain. The aim of this study was to validate the Foundation Pain Index (FPI) by evaluating associations between deranged biochemical function and PROMIS-29 domains in individuals living with chronic pain.Patients and Methods: PROMIS-29 scores and FPI test results were obtained from 298 patients with chronic pain in this retrospective, observational study. Statistical analysis was performed using clinical test data to evaluate relationships between deranged biochemical function and quality of life measures across 8 universal domains.Results: FPI scores significantly associated with multiple PROMIS-29 domains including physical function, impact score, fatigue, pain interference, and depression (P < 0.05). Moreover, specific analytes that comprise the FPI significantly correlated with PROMIS-29 domains, including 5-hydroxyindolacetic acid (pain interference, physical function, and pain impact scores), hydroxymethylglutarate (physical function), homocysteine (pain impact scores), kynurenic acid (pain interference and physical function), and quinolinic acid (physical function) (P < 0.05).Conclusion: Cross-validation of the FPI with PROMIS-29 domains further supports the role of deranged biochemical function in the etiology of chronic pain. Objective identification of atypical biochemical function and subsequent correction holds tremendous promise for the non-opioid management of pain. Continued research efforts will aim to determine the impact of biochemical optimization in pre-surgical periods and post-surgical outcomes in patients with chronic pain.Keywords: biomarker, pain, oxidative stress, neurotransmitter, micronutrient deficiency, kynurenine pathway

BACKGROUND: Treatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects on pain intensity. However, chronic pain is a multidimensional condition that may affect individuals in different ways and as such it seems reductionist to evaluate treatment response based solely on a unidimensional measure such as pain intensity. AIM: The aim of this article is to add to a framework started by IMMPACT for assessing the wider health impact of treatment with SCS for people with chronic pain, a "holistic treatment response". DISCUSSION: Several aspects need consideration in the assessment of a holistic treatment response. SCS device data and how it relates to patient outcomes, is essential to improve the understanding of the different types of SCS, improve patient selection, long-term clinical outcomes, and reproducibility of findings. The outcomes to include in the evaluation of a holistic treatment response need to consider clinical relevance for patients and clinicians. Assessment of theholistic response combines two key concepts of patient assessment: (1) patients level of baseline (pre-treatment) unmet need across a range of health domains; (2) demonstration of patient-relevant improvements in these health domains with treatment. The minimal clinical important difference (MCID) is an established approach to reflect changes after a clinical intervention that are meaningful for the patient and can be used to identify treatment response to each individual domain. A holistic treatment response needs to account for MCIDs in all domains of importance for which the patient presents dysfunctional scores pre-treatment. The number of domains included in a holistic treatment response may vary and should be considered on an individual basis. Physiologic confirmation of therapy delivery and utilisation should be included as part of the evaluation of a holistic treatment response and is essential to advance the field of SCS and increase transparency and reproducibility of the findings.

Steven M Falowski,1 Vipul Mangal,2 Jason Pope,3 Anish Patel,4 Mark Coleman,5 Dan Kendall,6 Richard Brouillette,7 Michael A Fishman8 1Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 2National Spine and Pain, National Harbor, MD, USA; 3Evolve Restoration, Santa Rosa, CA, USA; 4National Spine and Pain, Frederick, MD, USA; 5National Spine and Pain, Pikesville, MD, USA; 6National Spine and Pain, McLean, VA, USA; 7National Spine and Pain, White Plains, MD, USA; 8Center for Interventional Pain and Spine, Lancaster, PA, USACorrespondence: Steven M FalowskiDirector Functional Neurosurgery, Neurosurgical Associates of Lancaster, 160 N Pointe Blvd Suite 200, Lancaster, PA, 17601, USATel +1 717-358-0800Email sfalowski@gmail.comIntroduction: Several treatment options exist for those with spinal stenosis, as well as degenerative changes. This series evaluates the use of an interspinous fixation (ISF) device as performed by interventional pain physicians.Methods: This is a retrospective analysis identifying 32 patients with the diagnosis of lumbar degenerative disc disease with secondary diagnosis of lumbar spinal stenosis being treated with ISF with Aurora Spine Zip Interspinous Spacer. Serious adverse events, specifically nerve injury, hematoma, infection, and death, were analyzed quantitatively for reported complications within 90 days from the procedure. In addition, VAS was analyzed for patient reported outcomes.Results: Adverse event rate was 0% with no incidences of reoperation, or device removal. Estimated blood loss was recorded as less than 50 cc for all patients. The preoperative pain assessment demonstrated an average pain score of 8.1 and a postoperative pain score of 2.65 equating to a percentage pain reduction of 67%.Conclusion: This case series demonstrates the success and safety of ISF being performed by interventional pain physicians in an outpatient setting. It is a valuable tool in the treatment of moderate to severe lumbar spinal stenosis and degenerative disc disease that has decreased morbidity and significant efficacy.Keywords: interspinous spacer, indirect decompression, interspinous fusion, interspinous fixation, lumbar degenerative disc disease, spinal stenosis, lumbar stenosis, spinal fusion

