Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions.

Introduction: Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite outcome developed to provide a comprehensive assessment of chronic pain in response to intervention, across 5 outcome domains: pain intensity, health-related quality of life, sleep quality, physical, and emotional function. To focus on domains where the individual need is greatest, the holistic MCID reflects the cumulative MCID averaged over only the domains where subjects were impaired preintervention. Objectives: To assess the internal and construct validity of the Holistic MCID score to inform its future use as an evidence-based tool. Methods: This validation study was undertaken using data from the EVOKE trial with 111 patients up to 24-month follow-up. Internal consistency of the holistic MCID was assessed using Cronbach alpha statistic and dimensional exploration using principal component analysis. Results: The holistic MCID measure demonstrated strong internal consistency with Cronbach alpha >0.7 at all follow-ups. Principal component analysis showed one overarching holistic dimension to be present in the composite. Construct validity was demonstrated by an increase in the holistic MCID score being associated with both increased Patients' Global Impression of Change, EuroQol visual analogue scale score, and each of the outcome domains in a "leave-one-out" analysis (all P < 0.001). Conclusion: The holistic MCID provides a valid measure for the comprehensive, personalized assessment of response after a chronic pain intervention. The validity of the holistic MCID requires further confirmation in other chronic pain populations and with different interventions.

Psilocybin and chronic neuropathic pain: a systematic review.

BACKGROUND/IMPORTANCE: Chronic pain affects many people globally, requiring alternative management strategies. Psilocybin is gaining attention for its potential in chronic pain management despite being classified as Schedule I. OBJECTIVE: This systematic review critically evaluates the evidence for psilocybin, a Schedule I substance, in the treatment of chronic pain. The exact purpose of the review is to assess the impact of psilocybin on chronic pain relief, focusing on dosing protocols, treated conditions, and patient outcomes. EVIDENCE REVIEW: A comprehensive review of PubMed, CINAHL, Web of Science, Cochrane Library, and EMBASE was conducted up to January 2024. Eligibility criteria included studies evaluating psilocybin for chronic pain management. The risk of bias was assessed using the MASTER (MethodologicAl STandards for Epidemiological Research) scale, and the strength of evidence was graded using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). FINDINGS: The review identified 28 relevant studies focusing on dosing, treated conditions, and outcomes. The majority of the included studies (76.2%) were of low or very low quality. Several studies with moderate-to-low-quality evidence utilized a 0.14 mg/kg dosing protocol. The findings suggest promise for the use of psilocybin in chronic pain relief, though the quality of evidence is generally low. CONCLUSIONS: The current research shows potential for psilocybin as a treatment option for chronic pain relief. However, methodological issues and a lack of high-quality evidence underscore the need for further investigations with standardized protocols. Despite these limitations, the potential for psilocybin in chronic pain management is encouraging. PROSPERO REGISTRATION NUMBER: CRD42023493823.

Kratom: a primer for pain physicians.

PURPOSE OF REVIEW: Kratom is used commonly in the United States, usually to mitigate pain, opioid withdrawal, or fatigue. A comprehensive discussion on kratom, tailored to pain management physicians, is needed, given its associated risks and potential interactions. RECENT FINDINGS: Kratom and its main metabolites, mitragynine and 7-OH-mitragynine, bind to a variety of receptors including mu opioid receptors. Still, kratom cannot be described as a classic opioid. Kratom has been utilized without FDA approval as an alternative to traditional medications for opioid use disorder and opioid withdrawal. Lower doses of kratom typically cause opioid-like effects while higher doses can have sedating effects. Tolerance, dependence and withdrawal still occur, although kratom withdrawal appears to be more moderate than opioid withdrawal. Contamination with heavy metals and biological toxins is concerning and there is potential for serious complications, including seizures and death. SUMMARY: The use of kratom as an opioid-sparing alternative as a part of a multimodal pain regimen is not without significant risks. It is of utmost importance for pain physicians to be aware of the risks and adverse effects associated with kratom use.

Shifts in Students' Attitudes Towards Pain Patients, Pain, and Opioid Management Following a Dedicated Medical School Pain Curriculum.

