Petersen, Erika

Background The efficacy of EVOKE therapy, a closed-loop spinal cord stimulation (SCS) system, has been demonstrated in a double-blinded randomized controlled trial (RCT). RCT evidence, however, may not be generalizable to clinical practice, while limitations of real-world evidence may affect its validity. The aim of this study was to evaluate the effectiveness of EVOKE therapy in routine clinical practice employing a rigorous data collection approach. Methods The ECAP study was a prospective, multicenter, single-arm, pragmatic study that enrolled SCS candidates with chronic, intractable trunk and/or limb pain in 22 US investigational sites. PROMIS-29 questionnaire and objective neurophysiological metrics were collected, and minimal clinically important differences (MCIDs) were used to characterize baseline dysfunction and response to EVOKE therapy both at trial end and maximal analgesic effect post-implant visit. Pre-specified subgroup analyses were conducted based on diagnosis. Results EVOKE therapy observed included a dose ratio of 1.3 and neural dose accuracy of 2.8 μV. Improvements of >1 MCID were observed for all domains and improvements of ≥2 MCIDs were observed for six of the seven domains. Improvements observed at trial end were maintained or improved at post-implant visit, with statistically significant improvement in holistic MCID (MD 0.2, 95% CI 0.1 to 0.4, p=0.004), and a significantly greater proportion of patients considered holistic MCID responders (p=0.047). Subgroup analysis by diagnosis showed similar outcomes. Conclusions EVOKE therapy was associated with clinically meaningful improvements in a real-world chronic pain population across different subgroups and disease pathologies, with effects observed at trial end reproduced at post-implant visit.

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.

This study reports the needs-based development, effectiveness and feasibility of a novel, comprehensive spinal cord stimulation (SCS) digital curriculum designed for pain medicine trainees. The curriculum aims to address the documented systematic variability in SCS education and empower physicians with SCS expertise, which has been linked to utilization patterns and patient outcomes. Following a needs assessment, the authors developed a three-part SCS e-learning video curriculum with baseline and postcourse knowledge tests. Best practices were used for educational video production and test-question development. The study period was from 1 February 2020 to 31 December 2020. A total of 202 US-based pain fellows across two cohorts (early-fellowship and late-fellowship) completed the baseline knowledge assessment, while 122, 96 and 88 participants completed all available post-tests for Part I (Fundamentals), Part II (Cadaver Lab) and Part III (Decision Making, The Literature and Critical Applications), respectively. Both cohorts significantly increased knowledge scores from baseline to immediate post-test in all curriculum parts (p<0.001). The early-fellowship cohort experienced a higher rate of knowledge gain for Parts I and II (p=0.045 and p=0.027, respectively). On average, participants viewed 6.4 out of 9.6 hours (67%) of video content. Self-reported prior SCS experience had low to moderate positive correlations with Part I and Part III pretest scores (r=0.25, p=0.006; r=0.37, p<0.001, respectively). Initial evidence suggests that Pain Rounds provides an innovative and effective solution to the SCS curriculum deficit. A future controlled study should examine this digital curriculum’s long-term impact on SCS practice and treatment outcomes.

OBJECTIVE Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine surgery and are not acceptable candidates for spine surgery. The authors have termed this condition "nonsurgical refractory back pain" (NSRBP) and conducted a multicenter, randomized controlled trial to compare CMM with and without 10-kHz SCS in this population. METHODS Patients with NSRBP, as defined above and with a spine surgeon consultation required for confirmation, were randomized 1:1 to patients undergoing CMM with and without 10-kHz SCS. CMM included nonsurgical treatment for back pain, according to physicians’ best practices and clinical guidelines. Primary and secondary endpoints included the responder rate (≥ 50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (EQ-5D-5L), and change in daily opioid use and were analyzed 3 and 6 months after randomization. The protocol allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. RESULTS In total, 159 patients were randomized; 76 received CMM, and 69 (83.1%) of the 83 patients who were assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received stimulation and 1.3% of those who received CMM were found to be study responders (primary outcome, ≥ 50% pain relief; p < 0.001). There was also a significant difference between the treatment groups in all secondary outcomes at 6 months (p < 0.001). In the 10-kHz SCS arm, outcomes were sustained, including a mean 10-cm visual analog scale score of 2.1 ± 2.3 and 2.1 ± 2.2 and mean ODI score of 24.1 ± 16.1 and 24.0 ± 17.0 at 6 and 12 months, respectively (p = 0.9). In the CMM arm, 74.7% (56/75) of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2% responder rate 6 months postimplantation. Five serious adverse events occurred (procedure-related, of 125 total permanent implants), all of which resolved without sequelae. CONCLUSIONS The study results, which included follow-up over 12 months, provide important insights into the durability of 10-kHz SCS therapy with respect to chronic refractory back pain, physical function, quality of life, and opioid use, informing the current clinical practice for pain management in patients with NSRBP.

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