Preoperative hemoglobin A1c and perioperative blood glucose in patients with diabetes mellitus undergoing spinal cord stimulation surgery: A literature review of surgical site infection risk.

AIMS: The aim of our study was to review the surgical literature regarding the relationship between hemoglobin A1c (HbA1c), diagnosis of diabetes mellitus (DM), and risk of postoperative surgical site infection (SSI). METHODS: A librarian-assisted literature search was performed with two goals: (1) identify surgical publications related to SSI and HbA1c values, and (2) identify publications reporting infection risk with DM in spinal cord stimulation (SCS), intrathecal drug delivery systems (IDDS), and cardiovascular implantable electronic device (CIED) implantation surgeries. Published guidelines on perioperative management of DM are reviewed. RESULTS: We identified 30 studies reporting SSI and HbA1c values. The literature review indicated that for many surgical procedures, elevated HbA1c is not correlated to rate of SSI. We identified 16 studies reporting infection rates within DM cohorts following SCS, IDDS, and CIED implantation surgeries. The data reviewed did not indicate DM as an independent risk factor for SSI. CONCLUSION: Preoperative HbA1c levels in patients with a history of DM is not a singularly sufficient tool to estimate risk of perioperative infection in SCS implantation surgery. Published guidelines on perioperative management of DM do not suggest a specific HbA1c above which surgery should be delayed; intentional perioperative glycemic control is recommended.

Ten kHz spinal cord stimulation for the treatment of chronic peripheral polyneuropathy: 12-Month results from prospective open-label pilot study.

BACKGROUND: The goal of this study was to demonstrate that the paresthesia-independent 10 kHz spinal cord stimulation (SCS) can provide long-term pain relief in patients with peripheral polyneuropathy (PPN). Clinically diagnosed subjects with PPN refractory to conventional medical management were enrolled in this prospective, multicenter study between November 2015 and August 2016, after institutional review board approval and patient informed consent were obtained. METHODS: Subjects underwent trial stimulation utilizing 2 epidural leads, and if successful, were implanted with a permanent 10 kHz SCS system and followed up for 12 months post-implant. Outcome measures included adverse events, pain, neurological assessments, disability, function, quality of life, pain interference, sleep, satisfaction, and global impression of change. Data are presented as descriptive statistics. Permanent implant population results are reported as mean ± standard error. RESULTS: Twenty-one of the 26 trialed subjects had a successful trial and 18 received a permanent implant. All subjects had the leads placed anatomically without the need for paresthesia. Subjects experienced significant and sustained pain relief (at least 65% at all timepoints) whereas physicians noted improvements in neurological function. Significant improvements in disability, function, sleep, sensory, and affective dimensions of pain were reported at all timepoints. All adverse events were resolved without sequelae. CONCLUSION: Findings from this study suggest that 10 kHz SCS may provide sustained pain relief and disability improvements in patients suffering from PPN.

High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial.

BACKGROUND: Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP. OBJECTIVE: To compare 10-kHz SCS plus CMM (10-kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness. STUDY DESIGN: Multicenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10-kHz SCS + CMM or CMM alone. Optional crossover occurs at 6 months if treatment does not achieve ≥50% pain relief. METHODS: Patients with NSRBP as defined above may be enrolled if they are ineligible for surgery based on surgical consultation. Subjects randomized to 10-kHz SCS + CMM will receive a permanent implant if sufficient pain relief is achieved in a temporary trial. Both groups will receive CMM per standard of care and will undergo assessments at baseline and at follow-ups to 12 months. Self-report outcomes include pain, disability, sleep, mental health, satisfaction, healthcare utilization, and quality of life. RESULTS: Enrollment was initiated on September 10, 2018. Prespecified independent interim analysis at 40% of the enrollment target indicated the sample size was sufficient to show superiority of treatment at the primary endpoint; therefore, enrollment was stopped at 211. CONCLUSIONS: This large multicenter RCT will provide valuable evidence to guide clinical decisions in NSRBP.