Objective: To examine the immediate effects of a comprehensive pain course on medical students' pre-existing perceptions and attitudes toward pain patients and opioid management. Methods: First-year medical students at a major academic medical center enrolled in a required pre-clerkship pain course in June 2020 and completed pre- and post-course online surveys with Likert-scale questions about their attitudes toward pain management and opioid-related issues. Additionally, the surveys included a free-text question where the students listed the first five words that came to mind when hearing the word "opioids". These words were categorized as "professional" or "lay" words and further as having "positive", "negative", or "neutral" connotations. Data analyses included descriptive statistics, as well as non-parametric and parametric tests. Results: Fifty-four of the 119 students responded to pretest and posttest surveys and were included in paired analyses. There was a significant difference between the number of professional words used before (M=1.21, SD=0.97) and after the course (M=2.40 SD=1.33); t(52)=-6.39, P<0.001. Students also used more lay-positive words after the course (M=0.81, SD=0.63) than they used pre-course (M=0.23, SD=0.43); t(51)=-5.98, P<0.001. Students' post-course responses to several key Likert-scale questions showed significant shifts toward more positive attitudes about caring for patients with pain. For example, students acknowledged greater comfort in providing opioids for chronic pain (P<0.001) where appropriate, and enhanced interest in handling complex pain cases (P<0.001). Conclusion: Results showed that a comprehensive, multi-disciplinary pain course could greatly enhance first-year medical students' attitudes toward pain management, chronic pain patients, and the complex issues surrounding opioids.

Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study.

INTRODUCTION: Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies. METHODS: In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1-S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0-10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. RESULTS: 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001). CONCLUSIONS: In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management. TRIAL REGISTRATION NUMBER: NCT03601949.

Remote Management of Spinal Cord Stimulation Devices for Chronic Pain: Expert Recommendations on Best Practices for Proper Utilization and Future Considerations.

OBJECTIVE: Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming. MATERIALS AND METHODS: A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence. RESULTS: Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies. CONCLUSIONS: Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed.

Needs-based novel digital curriculum for the neuromodulation training deficit: Pain Rounds.

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.

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.

Pain Medicine Fellowship Video Interviews: A COVID-19 Trend or Here to Stay?

BACKGROUND: The COVID-19 pandemic ushered in a shift to a video format for pain medicine fellowship interviews for the 2021-2022 academic year, which represented a major change in the fellowship interview paradigm. OBJECTIVES: Our aim was to assess the experience of a video-only format in place of in-person interviews for Pain Medicine fellowship program directors and applicants after the 2020 fellowship interview season to determine the feasibility for continuation beyond COVID-19 travel restrictions. STUDY DESIGN: Survey via Qualtrics. SETTING: Academic pain medicine programs. METHODS: A consortium of program directors converged to discuss methods for determining the effectiveness and future direction of the video format for pain medicine fellowship interviews. Two surveys were formulated, one targeting pain medicine fellowship program directors and the other for candidates interviewing for the year 2021-2022. RESULTS: For applicants, 55 out of 170 responded for a response rate of 32.3%, and for program directors, 38 out of 95 responded for a response rate of 40%. Of the applicants, 45.7% stated that they would prefer video interviews, whereas 27.3% of program directors preferred video interviews. Savings of time and money were the most common reason for preferring video interviews. LIMITATIONS: The number of pain fellowship applicants invited was limited to those who interviewed at a subset of pain fellowships, which may not have been representative of all pain fellow applicants. CONCLUSIONS: The video format for pain medicine fellowship interviews was viewed positively by both candidates and program directors. We suspect that the video format alone or as a part of a hybrid model will become a routine method for the interview process in the future, given its time and cost benefits.

Waddell (Nonorganic) Signs and Their Association With Interventional Treatment Outcomes for Low Back Pain.

BACKGROUND: The rising use of injections to treat low back pain (LBP) has led to efforts to improve selection. Nonorganic (Waddell) signs have been shown to portend treatment failure for surgery and other therapies but have not been studied for minimally invasive interventions. METHODS: We prospectively evaluated the association between Waddell signs and treatment outcome in 3 cohorts: epidural steroid injections (ESI) for leg pain and sacroiliac joint (SIJ) injections and facet interventions for LBP. Categories of Waddell signs included nonanatomic tenderness, pain during sham stimulation, discrepancy in physical examination, overreaction, and regional disturbances divulging from neuroanatomy. The primary outcome was change in patient-reported "average" numerical rating scale for pain intensity (average NRS-PI), modeled as a function of the number of Waddell signs using simple linear regression. Secondary outcomes included a binary indicator of treatment response. We conducted secondary and sensitivity analyses to account for potential confounders. RESULTS: We enrolled 318 patients: 152 in the ESI cohort, 102 in the facet cohort, and 64 in the SIJ cohort, having sufficient data for primary analysis on 308 patients. Among these, 62% (n = 192) had no Waddell signs, 18% (n = 54) had 1 sign, 11% (n = 33) had 2, 5% (n = 16) had 3, 2% (n = 7) had 4, and about 2% (n = 6) had all 5 signs. The mean change in average NRS-PI in each of these 6 groups was -1.6 ± 2.6, -1.1 ± 2.7, -1.5 ± 2.5, -1.6 ± 2.6, -1 ± 1.5, and 0.7 ± 2.1, respectively, and their corresponding treatment failure rates were 54% (102 of 192), 67% (36 of 54), 70% (23 of 33), 75% (12 of 16), 71% (5 of 7), and 83% (5 of 6). In the primary analysis, an increasing number of Waddell signs were not associated with a significant decrease in average NRS-PI (coefficient [Coef] = 0.19; 95% confidence interval [CI], -0.43 to 0.05; P = .12). A higher number of Waddell signs were associated with treatment failure, with a 1.35 increased odds of treatment failure per cumulative number of signs (P = .008). CONCLUSIONS: Whereas this study found no consistent relationship between Waddell signs and decreased mean pain scores, a significant relationship between the number of Waddell signs and treatment failure was observed.

