A Systematic Guideline by the ASPN Workgroup on the Evidence, Education, and Treatment Algorithm for Painful Diabetic Neuropathy: SWEET.

Introduction: Painful diabetic neuropathy (PDN) is a leading cause of pain and disability globally with a lack of consensus on the appropriate treatment of those suffering from this condition. Recent advancements in both pharmacotherapy and interventional approaches have broadened the treatment options for PDN. There exists a need for a comprehensive guideline for the safe and effective treatment of patients suffering from PDN. Objective: The SWEET Guideline was developed to provide clinicians with the most comprehensive guideline for the safe and appropriate treatment of patients suffering from PDN. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations for PDN. A multidisciplinary group of international experts developed the SWEET guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Meeting Abstracts, and Scopus to identify and compile the evidence for diabetic neuropathy pain treatments (per section as listed in the manuscript) for the treatment of pain. Manuscripts from 2000-present were included in the search process. Results: After a comprehensive review and analysis of the available evidence, the ASPN SWEET guideline was able to rate the literature and provide therapy grades for most available treatments for PDN utilizing the United States Preventive Services Task Force criteria. Conclusion: The ASPN SWEET Guideline represents the most comprehensive review of the available treatments for PDN and their appropriate and safe utilization.

Relationship between number of prior lumbar spine surgeries and outcomes following spinal cord stimulator implantation: A multisite, retrospective pooled analysis.

OBJECTIVES: Lumbar spine surgery is a common procedure for treating disabling spine-related pain. In recent decades, both the number and cost of spine surgeries have increased despite technological advances and modification in surgical technique. For those patients that have continued uncontrolled back and/or lower extremity pain following lumbar spine surgery, spinal cord stimulation (SCS) has emerged as a viable treatment option. However, the impact of lumbar spine surgical history remains largely unstudied. Specifically, the current study considers the impact of number of prior lumbar spine surgeries on pain relief outcomes following SCS implantation. MATERIALS AND METHODS: We queried the electronic medical record of five separate pain practices for all patients who have undergone a SCS implant between January 1, 2017, and March 1, 2020. Inclusion criteria consisted of any patients with an SCS implant who underwent a prior lumbar spine surgery. The primary outcome was the mean calculated percentage pain relief in patients based on number of prior lumbar spine surgeries. RESULTS: There was a total of 1974 total SCS implant cases identified across five separate pain clinics. There was no difference in mean calculated pain relief in patients with one prior spine surgery versus those with two or more prior spine surgeries (28.2% vs. 25.8%, adjusted ß-coefficient -3.1, 95% CI -8.9 to 2.7, p = 0.290). Similarly, when analyzing number of spine surgeries as a continuous variable, there was no association between number of spine surgeries and calculated pain relief (adjusted ß-coefficient -1.5, 95% CI -4.0 to 1.1, p = 0.257). Additionally, after patients were stratified based on waveform, there was no association between number of prior lumbar spine surgeries (analyzed both as a categorical and continuous variable) and calculated percentage pain relief. CONCLUSIONS: This multicentered retrospective study found that there was no significant difference in pain scores in individuals who received SCS following one or more lumbar spine surgeries. Additionally, the waveform of the SCS device had no statistically significant impact on post-operative pain scores following one or more lumbar spine surgeries.

Artificial Intelligence and Pain Medicine: An Introduction.

Artificial intelligence was introduced 60 years ago and has evolved immensely since that time. While artificial intelligence is found in nearly all aspects of our life, the use of artificial intelligence in the healthcare industry has only recently become apparent and more widely discussed. It is expected that artificial intelligence will allow improved disease recognition, treatment optimization, cost and time savings, product development, decision making, and marketing. For pain medicine specifically, these same benefits will be translatable and we can expect better disease recognition and treatment selection. As adoption occurs with this impressive technology, it will be imperative for the pain medicine community to be informed on proper definitions and expected use cases for artificial intelligence. Our objective was to provide pain medicine physicians an overview of artificial intelligence, including important definitions to aid understanding, and to offer potential clinical applications pertinent to the specialty.

Posterior Lateral Arthrodesis as a Treatment Option for Lumbar Spinal Stenosis: Safety and Early Clinical Outcomes.