10 kHz Spinal Cord Stimulation for the Treatment of Failed Back Surgery Syndrome with Predominant Leg Pain: Results from a Prospective Study in Patients from the Dutch Healthcare System.

INTRODUCTION: Persistent back/and or leg pain is a common outcome after spinal surgery (otherwise known as failed back surgery syndrome [FBSS]). Studies have shown that spinal cord stimulation (SCS) at 10 kHz provides effective analgesia in FBSS patients with both back and leg pain symptoms and in those with predominant back pain. This study is the first to evaluate the therapy in FBSS patients with predominant leg pain. METHODS: The safety and efficacy of 10 kHz SCS was evaluated in an uncontrolled, open-label, prospective study of FBSS patients with predominant leg pain in the Netherlands. Follow-ups were performed at 1, 3, 6, and 12 months post implantation. RESULTS: Sixty out of 68 patients (88%) experienced sufficient pain relief during a stimulation trial. Of these, 58 proceeded to permanent implantation of a 10 kHz SCS system. After 12 months of treatment, 80% of patients experienced ≥ 50% reduction in baseline leg pain, and a similar proportion (76%) experienced ≥ 50% reduction in baseline back pain. At least two-thirds of patients were also leg pain and back pain remitters (visual analog scale [VAS] ≤ 2.5 cm). The therapy was also associated with a general improvement in patients' quality of life, as measured by secondary outcomes including disability, perception of health improvement, mental well-being, and satisfaction. A positive impact on opioid consumption was also observed. CONCLUSIONS: Consistent with previous findings, 10 kHz SCS for the treatment of FBSS patients with predominant radicular symptoms is safe and effective and is associated with improved quality of life.

10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.

PURPOSE: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. METHODS: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. RESULTS: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. CONCLUSIONS: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.

Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Novel Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin.

INTRODUCTION: Currently available central nervous system treatment strategies are often insufficient in management of peripheral neuropathic pain, prompting a resurgence of neuromodulation focused on peripheral pain. A new peripheral nerve stimulation device was investigated in a prospective, randomized, double blind, crossover study, looking specifically at efficacy and safety, with Food and Drug Administration oversight. METHODS: Prospective, multicenter, randomized, double-blind, partial crossover study to assess safety and efficacy. After IRB approval, patients were enrolled, implanted, and then followed for three months to assess efficacy and one year for safety based on Food and Drug Administration guidance. RESULTS: One hundred forty-seven patients were consented and screened for the study. Thirty-five did not meet inclusion or exclusion criteria. Ninety-four patients were implanted and then randomized to the treatment (45) or the Control group (49). The primary efficacy endpoint, three months after randomization to treatment, demonstrated that patients receiving active stimulation achieved a statistically significantly higher response rate of 38% vs. the 10% rate found in the Control group (p = 0.0048). Improvement in pain was statistically significant between the randomized groups, with the Treatment group achieving a mean pain reduction of 27.2% from Baseline to Month 3 compared to a 2.3% reduction in the Control group (p < 0.0001). During the partial crossover period, patients again demonstrated statistically significant improvement in pain relief with active stimulation compared to baseline. Further, the Treatment group had significantly better improvement than the Control group in secondary measures including but not limited to quality of life and satisfaction. Safety, assessed throughout the trial and with follow-up to one year, demonstrated no serious adverse events related to the device. All device-related adverse events were minor and self-limiting. CONCLUSION: The novel peripheral nerve stimulation device is a safe and effective treatment strategy to address neuropathic pain of peripheral nerve origin.

Successful Discontinuation of Systemic Opioids After Implantation of an Intrathecal Drug Delivery System.