Multidisciplinary patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The use of multidisciplinary patient-reported outcomes is recommended in many areas of medicine. The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has been utilized as a common measurement language across universally relevant domains, including pain, mood, sleep, social participation, and function. Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into chronic pain centers across 24 sites in the United States. The PROMIS-29 v2.1 and the numerical rating scale (NRS) were recorded. The pain impact score and the Health Utilities Index Mark 3 (HUI-3) were calculated. Statistical differences were assessed between genders and among age groups comprising subjects less than 40, 41–60, 61–80, and over 80 years of age. A total of 19,546 patients were assessed over the enrollment period from 2018 to 2020. The PROMIS-29 v2.1 was evaluated across the seven domains, along with the numerical rating sale (NRS). The mean scores of the population for PROMIS SF v1.0 Pain Interference 4a, PROMIS SF v1.0 Sleep Disturbance 4a, PROMIS SF v1.0 Fatigue 4a, PROMIS SF v1.0 Anxiety 4a, PROMIS SF V1.0 Depression 4a, PROMIS SF v2.0 Ability to Participate in Social Roles and Activities 4a, and PROMIS SF v1.0 Physical Function 4a, measuring pain interference, sleep disturbance, fatigue, anxiety, depression, social participation, and physical function, were 64.61, 57.19, 58.50, 53.94, 54.45, 40.06, and 36.23, respectively. Pain intensity was 6.38 on an 11-point NRS scale. The pain impact score (PIS) and health utilities index mark 3 (HUI-3) scores, calculated across the designated age groups, were 33.19 and 0.67, respectively. Statistical differences were observed for the domains of sleep disturbance and physical function for age groups less than 40 and greater than 80 years of age. This data set is the first published normative data set describing the PROMIS-29 assessment in the chronic pain population. The patient population is more homogeneous than expected, and females were found to have higher levels of dysfunction.

Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is to investigate prospectively the safety and efficacy of this approach.A multicenter, prospective, single arm study was performed after patient identification and treatment with the novel posterior fusion, single-point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months is presented. Primary endpoint at 6-month analysis was Pain Intensity reduction by visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis.In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were three adverse events, all unrelated to the device.The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.

Introduction The sacroiliac joint (SIJ) has been estimated to contribute to pain in as much as 38% of cases of lower back pain. There are no clear diagnostic or treatment pathways. This article seeks to establish a clearer pathway and algorithm for treating patients.

Introduction Despite Accredited Counsel of Graduate Medical Education (ACGME) guidance and criteria, there remains variability in training both within each specialty and across the specialties involved in the delivery of neuromodulation. NANS advocates for the efficacious and safe the implementation of neuromodulation and therefore an educational mentoring program with a defined educational platform is needed. Materials and methods This is a structured, patient centered, and evidence-based approach mentorship program performed more than one year. Mentor/Mentee pairs started in 2015 and data collected were more than a five-year period. Results There was a 70%-86% response rate on each survey administered. All except one respondent reported that the mentorship program met their previously declared expectations. All the respondents self-reported at least a moderate increase in their knowledge in the field of neuromodulation while 54% of the respondents felt their knowledge in the field to have greatly increased. Most respondents reported an increase in the number of spinal cord stimulator trials and permanent implants performed after the mentorship program. The self-reporting of mentees competencies at the conclusion of the program was statistically significant for higher competency scores in all areas assessed. Conclusions The NANs mentorship program met expectations and implementation goals by improving neuromodulation education including covering patient care, delivery, and training topics. The mentoring program provides a structured framework for extending formal physician neuromodulation education outside of direct fellowship training.

Objectives The evolution of neuromodulation devices in order to enter magnetic resonance imaging (MRI) scanners has been one of understanding limitations, engineering modifications, and the development of a consensus within the community in which the FDA could safely administer labeling for the devices. In the initial decades of neuromodulation, it has been contraindicated for MRI use with implanted devices. In this review, we take a comprehensive approach to address all the major products currently on the market in order to provide physicians with the ability to determine when an MRI can be performed for each type of device implant. Materials and methods We have prepared a narrative review of MRI guidelines for currently marketed implanted neuromodulation devices including spinal cord stimulators, intrathecal drug delivery systems, peripheral nerve stimulators, deep brain stimulators, vagal nerve stimulators, and sacral nerve stimulators. Data sources included relevant literature identified through searches of PubMed, MEDLINE/OVID, SCOPUS, and manual searches of the bibliographies of known primary and review articles, as well as manufacturer-provided information. Results Guidelines and recommendations for each device and their respective guidelines for use in and around MR environments are presented. Conclusions This is the first comprehensive guideline with regards to various devices in the market and MRI compatibility from the American Society of Pain and Neuroscience.