Introduction: Lumbar spinal stenosis (LSS) is a common condition caused by degenerative changes in the lumbar spine with age. LSS is caused by a variety of factors, including degenerative spondylosis and spondylolisthesis. People suffering with LSS experience neurogenic claudication, which causes severe physical limitations, discomfort, and a decrease in quality of life. Less invasive procedures are now being researched to improve the prognosis, success rate, and safety of LSS treatments. Posterior lateral spinal arthrodesis (PLSA) is a new surgical treatment for LSS. This study looks at the procedural and patient safety of PLSA. Materials and methods: This study is a multicenter retrospective analysis of the safety of PLSA who met the clinical indications for PLSA and underwent the procedure at eight interventional spine practices. Data was collected on demographical information, pre-procedural numeric rating scale score (NRS), post-procedural NRS, and complication reporting. Patients who were included had LSS with or without spondylolisthesis and had failed conservative treatments. A descriptive statistical analysis was performed to report the outcomes. Results were reported as mean and standard deviations for continuous outcomes, and frequency (%) for categorical outcomes. Results: This retrospective analysis involved 191 patients and 202 PLSA implants. The majority of patients were male Caucasians with a mean age of 69.2 years and a BMI of 31.1. A large majority of implants were placed at the L4-5 level, and the average pre-procedural NRS was 6.3 while the average post-procedural NRS was 3.1, indicating a 50.8% reduction in pain (p < 0.0001). Two patients reported complications, but they were unrelated to the device or surgical procedure; no infections, device malfunctions, or migrations were reported in the patient cohort. Conclusion: Preliminary results with PLSA implants indicate that it is a safe treatment option for patients with moderate LSS who do not respond to conservative management.

Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN).

Introduction: The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures. Objective: The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology. Methods: After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion. Results: Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders. Conclusion: Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient's specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs.

The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.

INTRODUCTION: The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant. METHODS: The EVOKE study was a multicenter, participant-blinded, investigator-blinded, and outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that compared ECAP-controlled CL-SCS with fixed-output OL-SCS. Participants with chronic, intractable back and leg pain refractory to conservative therapy were enrolled between January 2017 and February 2018, with follow-up through 36 months. The primary outcome was a reduction of at least 50% in overall back and leg pain. Holistic treatment response, a composite outcome including pain intensity, physical and emotional functioning, sleep, and health-related quality of life, and objective neural activation was also assessed. RESULTS: At 36 months, more CL-SCS than OL-SCS participants reported ≥50% reduction (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% to 43.9%, p<0.001) and ≥80% reduction (CL-SCS=49.3%, OL-SCS=31.3%; difference: 17.9, 95% CI 1.6% to 34.2%, p=0.032) in overall back and leg pain intensity. Clinically meaningful improvements from baseline were observed at 36 months in both CL-SCS and OL-SCS groups in all other patient-reported outcomes with greater levels of improvement with CL-SCS. A greater proportion of patients with CL-SCS were holistic treatment responders at 36-month follow-up (44.8% vs 28.4%), with a greater cumulative responder score for CL-SCS patients. Greater neural activation and accuracy were observed with CL-SCS. There were no differences between CL-SCS and OL-SCS groups in adverse events. No explants due to loss of efficacy were observed in the CL-SCS group. CONCLUSION: This long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months. Greater neural activation and increased accuracy of therapy delivery were observed with ECAP-controlled CL-SCS than OL-SCS. TRIAL REGISTRATION NUMBER: NCT02924129.

Core patient-reported outcome measures for chronic pain patients treated with spinal cord stimulation or dorsal root ganglia stimulation.

BACKGROUND: Neurostimulation is a highly effective therapy for the treatment of chronic Intractable pain, however, due to the complexity of pain, measuring a subject's long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects' pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to identify the reduced set of questions from multiple validated PROs that can accurately characterize chronic pain patients' responses to neurostimulation therapies. METHODS: Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with Spinal Cord Stimulation (SCS) or Dorsal Root Ganglia (DRG) neurostimulators enrolled in the prospective, international, post-market REALITY study (NCT03876054, Registration Date: March 15, 2019). A combination of linear regression, Pearson's correlation, and factor analysis were used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. RESULTS: The shortened versions of the questionnaires presented almost identical accuracy for classifying the therapy outcomes as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring neurostimulation therapy outcomes. CONCLUSIONS: PROs are important subjective measures to evaluate the physiological and psychological aspects of pain. However, these measures are cumbersome to collect. These shorter and more targeted PROs could result in better patient engagement, and enhanced and more frequent data collection processes for digital health platforms that minimize patient burden while increasing therapeutic benefits for chronic pain patients.