INTRODUCTION: An implantable drug delivery system (IDDS) provides an alternate route of opioid administration for patients with chronic pain. We collected data on systemic opioid use before and after IDDS implantation; patients who successfully discontinued systemic opioids; and physician support of discontinuation. METHODS: This was a single-center, retrospective chart review of 99 consecutive patients who used IDDSs for at least six months. Data collection included pre/postimplant systemic opioid use and pain scores, and patient demographic and clinical characteristics. RESULTS: The study population averaged 67 years of age, was 68% women, and 77% were Medicare beneficiaries. Ninety-five percent of patients had low back pain, and 86% had limb pain. The majority (81%) had pain for >5 years. Failed treatments included epidural injections (74%), lumbar spine surgery (46%), spinal cord stimulation (14%), and facet joint injections (11%), with 84% also reporting significant systemic opioid side-effects. All patients taking long-acting opioids discontinued these within one month of implant. Total systemic opioid elimination was accomplished by 68% of patients at one month postimplant, 84% at one year, and 92% at five years. At one month postimplant, 60% of patients reported decreased pain (mean change: -4.07), and at one year, 64% did (mean change: -3.42). CONCLUSIONS: IDDS can provide significant and lasting pain relief and an alternate route of delivery compared with systemic opioids with their associated side-effects. We demonstrated that systemic opioid elimination could be accomplished after IDDS implantation in the majority of cases through appropriate patient selection, monitoring, and participation.

Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures.

OBJECTIVE: To compare health-care expenditures over a 12-month horizon for chronic pain patients with implanted intrathecal drug delivery systems (IDDS) who eliminated or continued systemic opioids postimplant. METHODS: Claims data from commercial and Medicare databases were searched for patients who had an IDDS, used systemic opioids before implant, and had 12 months pre- and 13 months postimplant continuous medical and pharmacy coverage. The number and characteristics of patients who eliminated or continued systemic opioids were determined at four times postimplant: 30 days (allowing a systemic opioid washout period), 120 days, 150 days, and 210 days. Multivariable models evaluated the effect of eliminating opioids on health-care expenditures at each of those times. RESULTS: Three hundred eighty-nine patients met inclusion criteria, and 51% completely eliminated systemic opioids (12% within the 30-day washout and an additional 39% by the end of the one-year horizon). Systemic opioid elimination within 120 to 210 days postimplant was associated with a reduction of $3,388 to $4,465 in inpatient and outpatient expenditures, and $4,689 to $5,571 in inpatient, outpatient, and drug expenditures. CONCLUSIONS: Fifty-one percent of patients completely eliminated systemic opioids in the year after IDDS implant. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.

Current challenges in spinal cord stimulation.

OBJECTIVES: This study aims to review the current state of spinal cord stimulation for the treatment of chronic pain associated with failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS) and to describe intraspinal targets and stimulation parameters, patient selection, therapy cost-effectiveness, and strategies to improve outcomes. MATERIALS AND METHODS: We drew on professional literature spanning four decades, our work with national and international professional societies, and our own extensive clinical experience to summarize contemporary knowledge of the safety, efficacy, cost-efficiency, and challenges associated with spinal cord stimulation in treating chronic pain. RESULTS: The safety, efficacy, and cost-efficiency of spinal cord stimulation in treating chronic pain associated with FBSS and CRPS are well established through randomized controlled trials and long-term observational studies. Challenges include reducing wait-times before implant, which are associated with lower success rates; increasing awareness of this therapy among referring physicians, patients, and payers; decreasing device-related complications by incorporating advanced technology, improved operative and trialing techniques, and appropriate patient selection; and capturing functional and quality-of-life outcomes. Spinal cord stimulation must be part of an overall treatment plan to manage chronic pain, and must engage physicians, patients, their families, pharmacists, nursing staff, and mental health experts in supporting a return to employment, if possible, and to a full domestic and social life. CONCLUSIONS: Innovation in spinal cord stimulation therapy has intensified with numerous new technical capabilities, safety advances, and novel stimulation targets. This progress holds hope for the many sufferers of chronic pain.

Best practices for intrathecal drug delivery for pain.