ObjectiveTo conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain.DesignGrade the evidence for DRG stimulation.MethodsAn international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques–Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria.ResultsDRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies.ConclusionsModerate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.

Introduction Chronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to painful symptoms. Methods We describe the clinical validation of a multi-biomarker assay with algorithmic analysis known as the Foundation Pain Index (FPI) in diverse cohorts of chronic pain patients in a prospective, cross-sectional, observational validation study. Levels of 11 urinary pain biomarkers were measured and tabulated using a proprietary algorithm to generate FPI scores for chronic pain subjects (N = 153) and age- and sex-matched pain-free controls (N = 334). Results FPI scores were significantly correlated with the 36-Item Short Form Health Survey (SF-36) scores among chronic pain subjects (P value

Background The current coronavirus disease 2019 (COVID-19) pandemic led to a significant disruption in the care of pain from chronic and subacute conditions. The impact of this cessation of pain treatment may have unintended consequences of increased pain, reduced function, increased reliance on opioid medications, and potential increased morbidity, due to the systemic impact of untreated disease burden. This may include decreased mobility, reduction in overall health status, and increase of opioid use with the associated risks. Methods The article is the study of the American Society of Pain and Neuroscience (ASPN) COVID-19 task force to evaluate the policies set forth by federal, state, and local agencies to reduce or eliminate elective procedures for those patients with pain from spine, nerve, and joint disease. The impact of these decisions, which were needed to reduce the spread of the pandemic, led to a delay in care for many patients. We hence review an emergence plan to reinitiate this pain-related care. The goal is to outline a path to work with federal, state, and local authorities to combat the spread of the pandemic and minimize the deleterious impact of pain and suffering on our chronic pain patients. Results The article sets forth a strategy for the interventional pain centers to reemerge from the current pandemic and to set a course for future events. Conclusions The COVID-19 pandemic represents an overwhelming challenge to interventional pain physicians and their patients. In addition to urgent actions needed for disease mitigation, the ASPN recommends a staged return to pain management professionals' workflow.

The ACCURATE randomized, controlled trial compared outcomes of dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS) in 152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II. This ACCURATE substudy was designed to evaluate whether therapy habituation occurs with DRG stimulation as compared to SCS through 12-months. A modified intention-to-treat analysis was performed to assess percentage pain relief (PPR) and responder rates at follow-up visits (end-of-trial, 1, 3, 6, 9, 12-months postpermanent implant) for all subjects that completed trial stimulation (DRG:N = 73, SCS:N = 72). For both groups, mean PPR was significantly greater at end-of-trial (DRG = 82.2%, SCS =0 77.0%) than all other follow-ups. Following permanent DRG system implantation, none of the time points were significantly different from one another in PPR (range = 69.3–73.9%). For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%). The responder rate also decreased for the SCS group from 1-month (68.1%) to 12-months (61.1%). After stratifying by diagnosis, it was found that only the CRPS-I population had diminishing pain relief with SCS. DRG stimulation resulted in more stable pain relief through 12-months, while tonic SCS demonstrated therapy habituation at 9- and 12-months. Trial Registration: The ACCURATE study was registered at ClinicalTrials.gov with Identifier NCT01923285. Perspective This article reports on an ACCURATE substudy, which found that long-term therapy habituation occurred at 12-months with SCS, but not DRG stimulation, in patients with CRPS. The underlying mechanisms of action for these results remain unclear, although several lines of inquiry are proposed.

INTRODUCTION Intermittent dosing (ID), in which periods of stimulation-on are alternated with periods of stimulation-off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation-off periods in patients with chronic intractable pain. MATERIALS AND METHODS This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation-off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant. RESULTS Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p