Percutaneous image-guided lumbar decompression and interspinous spacers for the treatment of lumbar spinal stenosis: A 2-year Medicare Claims Benchmark Study.

OBJECTIVE: This prospective longitudinal study compares outcomes between Medicare beneficiaries receiving percutaneous image-guided lumbar decompression (PILD) using the mild® procedure and a control group of patients receiving interspinous spacers for the treatment of lumbar spinal stenosis (LSS) with neurogenic claudication (NC). METHODS: Patients diagnosed with LSS with NC and treated with either the mild procedure or a spacer were identified in the Medicare claims database. The incidence of harms, the rate of subsequent interventions, and the overall combined rate of harms and subsequent interventions during 2-year follow-up after the index procedure were compared between the two groups and assessed for statistical significance with p = 0.05. RESULTS: The study included 2229 patients in the mild group and 3401 patients who were implanted with interspinous spacers. The rate of harms for those treated with the mild procedure was less than half that of patients implanted with a spacer (5.6% vs. 12.1%, respectively; p < 0.0001) during 2-year follow-up. The rate of subsequent interventions was not significantly different between the two groups (24.9% and 26.1% for the mild and spacer groups, respectively; p = 0.7679). The total rate of harms and subsequent interventions for mild was found to be noninferior to spacers (p < 0.0001). CONCLUSIONS: This comprehensive study of real-world Medicare claims data demonstrated a significantly lower rate of harms for the mild procedure compared to interspinous spacers for patients diagnosed with LSS with NC, and a similar rate of subsequent interventions during 2-year follow-up.

A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain.

BACKGROUND: Real-world data can provide important insights into treatment effectiveness in routine clinical practice. Studies have demonstrated that in multiple different pain indications temporary (60-day) percutaneous peripheral nerve stimulation (PNS) treatment can produce significant relief, but few real-world studies have been published. The present study is the first real-world, retrospective review of a large database depicting outcomes at the end of a 60-day PNS treatment period. OBJECTIVES: Evaluate outcomes during a 60-day PNS treatment in routine clinical practice. STUDY DESIGN: Secondary retrospective review. METHODS: Anonymized records of 6,160 patients who were implanted with a SPRINT PNS System from August 2019 through August 2022 were retrospectively reviewed from a national real-world database. The percentage of patients with ? 50% pain relief and/or improvement in quality of life was evaluated and stratified by nerve target. Additional outcomes included average and worst pain score, patient-reported percentage of pain relief, and patient global impression of change. RESULTS: Overall, 71% of patients (4,348/6,160) were responders with >= 50% pain relief and/or improvement in quality of life; pain relief among responders averaged 63%. The responder rate was largely consistent across nerve targets throughout the back and trunk, upper and lower extremities, and posterior head and neck. LIMITATIONS: This study was limited by its retrospective nature and reliance on a device manufacturer's database. Additionally, detailed demographic information and measures for pain medication usage and physical function were not assessed. CONCLUSIONS: This retrospective analysis supports recent prospective studies demonstrating that 60-day percutaneous PNS can provide significant relief across a wide range of nerve targets. These data serve an important role in complementing the findings of published prospective clinical trials.

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

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

Role of patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain: a comprehensive narrative review.