Changes in Pain Medicine Training Programs Associated With COVID-19: Survey Results.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is a public health crisis of unprecedented proportions that has altered the practice of medicine. The pandemic has required pain clinics to transition from in-person visits to telemedicine, postpone procedures, and cancel face-to-face educational sessions. There are no data on how fellowship programs have adapted. METHODS: A 17-question survey was developed covering topics including changes in education, clinical care, and psychological stress due to the COVID pandemic. The initial survey was hosted by Qualtrics Inc and disseminated by the Association of Pain Program Directors on April 10, 2020, to program directors at Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowships. Results are reported descriptively and stratified by COVID infection rate, which was calculated from Centers for Disease Control and Prevention data on state infections, and census data. RESULTS: Among 107 surveys distributed, 70 (65%) programs responded. Twenty-nine programs were located in states in the upper tertile for per capita infection rates, 17 in the middle third, and 23 in the lowest tertile. Nearly all programs (93%) reported a decreased workload, with 11 (16%) reporting a dramatic decrease (only urgent or emergent cases). Just more than half of programs had either already deployed (14%) or credentialed (39%) fellows to provide nonpain care. Higher state infection rates were significantly associated with reduced clinical demand (Rs = 0.31, 95% confidence interval [CI], 0.08-0.51; P = .011) and redeployment of fellows to nonpain areas (Rs = 0.30, 95% CI, 0.07-0.50; P = .013). Larger program size but not infection rate was associated with increased perceived anxiety level of trainees. CONCLUSIONS: We found a shift to online alternatives for clinical care and education, with correlations between per capita infection rates, and clinical care demands and redeployment, but not with overall trainee anxiety levels. It is likely that medicine in general, and pain medicine in particular, will change after COVID-19, with greater emphasis on telemedicine, virtual education, and greater national and international cooperation. Physicians should be prepared for these changes.

Prognostic value of hypersensitivity reactions on epidural steroid injection outcomes: a phenotypic signature? A prospective cohort study.

BACKGROUND: Studies have found that diffuse pain, indicative of central sensitization, portends poor interventional outcomes. Multiple chemical sensitivities are associated with signs of central sensitization. We sought to prospectively determine whether hypersensitivity reactions (HR) were associated with epidural steroid injection (ESI) outcomes. METHODS: HR were classified as immune-related or non-immune-related and categorized by number (0=low, 1 or 2=intermediate, ≥3=high). The primary outcome measure was mean reduction in average leg pain score 1 month post-procedure. A positive outcome was defined as a two-point or greater decrease in average leg pain accompanied by satisfaction 1 month post-procedure. RESULTS: The mean number of immune-mediated and non-immune-mediated HR were 0.6±1.2 and 0.8±1.4, respectively. Individuals in the high (n=24) total HR group had a mean reduction in average leg pain of 0.1±2.7, compared with those in the low (n=61; 1.8±2.1, p=0.025) and intermediate groups (n=52; 1.6±3.1, p=0.060). For back pain and categorical successful outcome, those with fewer HR experienced greater benefit. There were no differences in outcomes when patients were stratified by immune-related HR. Among participants in the low, intermediate and high non-immune-mediated HR groups, the mean reductions in average leg pain scores were 1.7±2.5, 1.6±3.0, and -0.2±2.3, respectively (p = 0.002). 51%, 35%, and 12% of people with low, intermediate and high numbers of non-immune-mediated HR experienced a positive categorical outcome, respectively (p=0.007). CONCLUSIONS: Non-immune-related HR were inversely correlated with some ESI outcome measures.

Gadolinium use for interventional pain procedures: where we are and where we are heading.

In recent years as the use of interventional pain procedures has soared, so too has outside and internal scrutiny. This scrutiny includes agreater emphasis on weighing the risks and benefits of procedures, increased surveillance for adverse events, and cost containment strategies. In 2016, the first reports of gadolinium deposition in the central nervous system began to surface, though retention in other organ systems has been appreciated for over a decade. In this issue of Regional Anesthesia & Pain Medicine, Benzon et al. report a series of patients with document edhypersensitivity reactions to iodinated contrast medium who were inadvertently administered iodine-based contrast without adverse consequences. In this article, we discuss the epidemiology of contrast-mediated adverse effects, the mechanistic basis for hypersensitivity reactions, the risks and benefits of various approaches in the patient with a documented contrast hypersensitivity reaction, and risk mitigation strategies.