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.

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.

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society.

BACKGROUND: Peripheral nerve stimulation (PNS) is an effective neuromodulation therapy for chronic neuropathic and nociceptive pain. Although the total number of PNS implantations has increased over the last decade, no curriculum exists to guide training and learning of this therapy. The goal of the North American Neuromodulation Society (NANS) education committee is to develop a series of competency-based curriculums for neuromodulation therapies. The PNS curriculum is the latest part of such series, following the curriculums for spinal cord stimulation and intrathecal drug delivery system. MATERIALS AND METHODS: A multidisciplinary task force (anesthesiology, physical medicine and rehabilitation, neurosurgery, preventive medicine and public health, and neurology) was created by the educational committee of NANS to develop a PNS curriculum in accordance with the Accreditation Council for Graduate Medical Education (ACGME) milestones. The curriculum was created based on the best available evidence and expert knowledge (from our task force members) of available PNS systems. The final PNS curriculum was approved by the NANS board. RESULTS: A PNS curriculum was developed by the task force. Milestones included professionalism, practice-based learning, interpersonal communication, medical knowledge, systems-based practice, procedural skills, and patient care. Each milestone was defined into three categories: early learner, advanced learner, and practitioner. CONCLUSIONS: This manuscript provides a PNS training curriculum developed by a multidisciplinary task force of the NANS educational committee in accordance with the milestones described by ACGME for basic learners, advanced learners, and practitioners. This curriculum will help provide a structured training and evaluation process for obtaining proficiency in PNS treatment(s).

Telemedicine Implementation in Pain Medicine: A Survey Evaluation of Pain Medicine Practices in Spring 2020.

BACKGROUND: The COVID-19 pandemic resulted in a novel challenge for healthcare delivery and implementation in the United States (US) in 2020 and beyond. Telemedicine arose as a significant and effective medium for safe and efficacious physician-patient interactions. Prior to the COVID-19 pandemic, telemedicine while available, had infrequently been utilized in pain medicine practices due to difficulties with reimbursement, the learning curve associated with new technology usage, and the need for new logistical systems in place to implement telemedicine effectively. Given the unique constraints on the healthcare system during the COVID-19 pandemic, the ubiquitous utilization of telemedicine among pain medicine physicians increased, giving insight into potential future roles for the technology beyond the pandemic. OBJECTIVES: To survey and understand the state of implementation of telemedicine into pain medicine practices across practice settings and geographical areas; to identify potential barriers to the implementation of telemedicine in pain medicine practice; and to identify the likelihood of telemedicine continuing beyond the pandemic in pain medicine practice. STUDY DESIGN: Online questionnaire targeting Pain Medicine physicians in the US. Participants were asked questions related to the use of telemedicine during the first peak of the COVID-19 pandemic. SETTING: Online-based questionnaire distributed to academic and private practice pain medicine physicians nationally in the United States. METHODS: A 34 web-based questionnaires were distributed by the American Society of Regional Anesthesia and Pain Medicine and the Spine Intervention Society to all active members. Data were analyzed using SAS v9.4. RESULTS: Between December 3, 2020, and February 18, 2021, 164 participants accessed the survey with a response rate of 14.3%. Overall, academic physicians were more likely to implement telemedicine than private practice physicians. Telemedicine was also more frequently utilized for follow-up appointments rather than initial visits. LIMITATIONS: Although our n = 164, the overall low response rate of 14.3% warrants further investigation into the utilization of telemedicine throughout the COVID-19 pandemic. CONCLUSIONS: Telemedicine as an emerging technology for efficient communication played a key role in mitigating the adverse effects of the COVID -19 pandemic on chronic pain patients. The utilization of telemedicine remarkably increased after the start of the pandemic within 1 to 2 weeks. Overall, private hospital-based centers were significantly less likely to implement telemedicine than academic centers, possibly due to limited access to secure telemedicine platforms and high start-up costs. Telemedicine was used more frequently for follow-up visits than initial visit encounters at most centers. In spite of the unforeseen consequences to the healthcare system and chronic pain practices in the US from COVID-19, telehealth has emerged as a unique model of care for patients with chronic pain. Although it has flaws, telehealth has the ability to increase access to care beyond the end of the pandemic. Further identification of barriers to the use of telemedicine platforms in private practices should be addressed from a policy perspective to facilitate increased care access.