OBJECTIVE: The objective of this study was to identify best practices and provide guidance to clinicians to ensure safety and optimize intrathecal drug delivery for chronic intractable pain. METHODS: Twelve experienced pain medicine practitioners-eight anesthesiologists, one neurosurgeon, one physiatrist, one clinical psychologist, and one advanced practice registered nurse-from the United States, Australia, and Europe gathered to identify and publish consensus on best practices in three areas related to safe intrathecal therapy for pain: safety and monitoring, patient and device management, and patient selection and trialing. CONCLUSIONS: Intrathecal drug delivery is a valuable alternative drug delivery system for many patients with severe chronic or end-of-life pain. While device-related complications (mostly with catheters) and surgical-site infections can occur, the main therapy-related safety issues associated with intrathecal drug delivery arise primarily with inadequate patient monitoring (e.g., respiratory depression), inflammatory mass (e.g., high doses and concentrations of opioids), wound healing, dosing errors (e.g., medication concentration and pump programming), pump fills or refills (e.g., pocket fills), and interaction with concomitant systemic medications (e.g., opioids and benzodiazepines). Many of the reported adverse events and complications of intrathecal drug delivery can be prevented by adequate clinician training, implementation of best practices, and experience. In adopting the therapy, patients must be apprised of its risks and benefits. Physicians and patients must partner to achieve both safety and effectiveness.

The appropriate use of neurostimulation: new and evolving neurostimulation therapies and applicable treatment for chronic pain and selected disease states. Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The International Neuromodulation Society (INS) has determined that there is a need to provide an expert consensus that defines the appropriate use of neuromodulation technologies for appropriate patients. The Neuromodulation Appropriateness Consensus Committee (NACC) was formed to give guidance to current practice and insight into future developments. METHODS: The INS executive board selected members of the international scientific community to analyze scientific evidence for current and future innovations and to use clinical experience to fill in any gaps in information. The NACC used PubMed and Google Scholar to obtain current evidence in the field and used clinical and research experience to give a more complete picture of the innovations in the field. RESULTS: The NACC has determined that currently approved neurostimulation techniques and technologies have expanded our ability to treat patients in a more effective and specific fashion. Despite these advances, the NACC has identified several additional promising technologies and potential applications for neurostimulation that could move this field forward and expand the applicability of neuromodulation. CONCLUSIONS: The NACC concludes that the field of neurostimulation is an evolving and rapidly changing one that will lead to improved patient access, safety, and outcomes.

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.

The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The International Neuromodulation Society (INS) has determined that there is a need for guidance regarding safety and risk reduction for implantable neurostimulation devices. The INS convened an international committee of experts in the field to explore the evidence and clinical experience regarding safety, risks, and steps to risk reduction to improve outcomes. METHODS: The Neuromodulation Appropriateness Consensus Committee (NACC) reviewed the world literature in English by searching MEDLINE, PubMed, and Google Scholar to evaluate the evidence for ways to reduce risks of neurostimulation therapies. This evidence, obtained from the relevant literature, and clinical experience obtained from the convened consensus panel were used to make final recommendations on improving safety and reducing risks. RESULTS: The NACC determined that the ability to reduce risk associated with the use of neurostimulation devices is a valuable goal and possible with best practice. The NACC has recommended several practice modifications that will lead to improved care. The NACC also sets out the minimum training standards necessary to become an implanting physician. CONCLUSIONS: The NACC has identified the possibility of improving patient care and safety through practice modification. We recommend that all implanting physicians review this guidance and consider adapting their practice accordingly.

Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation.

