Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement.

OBJECTIVES: Total knee arthroplasty (TKA) is an effective surgery for end-stage knee osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, but percutaneous peripheral nerve stimulation (PNS) is a promising nonopioid treatment option for chronic, persistent postoperative pain. The objective of the present study was to evaluate the effect of a 60-day percutaneous PNS treatment in a multicenter, randomized, double-blind, placebo-controlled trial for treating persistent postoperative pain after TKA. MATERIALS AND METHODS: Patients with postoperative pain after knee replacement were screened for this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects in both groups underwent ultrasound-guided placement of percutaneous fine-wire coiled leads targeting the femoral and sciatic nerves on the leg with postoperative pain. Leads were indwelling for eight weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ≥50% reduction in average pain relative to baseline during weeks five to eight. Functional outcomes (6-minute walk test; 6MWT and Western Ontario and McMaster Universities Osteoarthritis Index) and quality of life (Patient Global Impression of Change) also were evaluated at end of treatment (EOT). RESULTS: A greater proportion of subjects in the PNS groups (60%; 12/20) than in the placebo (sham) group (24%; 5/21) responded with ≥50% pain relief relative to baseline (p = 0.028) during the primary endpoint (weeks 5-8). Subjects in the PNS group also walked a significantly greater distance at EOT than did those in the placebo (sham) group (6MWT; +47% vs -9% change from baseline; p = 0.048, n = 18 vs n = 20 completed the test, respectively). Prospective follow-up to 12 months is ongoing. CONCLUSIONS: This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.

Impact of psychosocial factors on the success of neuromodulation treatment for patients with persistent pain.

INTRODUCTION: Significant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes would be helpful. With increased focus on the use of patient-reported outcomes to improve care, we aim to evaluate the National Institute of Health Patient Reported Outcome Measurement Information System measures for an association with successful SCS trials in patients with persistent pain. METHODS: Our prospective, observational study enrolled 60 patients with persistent pain who underwent an SCS trial. Patients completed demographic and Patient Reported Outcome Measurement Information System computer adaptive test (PROMIS CAT) assessments to measure self-reported pain interference, depression, anxiety, physical functioning, and sleep disturbance at the time they presented for placement of their trial device. RESULTS: Of the 58 patients who underwent successful electrode placement, 11 had an unsuccessful trial. There were no differences in patient demographics between patients with a successful and an unsuccessful trial. Patients who had a successful SCS trial reported lower pre-trial levels of anxiety, depression, and sleep disturbance and decreased post-trial levels of depression, sleep disturbance, and pain interference. CONCLUSIONS: We found that patients with high levels of depression, anxiety, and sleep disturbance using the PROMIS CAT were predictive of unsuccessful trials. In addition, we found that patients with successful SCS trials reported lower levels of these domains on PROMIS CAT administered at the end of the trial.

Hospital-Wide Adherence to Postsurgical Opioid Prescribing Guidelines: A Retrospective Cohort Study.

INTRODUCTION: Lowering opioid prescription doses and quantity decreases the risk of chronic opioid usage. A tool was inserted into the brief operative note for the surgeon to assess the severity of pain associated with the procedure. We studied surgeon adherence to current opioid-prescribing recommendations. METHODS: Retrospective cohort study with 5486 patients were included in the study population. Each patient's prescription was scored yes or no for adherence on total morphine milligram equivalents (MMEs) and days prescribed with the selection in the brief operative note. The entire study population was tested for an increase from the null-hypothesis "benchmark" value of 75% using a one-sided exact binomial test of a single proportion with P < 0.05. This procedure was repeated for subgroups, with P < 0.01. RESULTS: Adherence to guidelines was higher than the 75% benchmark for "total MMEs prescribed" (79.5%; P < 0.001), but lower for "number of days prescribed" (63.5%; P > 0.999). Surgeries with severe predicted pain showed the highest adherence toward total MMEs prescribed at 87.1%, followed by moderate (80.5%) and mild (74.5%). Severe cases also showed the highest adherence in number of days prescribed (92.4%). Adherence to total MMEs prescribed was highest among attending physicians (88.1%) and lowest among residents/fellows (76.6%). CONCLUSIONS: Adherence to current guidelines was 79.5% for MMEs prescribed but only 63.5% for days prescribed. Compliance with guidelines was better for severe procedures than mild or moderate. Differences were seen across surgical departments. While an improvement from previous reports, further improvement is needed to reduce the number of days of opioids prescribed and increase compliance with recommended guidelines.