Summary Background Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain. Methods This multicentre, double-blind, parallel-arm, randomised controlled trial was done at 13 specialist clinics, academic centres, and hospitals in the USA. Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm; Oswestry Disability Index [ODI] score 41–80) who were refractory to conservative therapy, on stable pain medications, had no previous experience with spinal cord stimulation, and were appropriate candidates for a spinal cord stimulation trial were screened. Eligible patients were randomly assigned (1:1) to receive ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group). The randomisation sequence was computer generated with permuted blocks of size 4 and 6 and stratified by site. Patients, investigators, and site staff were masked to the treatment assignment. The primary outcome was the proportion of patients with a reduction of 50% or more in overall back and leg pain with no increase in pain medications. Non-inferiority (δ=10%) followed by superiority were tested in the intention-to-treat population at 3 months (primary analysis) and 12 months (additional prespecified analysis) after the permanent implant. This study is registered with ClinicalTrials.gov , NCT02924129 , and is ongoing. Findings Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned (67 to each treatment group). The intention-to-treat analysis comprised 125 patients at 3 months (62 in the closed-loop group and 63 in the open-loop group) and 118 patients at 12 months (59 in the closed-loop group and 59 in the open-loop group). The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6–37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3–37·7; p=0·0060). We observed no differences in safety profiles between the two groups. The most frequently reported study-related adverse events in both groups were lead migration (nine [7%] patients), implantable pulse generator pocket pain (five [4%]), and muscle spasm or cramp (three [2%]). Interpretation ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop spinal cord stimulation. Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation. Funding Saluda Medical.

Introduction ACCURATE, a randomized controlled trial comparing dorsal root ganglion (DRG) stimulation to spinal cord stimulation, showed that DRG stimulation is a safe and effective therapy in individuals with lower extremity chronic pain due to complex regional pain syndrome (CRPS) type I or II. Investigators noted that DRG stimulation programming could be adjusted to minimize, or eliminate, the feeling of paresthesia while maintaining adequate pain relief. The present study explores treatment outcomes for DRG subjects who were paresthesia-free vs. those who experienced the sensation of paresthesia, as well as the factors that predicted paresthesia-free analgesia. Methods A retrospective analysis of therapy outcomes was conducted for 61 subjects in the ACCURATE study who received a permanent DRG neurostimulator. Outcomes of subjects who were paresthesia-free were compared to those who experienced paresthesia-present therapy at 1, 3, 6, 9, and 12-month follow-ups. Predictor variables for the presence or absence of paresthesias with DRG stimulation were also explored. Results The percentage of subjects with paresthesia-free pain relief increased from 16.4% at 1-month to 38.3% at 12-months. Paresthesia-free subjects generally had similar or better outcomes for pain severity, pain interference, quality of life, and mood state as subjects with paresthesia-present stimulation. Factors that increased the odds of a subject feeling paresthesia were higher stimulation amplitudes and frequencies, number of implanted leads, and younger age. Conclusions Some DRG subjects achieved effective paresthesia-free analgesia in the ACCURATE trial. This supports the observation that paresthesia is not synonymous with pain relief or required for optimal analgesia with DRG stimulation.

Radiofrequency ablation (RFA) has been utilized since the 1970s to treat various painful conditions. The technology has evolved from its initial use to treat lumbar facet mediated pain with monopolar lesioning to now treat a plethora of chronic pain conditions. This article reviews Abbott Corporation's (IL, USA) IonicRF™ generator. The IonicRF generator utilizes an intelligent power algorithm that improves efficiency and reduces procedure time. The generator also carries a wide range of RFA therapies such as monopolar, bipolar, pulsed or pulsed dose radiofrequency. Additionally, the IonicRF RFA generator is compatible with the Simplicity™ RF probe (Abbott) which allows for efficient and effective denervation of the sacroiliac joint.Lay abstract Radiofrequency ablation (RFA) has been utilized since the 1970s to treat many different painful conditions. The technique was originally developed to treat common low back pain because of arthritis. Since that time, RFA has evolved to treat other painful areas of the body such as the face, knees, shoulders, hips and buttocks. RFA is a safe, convenient, and non-surgical option to treat pain in these different areas of the body. This technique is reserved for patients who have already tried physical therapy and over the counter pain medications such as ibuprofen and acetaminophen.

Introduction: The choice of the proper intrathecal drug to treat neuropathic pain has been subject to much debate in recent years. Areas Covered: Currently, the United States Food and Drug Administration (USFDA) has approved two drugs for chronic intrathecal use for the treatment of pain; however, there has been substantial growth in the development of other intrathecal drugs that can be used for neuropathic pain. We performed a PubMed literature search looking at intrathecal drug research for neuropathic pain between January 2005 to May 2019 and discuss current practices and mechanisms in treating these complex patients. Expert Opinion: On-label intrathecal drugs are recommended if efficacious with acceptable side effects. In those suffering from neuropathic pain, clinical evidence suggests additional drug algorithms for treating these patients are necessary. There is ample room for growth in the development and approval of novel drugs for intrathecal delivery to manage neuropathic pain.