BACKGROUND: Painful diabetic neuropathy (PDN) can result in the loss of protective sensation, in which people are at twice the likelihood of foot ulceration and three times the risk of lower extremity amputation. Here, we evaluated the long-term effects of high-frequency (10 kHz) paresthesia-independent spinal cord stimulation (SCS) on protective sensation in the feet and the associated risk of foot ulceration for individuals with PDN. METHODS: The SENZA-PDN clinical study was a randomized, controlled trial in which 216 participants with PDN were randomized to receive either conventional medical management (CMM) alone or 10 kHz SCS plus CMM, with optional treatment crossover after 6 months. At study visits (baseline through 24 months), 10-g monofilament sensory assessments were conducted at 10 locations per foot. Two published methods were used to evaluate protective sensation via classifying risk of foot ulceration. RESULTS: Participants in the 10 kHz SCS group reported increased numbers of sensate locations as compared to CMM alone (P < .001) and to preimplantation (P < .01) and were significantly more likely to be at low risk of foot ulceration using both classification methods. The proportion of low-risk participants approximately doubled from preimplantation to 3 months postimplantation and remained stable through 24 months (P ≤ .01). CONCLUSIONS: Significant improvements were observed in protective sensation from preimplantation to 24 months postimplantation for the 10 kHz SCS group. With this unique, disease-modifying improvement in sensory function, 10 kHz SCS provides the potential to reduce ulceration, amputation, and other severe sequelae of PDN. TRIAL REGISTRATION: The SENZA-PDN study is registered on ClinicalTrials.gov with identifier NCT03228420.

Durable responses at 24 months with high-frequency spinal cord stimulation for nonsurgical refractory back pain.

OBJECTIVE: The objective of this study was to evaluate the 24-month durability of pain relief, function, quality of life, and safety outcomes for patients with nonsurgical refractory back pain (NSRBP) treated with high-frequency spinal cord stimulation (SCS) within a large, national, multicenter randomized controlled trial (RCT). METHODS: Following the completion of an RCT comparing high-frequency SCS plus CMM with CMM alone for the treatment of NSRBP, patients gave additional consent for a follow-up extension to 24 months. Presented is the cohort analysis of all patients treated with high-frequency SCS following the optional crossover at 6 months. The outcomes assessed to 24 months included responder rate of ≥ 50% pain relief measured according to the visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), quality of life (EQ-5D 5-level [EQ-5D-5L]), opioid reduction. RESULTS: Of the 125 patients who received a permanent implant, 121 completed the 12-month follow-up, 101 gave additional consent for extended follow-up, and 98 completed the 24-month follow-up. At 24 months after implantation, the mean back pain VAS score was reduced by 73% and the responder rate was 82%. ODI and EQ-5D-5L both improved by at least double the minimal clinically important difference for each measure. No unexpected adverse events were observed, and the rates of serious adverse events (3.4%) and device explantations (4.8%) were low. CONCLUSIONS: The addition of high-frequency SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality of life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.

Comparison of a novel fixation device with standard suturing methods for spinal cord stimulators.

INTRODUCTION: Spinal cord stimulation is a well-established treatment for chronic neuropathic pain of the trunk or limbs. Currently, the standard method of fixation is to affix the leads of the neuromodulation device to soft tissue, fascia or ligament, through the use of manually tying general suture. A novel semiautomated device is proposed that may be advantageous to the current standard. Comparison testing in an excised caprine spine and simulated bench top model was performed. MATERIALS AND METHODS: Three tests were performed: 1) perpendicular pull from fascia of caprine spine; 2) axial pull from fascia of caprine spine; and 3) axial pull from Mylar film. Six samples of each configuration were tested for each scenario. Standard 2-0 Ethibond was compared with a novel semiautomated device (Anulex fiXate). Upon completion of testing statistical analysis was performed for each scenario. RESULTS: For perpendicular pull in the caprine spine, the failure load for standard suture was 8.95 lbs with a standard deviation of 1.39 whereas for fiXate the load was 15.93 lbs with a standard deviation of 2.09. For axial pull in the caprine spine, the failure load for standard suture was 6.79 lbs with a standard deviation of 1.55 whereas for fiXate the load was 12.31 lbs with a standard deviation of 4.26. For axial pull in Mylar film, the failure load for standard suture was 10.87 lbs with a standard deviation of 1.56 whereas for fiXate the load was 19.54 lbs with a standard deviation of 2.24. CONCLUSIONS: These data suggest a novel semiautomated device offers a method of fixation that may be utilized in lieu of standard suturing methods as a means of securing neuromodulation devices. Data suggest the novel semiautomated device in fact may provide a more secure fixation than standard suturing methods.