BACKGROUND/IMPORTANCE: Patient selection for spinal cord stimulation (SCS) therapy is crucial and is traditionally performed with clinical selection followed by a screening trial. The factors influencing patient selection and the importance of trialing have not been systematically evaluated. OBJECTIVE: We report a narrative review conducted to synthesize evidence regarding patient selection and the role of SCS trials. EVIDENCE REVIEW: Medline, EMBASE and Cochrane databases were searched for reports (any design) of SCS in adult patients, from their inception until March 30, 2022. Study selection and data extraction were carried out using DistillerSR. Data were organized into tables and narrative summaries, categorized by study design. Importance of patient variables and trialing was considered by looking at their influence on the long-term therapy success. FINDINGS: Among 7321 citations, 201 reports consisting of 60 systematic reviews, 36 randomized controlled trials (RCTs), 41 observational studies (OSs), 51 registry-based reports, and 13 case reports on complications during trialing were included. Based on RCTs and OSs, the median trial success rate was 72% and 82%, and therapy success was 65% and 61% at 12 months, respectively. Although several psychological and non-psychological determinants have been investigated, studies do not report a consistent approach to patient selection. Among psychological factors, untreated depression was associated with poor long-term outcomes, but the effect of others was inconsistent. Most RCTs except for chronic angina involved trialing and only one RCT compared patient selection with or without trial. The median (range) trial duration was 10 (0-30) and 7 (0-56) days among RCTs and OSs, respectively. CONCLUSIONS: Due to lack of a consistent approach to identify responders for SCS therapy, trialing complements patient selection to exclude patients who do not find the therapy helpful and/or intolerant of the SCS system. However, more rigorous and large studies are necessary to better evaluate its role.

Patient-Reported Satisfaction with Using a Rechargeable 10 kHz Spinal Cord Stimulation Device.

Introduction: Chronic pain is a common clinical condition and is frequently treated with a variety of medications, but pharmacotherapy is oftentimes not the optimal long-term treatment option. Safe and effective long-term pain relief for trunk and limb pain is available using high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS), which is delivered using a rechargeable implantable pulse generator (IPG). Although rechargeable devices have been shown to reduce patient risk and overall cost by eliminating the need for periodic surgeries to replace depleted non-rechargeable IPGs, there is little published evidence that rechargeable technology is practical and convenient for patients, especially in the context of 10 kHz SCS. Objective: This analysis of real-world patients implanted with 10 kHz SCS devices was undertaken using patient data from an industry-maintained database to investigate whether there was a substantial burden associated with rechargeable SCS and the degree of patient satisfaction or dissatisfaction with 10 kHz SCS. Results: This study included 10,391 men and women who were implanted with 10 kHz SCS devices to treat chronic pain of the trunk and/or limbs. They received stimulation for a median of 361 days (180-1550 days), and 65.48% had previous spine surgery. In this patient sample, most patients were satisfied with the efficacy of 10 kHz SCS, including 77% who would repeat the procedure and 71% who would recommend it to other patients with similar pain. In regards to IPG recharging, 70% were satisfied or very satisfied and 19% were neutral, and a majority of patients recharged their device daily for 30 to 60 minutes. Conclusion: These results indicate most patients do not find IPG recharging inconvenient or burdensome. In addition, IPG recharging is not a barrier to the majority of patients benefitting from 10 kHz SCS for long-term pain relief.

Comparison of Spinal Cord Stimulation Trial Reporting Protocols and Long-Term Pain Relief Outcomes Following Implantation.

OBJECTIVES: Appropriate spinal cord stimulation (SCS) candidates are required to undergo an SCS trial before implant, typically with ≥50% pain relief deemed "successful." However, SCS trialing protocols can vary substantially. The primary aim of this retrospective study is to investigate the associations between SCS trial results and long-term SCS pain outcomes. MATERIALS AND METHODS: This study was a retrospective single-center review of successful SCS trials from January 1, 2017, to July 1, 2019. A total of 115 patients were included. Group differences in continuous variables were evaluated using t-tests, and group differences in categorical variables were evaluated using the χ2 test. The percentage improvement in long-term pain intensity was analyzed as a binary variable, where long-term success was defined as ≥50% improvement in numeric rating scale pain scores. The level of significance for all tests was set at p < 0.05. RESULTS: The mean age was 64.9 years, and 52% of patients were men. The mean pain score at long-term follow-up was 4.7 ± 2.6, and the median time from implantation to follow-up was 13 months (25th-75th interquartile range; 4-22). In the logistic regression analysis adjusted for age, sex, and follow-up time, greater patient-reported percentage improvement in pain scale during the trial was significantly associated with greater odds of experiencing ≥50% improvement in pain scores (p = 0.048; 95% CI 1.00-1.70). All other assessed trial metrics were not significantly associated with greater odds of experiencing >50% improvement in pain scores at last follow-up. CONCLUSIONS: Given the variability in current assessment techniques, we recommend the patient-reported percentage improvement in pain scale as the posttrial assessment method of choice instead of a calculated percentage improvement. However, our results indicate that current trial assessment methods are generally poor, and improved trial reporting protocols must be sought.