Background Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies, including a large prospective, randomized, controlled trial. Both safety and efficacy have been demonstrated utilizing this therapeutic approach for many chronic complaints. Continued assessment of neuromodulation therapies, such as DRG stimulation, are not only an important aspect of vigilant care, but are also necessary for the evaluation for safety. Materials and methods Safety and complaint records for DRG and spinal cord stimulation (SCS) stimulation were obtained from the manufacturer, analyzed and compiled to further assess ongoing device safety. Complaint event data were stratified according to complain type as well as overall rates. Data from similar time periods were compared between epidural neurostimulation devices by the same manufacturer as well as rates reported in the literature. Results Overall, DRG stimulation device event rates were lower or comparable to similar epidurally placed neurostimulation devices. Rates of events varied from 0 to 1.0% for DRG stimulation (n >500+ implants) which was similar to the event rate for SCS by the same manufacturer (n >2000+ implants). In comparison, complaints and adverse events ranged from 0 to 14% for SCS in the literature. Discussions The current results from a large consecutive cohort obtained from manufacturer records indicates that DRG stimulation demonstrates an excellent safety profile. Reported event rates are similar to previously reported adverse event and complaint rates in the literature for this therapy. Similarly, safety events rates were lower or similar to previously reported rates for SCS, further demonstrating the comparative safety of this neuromodulation technique for chronic pain treatment.

Spinal cord stimulation has emerged as a state-of-the-art evidence-based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation. In a previous review, the authors commented on the 5-year forecast for high frequency and Burst waveforms, as the only two paresthesia independent SCS strategies. Over the last 5 years, there has been considerable addition to the outcome data related to these modalities. Additionally, new treatment algorithms and modalities for spinal cord stimulation have emerged. In this review, the authors provide an up to date summary of these modalities of treatment, indications, and evidence on all different modalities and programming paradigms that are available today.A literature review was performed using key bibliographic databases to find outcomes related studies pertaining to spinal cord stimulation, limited to the English language and human data, between 2010 and 2018. The literature search yielded the following based on our inclusion criteria; six articles on burst stimulation, three articled on high density/high dose stimulation, six articles on Dorsal Root Ganglion stimulation, nine articles on high-frequency stimulation, and one article on closed-loop stimulation. We have also included in the discussion some smaller and anecdotal studies.The evidence to support outcomes of spinal cord stimulation has evolved considerably since our last review in 2014. New targets, frequencies and pulse trains, and feedback appear to have advanced the efficacy of spinal cord stimulation. Future developments aim to continue to refine patient selection and maintenance of patients in therapy.

Introduction Dorsal root ganglion stimulation (DRGS) is a powerful tool in the treatment of chronic, neuropathic pain. The premise of DRGS is similar to that of conventional spinal cord stimulation (cSCS), however, there is more variability in how it can be utilized. While it is this variability that likely gives it its versatility, DRGS is not as straightforward to implement as cSCS. The purpose of this study was to assess the efficacy of DRGS on a broad number of diagnoses, determine which dorsal root ganglia were associated with better outcomes for particular body parts/diagnoses, and evaluate what factors/parameters were associated with higher rates of trial success. Methods This is a physician initiated, multicenter retrospective registry of 217 patients trialed with DRGS. Data were collected via an online questionnaire that assessed specifics regarding the patient's pain, distribution, size, and response to treatment. The data were analyzed to see if there were certain diagnoses and/or parameters that were more or less associated with trial success. Results DRGS was found to be an effective treatment in all diagnoses evaluated within this study, most of which had statistically significant improvements in pain. The most important predictor of trial success was the amount of painful area covered by paresthesias during the programing phase. The number of leads utilized had a direct and indirect impact on trial success. Pain in the distribution of a specific peripheral nerve responded best and there was no statistical difference based on what body part was being treated. Conclusion DRGS can be an effective treatment for a variety of neuropathic pain syndromes, in addition to CRPS. It is recommended that a minimum of 2 leads should be utilized per area being treated. In addition, this therapy was shown to be equally efficacious in any body part/region so long as the area being treated is focal and not widespread.