Health care resource utilization and costs in patients with painful diabetic neuropathy treated with 10 kHz spinal cord stimulation therapy.

BACKGROUND: Diabetic peripheral neuropathy, a common comorbidity of diabetes, is a neurodegenerative disorder that targets sensory, autonomic, and motor nerves frequently associated with painful diabetic neuropathy (PDN). PDN carries an economic burden as the result of reduced work and productivity. A recent multicenter randomized controlled trial, SENZA-PDN (NCT03228420), assessed the impact of high-frequency (10 kHz) spinal cord stimulation (SCS) on pain relief. The effects of high-frequency SCS on health care resource utilization and medical costs are not known. OBJECTIVE: To evaluate the effect of high-frequency (10 kHz) SCS on health care resource utilization (HRU) and medical costs in patients with PDN using data from the SENZA-PDN trial. METHODS: Participants with PDN were randomly assigned 1:1 to receive either 10 kHz SCS plus conventional medical management (CMM) (SCS treatment group) or CMM alone (CMM treatment group). Patient outcomes and HRU up to the 6-month follow-up are reported here. Costs (2020 USD) for each service was estimated based on publicly available Medicare fee schedules, Medicare claims data, and literature. HRU metrics of inpatient and outpatient contacts and costs are reported as means and SDs. Univariate and bivariate analyses were used to compare SCS and CMM treatment groups at 6 months. RESULTS: At 6-month follow up, the SCS arm experienced approximately half the mean rate of hospitalizations per patient compared with the CMM treatment group (0.08 vs 0.15; P = 0.066). The CMM treatment group's total health care costs per patient were approximately 51% higher compared with the SCS treatment group (equivalent to mean annual cost per patient of $9,532 vs $6,300). CONCLUSIONS: Our analysis of the SENZA-PDN trial indicates that the addition of 10 kHz SCS therapy results in lower rates of hospitalization and consequently lower health care costs among patients with PDN compared with those receiving conventional management alone.

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial.

AIMS: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). METHODS: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding. RESULTS: At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection. CONCLUSIONS: Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN. TRIAL REGISTRATION: ClincalTrials.gov Identifier, NCT03228420.

Polyanalgesic Consensus Conference--2012: recommendations to reduce morbidity and mortality in intrathecal drug delivery in the treatment of chronic pain.

INTRODUCTION: Targeted intrathecal drug infusion to treat moderate to severe chronic pain has become a standard part of treatment algorithms when more conservative options fail. This therapy is well established in the literature, has shown efficacy, and is an important tool for the treatment of both cancer and noncancer pain; however, it has become clear in recent years that intrathecal drug delivery is associated with risks for serious morbidity and mortality. METHODS: The Polyanalgesic Consensus Conference is a meeting of experienced implanting physicians who strive to improve care in those receiving implantable devices. Employing data generated through an extensive literature search combined with clinical experience, this work group formulated recommendations regarding awareness, education, and mitigation of the morbidity and mortality associated with intrathecal therapy to establish best practices for targeted intrathecal drug delivery systems. RESULTS: Best practices for improved patient care and outcomes with targeted intrathecal infusion are recommended to minimize the risk of morbidity and mortality. Areas of focus include respiratory depression, infection, granuloma, device-related complications, endocrinopathies, and human error. Specific guidance is given with each of these issues and the general use of the therapy. CONCLUSIONS: Targeted intrathecal drug delivery systems are associated with risks for morbidity and mortality that can be devastating. The panel has given guidance to treating physicians and healthcare providers to reduce the incidence of these problems and to improve outcomes when problems occur.