Does Fibromyalgia Affect the Outcomes of Spinal Cord Stimulation: An 11-Year, Multicenter, Retrospective Matched Cohort Study.

BACKGROUND: Fibromyalgia is a prevalent disorder manifesting with widespread musculoskeletal pain and central sensitization, as well as fatigue, sleep issues, psychologic distress, and poor quality of life. Patients with fibromyalgia also may be diagnosed with other painful conditions amenable to treatment with spinal cord stimulation (SCS), although it is unclear how these patients respond to SCS compared with patients without fibromyalgia. MATERIALS AND METHODS: We performed an 11-year, multicenter, retrospective matched cohort study comparing SCS-treated patients with fibromyalgia and those without fibromyalgia. The primary outcome was comparison in mean calculated percentage pain relief between cohorts at six months after SCS implantation. Secondary outcomes included comparison of patient satisfaction between six and 12 months after SCS implantation, and percentage of patients reporting opioid intake and neuropathic medication intake at six months and 12 months after SCS implantation. Adjusted regression analysis was performed to make comparisons while adjusting for age, sex, body mass index, Charlson comorbidity index, preoperative opioid intake, and preoperative neuropathic medication intake. RESULTS: Of 90 patients with fibromyalgia who underwent SCS trial, 18 patients (20%) failed their SCS trial and did not proceed toward implantation. Sixty-eight patients with fibromyalgia were matched to 141 patients in the control cohort based on age, sex, Charlson comorbidity index, and the American Society of Anesthesiologists physical status score. At six months after SCS implantation, there was no statistical difference in calculated percentage change in pain intensity between the fibromyalgia cohort (46.6 ± 29.0) and the control cohort (50.9 ± 32.8; ß, -18.4; 95% CI, -44.3 to 7.6; p = 0.157). At baseline, a greater percentage of patients in the fibromyalgia cohort reported preoperative opioid intake (51.5% vs 22.7%, p < 0.001) and preoperative neuropathic medication intake (67.6% vs 15.6%, p < 0.001). However, there was no difference between cohorts in the percentage of patients taking opioid or neuropathic medications at six months and 12 months after SCS implantation. Similarly, there was no difference between cohorts in the percentage of patients reporting satisfaction between six and 12 months. CONCLUSION: Patients with fibromyalgia who received a diagnosis approved for treatment with SCS may expect similar post-SCS-implantation pain relief, overall satisfaction, and analgesic use rate to those of patients without fibromyalgia.

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.

A Bibliometric Analysis of Top-Cited Journal Articles Related to Neuromodulation for Chronic Pain.

OBJECTIVES: Since its foundation in the 1960s, neuromodulation has become an increasingly used treatment option for chronic pain. This bibliometric analysis examines the most cited research in this field with the aim of uncovering existing trends and future directions. MATERIALS AND METHODS: Clarivate's Web of Science data base was searched for the top 25 most cited studies focusing on neuromodulation for chronic pain. Various bibliometric parameters were then extracted and analyzed. Randomized controlled trials (RCTs) were compared with non-RCTs. RESULTS: The top 25 articles had a mean of 347 citations and 22.2 citations per year, with more recent articles having a higher citation rate. Most were published in the last two decades and predominantly originated from the United States. There were 13 RCTs, which were significantly more recent (p = 0.004) and more cited per year (p = 0.001) than the 12 non-RCTs. Sources included 15 journals with a mean impact factor of 13.896. The most studied modality was spinal cord stimulation with 20 articles (76.9%), followed by intrathecal drug delivery (15.4%), dorsal root ganglion stimulation (3.8%), and peripheral nerve stimulation (3.8%). CONCLUSIONS: Analysis of the most cited articles on neuromodulation reveals a focal shift from historical reports to innovative RCTs that have increasingly guided pain practice in the recent years. As novel techniques and technologies continue to develop, high-quality evidence coupled with broadening indications will likely direct further expansion of this field.

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

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