Background Peripheral neuropathy is a chronic pain disorder involving physical, chemical, or metabolic damage to peripheral nerves. Its pain can be intense and disabling. Dorsal root ganglion (DRG) stimulation is an effective treatment for neuropathic pain, including cases with the limited regional distributions that often characterize peripheral neuropathy. Methods A retrospective analysis was completed. Patients were included on the basis of having chronic intractable peripheral neuropathy of the legs and/or feet and responding successfully to a trial of DRG stimulation with leads at L4-S1. Visual analog scale pain scores and pain medication usage were collected at the baseline visit and after six weeks of treatment. Eight consecutive patients across two study centers were included (7 male, 1 female; mean age: 64.8 ± 10.2 years). Six cases of neuropathy were bilateral and two were unilateral. One patient presented with chronic radiculopathy, two patients had neuropathy associated with diabetes, and five patients had neuropathy not associated with a diabetes history. Results The pain was rated 7.38 ± 0.74 at baseline and decreased to 1.50 ± 1.31 at the 6-week follow-up, a reduction of 79.5 ± 18.8%. For individual patients, pain relief ranged from 42.86% to 100.00%; two patients experienced complete elimination of pain while seven of the eight patients experienced greater than 50% pain relief. In addition, three patients significantly decreased their pain medication use and four were able to discontinue their medications entirely. Conclusion This small multicenter retrospective case series provides preliminary evidence that the painful symptoms of general peripheral neuropathy in the lower extremities, as well as associated pain medication usage, can be effectively managed by DRG stimulation at the L4-S1 spinal level. Importantly, this treatment appears efficacious for peripheral neuropathy.

Jason E Pope,1 Timothy R Deer,2 Steven M Falowski3 1Evolve Restorative Center, Santa Rosa, CA, USA; 2The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 3Neurosurgical Associates of Lancaster, Lancaster, PA, USACorrespondence: Jason E Pope Email popeje@me.comIntroduction: Low-back pain with accompanying neurogenic claudication is a common diagnosis in pain and spine centers around the world, with an evolving algorithm of treatment. One option for the treatment of neurogenic claudication by decompressive strategies centers on percutaneous direct decompressive techniques. Although commonly employed in clinical practice, there have been no formal investigations looking at safety of percutaneous direct decompression without the use of an epidurogram and relying on osteal landmarks. The purpose of this study was to investigate the safety of percutaneous direct decompression performed without the use of the epidurogram.Methods: After an IRB exemption had been obtained from the Western Investigational Review Board, data were retrospectively analyzed from July 2018 to August 2020 on patients that had undergone percutaneous direct decompression using the Mild procedure in a single center by a single physician. Data were analyzed quantitatively for reported complications within 3 months of the procedure, including nerve injury, hematoma, infection, death, or allergic reaction to contrast use.&#x2013Results: Chart review yielded 147 individual patients who had undergone percutaneous direct decompression from July 2018 to August 2020. In this data set, women outnumbered men, with an average age of 76 years, with L4–L5 followed by L3–L4 being the most common levels decompressed. Of the 147 patients was performed, utilizing an epidurogram versus no epidurogram for decompression, with no complications. These data are the first to describe the safety of percutaneous direct lumbar decompression without the use of contrast.Conclusion: This study strongly suggests the use of an epidurogram is not necessary for the safe decompression of a patient with symptomatic spinal stenosis and neurogenic claudication utilizing percutaneous direct decompression.Keywords: spinal stenosis, lumbar stenosis, minimally invasive, epidurogram

Background Spinal cord stimulation is a well-established modality for the treatment of chronic intractable pain. The safety and efficacy of various stimulation therapy designs have been demonstrated in multiple randomized controlled studies, oftentimes comparing an investigational device to an existing commercial therapy. In the real-world setting, data are lacking regarding selection of spinal cord stimulation (SCS) therapy, as waveform, pulse trains, and programming are not interchangeable among the devices. The purpose of this study is to help dissect a methodology for a patient centric multisystem trialing. Methods We conducted a single center, retrospective, open label observational chart review. Between June 2017 and June 2019, 83 patients underwent SCS trials. Devices from four commercially available systems were trialed. Patients were given the opportunity to trial up to three systems. If the patient reported 50% or more pain relief/functional improvement with the trial, they were able to choose which system they liked best and proceed with implantation. Results There were 82% (68/83) of patients who proceeded to permanent implant, with 72 patients electing to trial more than one stimulation paradigm. Of those, 62 trialed 2 SCS systems, whereas 11 trialed 3. During the SCS trials, loss of efficacy due to lead migration was 1.2% (1/83) and no infections occurred. The average pain score measured on the numeric pain rating scale (NRS), improved from 6.8 at baseline to 2.9 after implantation. Conclusions Multisystem trialing is safe and effective in providing patients increased exposure to multiple commercially available SCS systems.