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial.

Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were "satisfied" or "very satisfied" with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420.

Novel Technologies in Interventional Pain Management.

This article comprehensively covers 3 major novel technologies and techniques in the management of chronic lower back pain. The first 2 procedures, percutaneous interspinous spacer implantation, and minimally invasive lumbar decompression have shown significant impact in the management of lumbar spinal stenosis (LSS), especially in patients who are not great surgical candidates or are otherwise not amenable to open spinal surgery. The wealth of data for these procedures continues to increase, with up to 4 to 6-year follow-up data recently being made available. A novel solution for vertebrogenic back pain is also discussed as follow-up data emphasizes the safety and sustainability of the procedure. This article also establishes a framework for evaluating novel technologies in interventional pain management.

Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time.

OBJECTIVE: This study was designed to assess whether using pulse dosing (PD) (regularly cycled intermittent stimulation) of high-frequency 10-kHz spinal cord stimulation (10-kHz SCS) can reduce device recharge time while maintaining efficacy in patients with chronic intractable back pain with or without leg pain. DESIGN: Prospective, multicenter, observational study. METHODS: Patients successfully using 10-kHz SCS at 100%ON (i.e., continuously with no PD) for >3 months were consecutively enrolled. After a 1-week baseline period of documenting their pain twice daily on a 0-10 numerical rating scale (NRS) using 100%ON of their "favorite" program, all subjects were reprogrammed to 14%PD for 10-14 days. If subjects preferred 14%PD to 100%ON, they were programmed to 3%PD; otherwise, they were programmed to 50%PD. Subjects used this next program for another 10-14 days. Subjects then entered a 3-month observational period during which they were requested to use but not limited to their most preferred %PD program. Toward the end of 3 months, subjects completed a 7-day NRS diary and indicated a final %PD program preference. Study endpoints included %PD preference, mean diary NRS by %PD, and daily minutes and patterns of charging. RESULTS: Of 31 subjects completing the study, 81% preferred less than 100%ON. Among the subjects, 39% preferred 3%PD, 32% preferred 14%PD, 10% preferred 50%PD, and 19% preferred 100%ON. Average daily charge durations were 8.3 ± 3.1 minutes for 3%PD, 13.9 ± 4.9 minutes for 14%PD, 26.2 ± 7.4 minutes for 50%PD, and 43.8 ± 10.9 minutes for 100%ON. Regression modeling suggested that pain relief was weighted as more than twice as influential as charging in preference for reduced %PD. CONCLUSIONS: This prospective study suggests that 10-kHz SCS therapy with PD may be successfully used in a large majority of 10-kHz SCS responders, maintaining efficacy while reducing device charging time by nearly two thirds.

Establishing a Dose-Response Relationship Between Opioid Use and Hypogonadism: A Retrospective Case-Control Study.

Background: Opioid-induced androgen deficiency (OPIAD) related to chronic, long-acting opioid use can be a significant detriment to patient quality of life. The aim of this study was to investigate the association between chronic opioid use and hypogonadism. Methods: A single-center, retrospective, matched case-control analysis of 357 males (94 cases, 263 controls, aiming for 1:4 matching) was performed. Study subjects were ages 18 to 80 years and had a diagnosis of chronic opioid use. Patients with a hypogonadism diagnosis were matched to patients without a hypogonadism diagnosis by age, ethnicity, and body mass index. The maximum morphine equivalent daily dose (MEDD) was compared in each group. Results: A significant linear association between MEDD and the odds of developing hypogonadism (P<0.001) in males with chronic use of opioids was observed, with an odds ratio of 1.44 (95% CI 1.16-1.78) by 100-unit difference in maximum MEDD. Conclusion: Results showed a significant, positive linear association between chronic opioid dose and the odds of developing hypogonadism in males. This higher index of suspicion of OPIAD could lead to earlier recognition of symptoms and increase the positive predictive value of diagnostic laboratory tests.

Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial.

Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). Design, Setting, and Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated. Interventions: Implanted medical device delivering 10-kHz SCS. Main Outcomes and Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months. Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001). Conclusions and Relevance: Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN. Trial Registration: ClincalTrials.gov Identifier: NCT03228420.

Diagnosis of Sacroiliac Joint Pain: Predictive Value of Three Diagnostic Clinical Tests.

INTRODUCTION: To date, there have been no acceptable and accurate diagnostic criteria or standards of care for the management of sacroiliac joint (SIJ) pain. Several studies have yielded different contributions of clinical presentation, history, and physical examination in the diagnosis of SIJ pain. Our goal in this study was to assess the sensitivity and specificity of the diagnostic clinical tests and their predictive value in accurately diagnosing SIJ pain. METHODOLOGY: Upon enrolling 200 eligible patients with SIJ pain as their primary diagnosis, they were re-evaluated and their verbal rating scale (VRS) pain scores and demographic data were obtained. Thereafter, three SIJ diagnostic tests were performed: the thigh thrust test, the Patrick test, and a modified version of the Gaenslen test that is referred to as the Mekhail test. Subsequently, the patients were taken to the procedure room to undergo SIJ injection, for which a confirmative result was ≥50% pain relief. The physicians performing the procedure were blinded of the results of the 3 tests performed. Results from the 3 tests were incorporated with the procedure results, from which we drew statistical and medical conclusions determining their predictive value and degree of aid to physicians in diagnosing SIJ pain. RESULTS: We found that the cumulative effect of adding simultaneous tests increased the sensitivity of the testing but decreased the specificity, which generates a powerful screening tool. The combination of the Patrick and Mekhail tests demonstrated the best accuracy, with 94% sensitivity, 17% specificity, 81% positive predictive value, and 44% negative predictive value. The Patrick test was better than other tests for differentiating patients with SIJ pain from those with non-SIJ pain. No combination yielded both significant sensitivity and specificity. Generally, the overall predictive value of any of the tests on their own or their combination did not vary significantly from the predictive value of baseline demographics, including pre-injection pain score and pain referral diagram. CONCLUSION: In conclusion, our study results were similar to those of previous investigators who found that physical examination plays a limited role in diagnosing SIJ pain. Specifically, we found that the clinical tests and/or their combinations added no significant predictive capacity compared to patients' baseline characteristics in predicting the response to diagnostic SIJ injection, albeit the combination of the Mekhail and Patrick tests yielded high sensitivity (94%), making them viable for consecutive screening, possibly reducing the unnecessary costs of diagnostic SIJ injection procedures.

Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation.

BACKGROUND: Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection. METHODS: Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment. RESULTS: Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001). CONCLUSIONS: CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

10-kHz Spinal Cord Stimulation for Chronic Postsurgical Pain: Results From a 12-Month Prospective, Multicenter Study.

BACKGROUND: Chronic postsurgical pain (CPSP) can be caused by peripheral nerve injury (PNI) resulting from surgical procedures and has a significant neuropathic component. This prospective, single-arm study was conducted to document the effectiveness of 10-kHz spinal cord stimulation (10-kHz SCS) as a treatment for patients with CPSP. METHODS: Subjects with CPSP who were refractory to conventional medical interventions and reported pain scores of ≥5 cm on a 10-cm VAS underwent trial stimulations lasting up to 14 days. Epidural leads were implanted at locations appropriate for the primary area of pain, and trials resulting in ≥40% pain relief were considered successful. Subjects with successful trials underwent implantation with a permanent 10-kHz SCS system and were followed for 12 months after implantation. RESULTS: Of the 34 subjects who underwent trial stimulation, 1 was withdrawn early and 29 (87.9%) had a successful trial and received a permanent implant. After 12 months of treatment, the mean VAS score decreased by 6.5 cm, the response rate was 88.0% (22/25), and 18 subjects (62.1%) were remitters with VAS scores sustained at ≤3.0 cm. Scores for all components of the short-form McGill Pain Questionnaire 2 were significantly reduced, including affective descriptors of pain. Pain catastrophizing and vigilance, patient function, physical and mental well-being, and sleep quality all improved over the course of the study. No neurologic deficits reported in the study. CONCLUSIONS: 10-kHz SCS is effective and tolerated in patients with CPSP, and further study of its clinical application in this population is warranted.

Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection.

BACKGROUND: Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections are two commonly used modalities to manage symptoms associated with knee OA. METHODS: A prospective 1:1 randomized study was conducted in 177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12 months. HA subjects with unsatisfactory outcomes at 6-months were allowed to crossover and receive CRFA. Knee pain (numeric rating scale = NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect = GPE, EQ-5D-5 L), and adverse events were measured. RESULTS: At 12-months, 65.2% of subjects in the CRFA cohort reported ≥50% pain relief from baseline. Mean NRS pain score was 2.8 ± 2.4 at 12 months (baseline 6.9 ± 0.8). Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint. 64.5% of subjects in the crossover cohort reported ≥50% pain relief from baseline, with a mean NRS pain score of 3.0 ± 2.4 at 12 months (baseline 7.0 ± 1.0). After receiving CRFA, subjects in the crossover cohort had a 27.5% improvement in total WOMAC score. All subjects receiving CRFA reported significant improvement in quality of life. There were no serious adverse events related to either procedure and overall adverse event profiles were similar. CONCLUSION: A majority of subjects treated with CRFA demonstrated sustained knee pain relief for at least 12-months. Additionally, CRFA provided significant pain relief for HA subjects who crossed over 6 months after treatment. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017.

Development of an Educational Curriculum for Spinal Cord Stimulation.

BACKGROUND: Spinal cord stimulators (SCSs) are used for treating chronic pain. The number of SCSs implanted each year is on the increase. The North American Neuromodulation Society (NANS) education committee aimed to develop a SCS curriculum as a tool to guide physicians at different training levels, based on the most recent evidence. MATERIAL AND METHODS: A multidisciplinary (anesthesiology, physical medicine, neurosurgery, and neurology), taskforce representing the education committee of the NANS met to develop a SCS curriculum following the Accreditation Council for Graduate Medical Education (ACGME) milestones. The task force used the best available evidence and knowledge to develop the curriculum. Once developed, the SCS curriculum was then approved by the NANS board. RESULTS: The task force developed a SCS training curriculum. Milestones included patient care and procedural skills, system-based practice, medical knowledge, interpersonal communication, practice based learning and professionalism. Each milestone was defined for three categories, early learner, advanced learner, and practitioner. CONCLUSION: A multidisciplinary task force of the NANS education committee developed a SCS training curriculum that defines ACGME milestones for basic learners, advanced learners, and practitioners.

A Rare Case of Transverse Sinus Venous Thrombosis Simulating Postdural Puncture Headache After Cervical Epidural Injection.

Postdural puncture headache (PDPH) is a feared complication related to epidural steroid injections. We report a unique case in which all subjective and objective findings indicated the diagnosis of PDPH. However, the patient failed appropriate conservative and interventional management. Therapeutic failure prompted further investigation to establish the correct diagnosis of cerebral venous sinus thrombosis. Cerebral venous sinus thrombosis is a rare, difficult to diagnose, but potentially lethal disorder with nonspecific and variable clinical presentations, including headache and focal neurological deficits. Performing magnetic resonance imaging and magnetic resonance venogram should be considered early, especially in patients who fail to respond to standard interventions for PDPH.

A Double-Blind Randomized Controlled Trial Comparing Epidural Clonidine vs Bupivacaine for Pain Control During and After Lower Abdominal Surgery.