Michael A Fishman,1 Ajay B Antony,2 Corey W Hunter,3 Jason E Pope,4 Peter S Staats,5 Rahul Agarwal,6 Allison T Connolly,6 Nirav Dalal,6 Timothy R Deer7 1Center for Interventional Pain and Spine, Exton, PA, USA; 2The Orthopaedic Institute, Gainesville, FL, USA; 3Ainsworth Institute of Pain Management, New York, NY, USA; 4Evolve Restorative Center, Santa Rosa, CA, USA; 5Premier Pain Centers, Shrewsbury, NJ, USA; 6Abbott, Sylmar, CA, USA; 7The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Michael A FishmanCenter for Interventional Pain and Spine, 160 North Pointe Blvd Suite 208, Lancaster, PA, 17603, USATel +1 917-543-6588Email mafishman@gmail.comBackground and Aims: Chronic pain affects more adults in the United States than any other condition. Opioid medications are widely used in the treatment of chronic pain, but there remains considerable risk and cost associated with their use. This study aims to characterize the effects of opioid prescribing for chronic pain and similar pain conditions on lost productivity in the United States.Methods: This was a retrospective, longitudinal, observational study of chronic pain patients in 2011– 2014. We identified patients with a diagnosis of musculoskeletal pain receiving index prescription for opioids in administrative claims and studied disability absence in a linked health and productivity management database. Patients were grouped as de novo and continued use opioid users before index, and by opioid dose in the year after index. Days of disability were compared before and after index with bootstrapping. Effect of opioid dose group on disability was evaluated with negative binomial regression. Lost productivity cost was compared before and after index.Results: The cohort contained 16,273 de novo and 6604 continued use patients. On average, de novo patients used 24.8 days of disability after index, an increase of 18.3 more days compared to before (p < 0.001). Continued use patients used 30.7 days after index, 9 more days than before (p < 0.001). There was a dose–response relationship between dose group and days of disability in de novo patients (p < 0.001). The weighted-average cost per person of lost productivity was $4344 higher in the year after index compared to the year before.Conclusion: Opioid prescriptions for pain patients were associated with significant disability use and lost productivity costs. With the evolution of opioid-prescribing practices, CDC recommendations, and the HHS Pain Management Best Practices, there is opportunity to use alternative pain therapies without the risks of opioid-induced side effects to improve work productivity.Keywords: opioids, pain, disability, productivity

To date, COVID-19 has spread to more than 108 million people globally, with a death toll surpassing 2 1/2 million. With the United States Food and Drug Administration (FDA) approval of two highly effective COVID-19 vaccines from Pfizer-BioNtech and Moderna, we now have a novel approach to contain COVID-19 related morbidity and mortality. Chronic pain care has faced unprecedented challenges for patients and providers in this ever-changing climate. With the approval of COVID-19 vaccines, we now face questions relating to the potential effects of pain treatments utilizing steroids on vaccine efficacy. In this analysis, we address these issues and provide guidance for steroid therapies based on available data and expert recommendations., Video abstract Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/I045uXVqKQY

Multidisciplinary patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The use of multidisciplinary patient-reported outcomes is recommended in many areas of medicine. The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has been utilized as a common measurement language across universally relevant domains, including pain, mood, sleep, social participation, and function.Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into chronic pain centers across 24 sites in the United States. The PROMIS-29 v2.1 and the numerical rating scale (NRS) were recorded. The pain impact score and the Health Utilities Index Mark 3 (HUI-3) were calculated. Statistical differences were assessed between genders and among age groups comprising subjects less than 40, 41-60, 61-80, and over 80 years of age.A total of 19,546 patients were assessed over the enrollment period from 2018 to 2020. The PROMIS-29 v2.1 was evaluated across the seven domains, along with the numerical rating sale (NRS). The mean scores of the population for PROMIS SF v1.0 Pain Interference 4a, PROMIS SF v1.0 Sleep Disturbance 4a, PROMIS SF v1.0 Fatigue 4a, PROMIS SF v1.0 Anxiety 4a, PROMIS SF V1.0 Depression 4a, PROMIS SF v2.0 Ability to Participate in Social Roles and Activities 4a, and PROMIS SF v1.0 Physical Function 4a, measuring pain interference, sleep disturbance, fatigue, anxiety, depression, social participation, and physical function, were 64.61, 57.19, 58.50, 53.94, 54.45, 40.06, and 36.23, respectively. Pain intensity was 6.38 on an 11-point NRS scale. The pain impact score (PIS) and health utilities index mark 3 (HUI-3) scores, calculated across the designated age groups, were 33.19 and 0.67, respectively. Statistical differences were observed for the domains of sleep disturbance and physical function for age groups less than 40 and greater than 80 years of age.This data set is the first published normative data set describing the PROMIS-29 assessment in the chronic pain population. The patient population is more homogeneous than expected, and females were found to have higher levels of dysfunction.

ObjectiveTo conduct a systematic literature review of spinal cord stimulation (SCS) for pain.DesignGrade the evidence for SCS.MethodsAn international, interdisciplinary work group conducted literature searches, reviewed abstracts, and selected studies for grading. Inclusion/exclusion criteria included randomized controlled trials (RCTs) of patients with intractable pain of greater than one year’s duration. Full studies were graded by two independent reviewers. Excluded studies were retrospective, had small numbers of subjects, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques–Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria.ResultsSCS has Level 1 evidence (strong) for axial back/lumbar radiculopathy or neuralgia (five high-quality RCTs) and complex regional pain syndrome (one high-quality RCT).ConclusionsHigh-level evidence supports SCS for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, SCS was more effective than reoperation or medical management. New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional SCS for patients with axial back pain, with or without radicular pain.

Objectives To evaluate the evidence for morphine and ziconotide as firstline intrathecal (IT) analgesia agents for patients with chronic pain. Methods Medline was searched (through July 2017) for “ziconotide” or “morphine” AND “intrathecal” AND “chronic pain,” with results limited to studies in human populations. Results The literature supports the use of morphine (based primarily on noncontrolled, prospective, and retrospective studies) and ziconotide (based on randomized controlled trials and prospective observational studies) as first-choice IT therapies. The 2016 Polyanalgesic Consensus Conference (PACC) guidelines recommended both morphine and ziconotide as firstline IT monotherapy for localized and diffuse chronic pain of cancer-related and non–cancer-related etiologies; however, one consensus point emphasized ziconotide use, unless contraindicated, as firstline IT therapy in patients with chronic non–cancer-related pain. Initial IT therapy choice should take into consideration individual patient characteristics (e.g., pain location, response to previous therapies, comorbid medical conditions, psychiatric history). Trialing is recommended to assess medication efficacy and tolerability. For both morphine and ziconotide, the PACC guidelines recommend conservative initial dosing strategies. Due to its narrow therapeutic window, ziconotide requires careful dose titration. Ziconotide is contraindicated in patients with a history of psychosis. IT morphine administration may be associated with serious side effects (e.g., respiratory depression, catheter tip granuloma), require dose increases, and cause dependence over time. Conclusion Based on the available evidence, morphine and ziconotide are recommended as firstline IT monotherapy for cancer-related and non–cancer-related pain. The choice of first-in-pump therapy should take into consideration patient characteristics and the advantages and disadvantages of each medication.

Burst stimulation, as described by DeRidder, is a novel waveform made up of closely spaced, high-frequency electrical impulses delivered in packets, which are followed by a quiescent period or interburst interval. Electrically generated burst waveforms were initially designed to treat neural pathology in the auditory cortex and were later applied to the spinal cord through spinal cord stimulation (SCS) devices to treat chronic pain states. When Burst stimulation is applied to the spinal cord, the impulses travel to the thalamus and then diverge, targeting both the somatosensory cortex and the limbic system where they treat both the sensory, affective and attentional components of neuropathic pain. Areas covered: Literature examining clinical and basic research findings with the application of Burst stimulation to pathologically active central neural tissue was found using bibliographic databases including PubMed, Medline, Cochrane, Embase and Google Scholar. Expert commentary: Burst stimulation offers a salvage strategy for failed tonic spinal cord stimulation (tSCS), thus improving both quality of life and cost-effectiveness of SCS by reducing explant rates. The goal of this therapy is to use more than one waveform in the same device so that lost efficacy from tSCS can be salvaged.

Introduction Intrathecal therapy is an important part of the pain treatment algorithm for chronic disease states. The use of this option is a viable treatment strategy, but it is inherent for pain physicians to understand risk assessment and mitigation. In this manuscript, we explore evidence and mitigating strategies to improve safety with intrathecal therapy. Methods A robust literature search was performed covering January 2011 to October 9, 2016, in PubMed, Embase, MEDLINE, Biomed Central, Google Scholar, Current Contents Connect, and International Pharmaceutical Abstracts. The information was cross-referenced and compiled for evidence, analysis, and consensus review, with the intent to offer weighted recommendations and consensus statements on safety for targeted intrathecal therapy delivery. Results The Polyanalgesic Consensus Conference has made several best practice recommendations to improve care and reduce morbidity and mortality associated with intrathecal therapy through all phases of management. The United States Prevention Service Task Force evidence level and consensus strength assessments are offered for each recommendation. Conclusion Intrathecal therapy is a viable and relatively safe option for the treatment of cancer- and noncancer-related pain. Continued research and expert opinion are required to improve our current pharmacokinetic and pharmacodynamic model of intrathecal drug delivery, as this will undoubtedly improve safety and efficacy.

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.

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.