BACKGROUND: Alpha-2 adrenergic agonists produce safe and effective analgesia, but most investigations studying the analgesic effect of alpha-2 adrenoceptor agonists postoperatively included previous or concomitant administration of other analgesics. Because clonidine potentiates the effect of these drugs, its own intrinsic analgesic effect has been difficult to establish. This study was designed to compare the intraoperative and postoperative effects of epidural clonidine vs bupivacaine for patients undergoing lower abdominal surgery. METHODS: This randomized controlled trial included 40 patients aged 18-50 who were scheduled for elective lower abdominal surgery. Patients were randomly divided into 2 groups. Group I (n=20) received epidural clonidine; Group II (n=20) received epidural bupivacaine. Intraoperative and postoperative hemodynamics, pain scores, and complications were monitored. RESULTS: Mean pain scores were significantly lower in Group I compared to Group II (1.5 ± 0.5 compared to 3.4 ± 1.0, respectively) in the first 12 hours after surgery. Sedation was more prominent in Group I until 9 hours after surgery. Opioid requirements were significantly lower in Group I. Respiratory rate was similar in the 2 groups. Group I had larger decreases from baseline in systolic blood pressure and diastolic blood pressure than Group II. Heart rate in Group I was reduced from baseline, while it was increased in Group II. Less postoperative nausea and vomiting, urinary retention, pruritus, and shivering were observed in Group I. CONCLUSION: Compared to bupivacaine, epidural clonidine provided effective intraoperative and postoperative analgesia in selected patients, resulting in a decreased intravenous pain medication requirement and prolonged duration of analgesia after epidural infusion was discontinued.

Stellate Ganglion Block for the Treatment of Hot Flashes in Patients with Breast Cancer: A Literature Review.

BACKGROUND: Currently, hormone replacement therapy (HRT) is the only US Food and Drug Administration-approved treatment for hot flashes, resulting in clinical improvement in 80%-90% of symptomatic women. However, HRT is not recommended for patients with breast cancer. Current data regarding the use of stellate ganglion block (SGB) for the treatment of vasomotor symptoms in symptomatic women with a diagnosis of breast cancer are promising. METHODS: A PubMed search for recent articles on the effects of SGB for the treatment of hot flashes in patients with breast cancer identified 11 articles published between 2005-2014. RESULTS: Five articles described the physiology of hot flashes and the hypothesis of why SGB would be a treatment option, and 6 were clinical articles. CONCLUSION: The available results of SGB efficacy are promising but demonstrate significant variability. A large prospective randomized controlled trial is required to determine the exact success of SGB on hot flashes and quality of life in breast cancer survivors.

Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: a retrospective analysis of 365 patients.

OBJECTIVES: Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified. MATERIALS AND METHODS: Patients with an ITP implanted at Cleveland Clinic Pain Management Center between January 1998 and December 2012 were included. ITP longevity was calculated as the time between implant and explant for depletion of the system's battery. Using the 2013 fee schedule of the Centers for Medicare & Medicaid Services, the daily cost of having a functioning ITP was calculated. The costs of office visits for pump refills and the cost of intrathecal medications were not included, nor were the possible savings due to decreased utilization of alternate medical services. RESULTS: Three hundred sixty-five patients had 559 pumps implanted. Postlaminectomy syndrome was the most common indication (40%). The median system longevity for all pumps was 5.4 years (97.5% confidence interval: [5.0, 5.8]), including pumps extracted prematurely, as well as those that reached the elective replacement interval. The median ITP longevity was 5.9 years (95% confidence interval: [5.6, 6.1]) for pumps explanted for end of battery life. The median system cost per day was $10.46. The median cost per day of pumps explanted for end of battery life was $9.26, versus $44.59 for pumps explanted prematurely due to complications. CONCLUSIONS: Overall, the cohort experienced an increased incidence of pump-related complications and a device longevity that was within the range of the manufacturer's anticipated lifespan. Increasing the lifespan of the ITP and improving patient selection have the potential to significantly improve the cost-effectiveness of intrathecal therapy.