Accessibility and Ease of Use in Neuromodulation Devices.

BACKGROUND: The utilization of neuromodulation therapy continues to grow as therapeutic indications expand. These conditions often present with comorbid physical, visual, and auditory impairments. Patients with disabilities in these categories may have difficulty operating their devices. Thus, reviewing the accessibility and inclusive design of neuromodulation devices is imperative to ensure equal access for patients of all ability levels. To date, the literature provides little insight into this topic. MATERIALS AND METHODS: Manufacturers of Food and Drug Administration-approved neuromodulation devices in the United States completed our electronic survey to assess neuromodulation device features, universal/inclusive design guidelines, and methods used to make the device accessible to patients with disabilities. RESULTS: We assessed 11 devices from seven manufacturers. Of those, there were six spinal cord, two peripheral nerve, and three deep brain stimulators. Of all respondents, 91% used universal inclusive design guidelines. Of the studied devices, 91% have an interface that uses visual feedback, and 82% have an interface that uses auditory feedback. All surveyed devices were reported to have an interface that requires physical handling. DISCUSSION: Our study found that most devices incorporate auditory signals, buttons with raised indentations, speech commands, or other useful features to assist those with visual disabilities. Visual interfaces may be sufficient for a patient with hearing impairment to use all the surveyed devices. However, dual sensory impairment presents a significant limitation in all devices surveyed. Furthermore, the biggest barrier to using neuromodulation devices was physical impairment because all surveyed devices require physical handling. CONCLUSIONS: Manufacturers have awareness of universal inclusive design principles. However, our study was unable to find a device that is accessible to all users regardless of ability. As such, it is critical to involve universal design principles to ensure that inclusive devices are available to improve patient adherence, treatment efficacy, and outcomes.

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

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

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.

Implementation and Preliminary Effectiveness of a Multidisciplinary Telemedicine Pilot Initiative for Patients with Chronic Non-Cancer Pain in Rural and Underserved Areas at a Major Academic Medical Center.

Background: Arkansas lacks adequate access to high-quality pain care, as evidenced, in part, by it having the second highest opioid prescribing rate in the United States. To improve access to high-quality treatment of chronic pain, we developed the Arkansas Improving Multidisciplinary Pain Care and Treatment (AR-IMPACT) Telemedicine Clinic, a multidisciplinary and interprofessional team of specialists who provide evidence-based pain management for patients with chronic pain. Methods: We conducted a single-arm pilot trial of the AR-IMPACT Telemedicine Clinic with rural, university-affiliated primary care clinics. We assessed the AR-IMPACT Telemedicine Clinic using an implementation framework and preliminary effectiveness measures. Specifically, we assessed 5 of the 8 implementation outcomes of the framework (ie, penetration, adoption, acceptability, appropriateness, and feasibility) using a mixed methods approach. To evaluate implementation outcomes, we used surveys, interviews, and administrative data. We used electronic health record data to measure preliminary effectiveness (ie, changes in average morphine milligram equivalents per day and pain and depression scores). Results: The AR-IMPACT team saw 23 patients that were referred by 13 primary care physicians from three rural, university-affiliated primary care clinics over one year. Of the 19 patients willing to participate in the pilot study, 12 identified as women, 31.6% identified as Black, and over 50% had less than a bachelor's level education. Patients rated the clinic positively with high overall satisfaction. Referring physicians indicated high levels of appropriateness, acceptability, and feasibility of the program. AR-IMPACT team members identified several barriers and facilitators to the feasibility of implementing the program. No changes in preliminary effectiveness measures were statistically significant. Conclusion: Overall, the AR-IMPACT Telemedicine Clinic obtained moderate penetration and adoption, was highly acceptable to patients, was highly acceptable and appropriate to providers, and was moderately feasible to providers and AR-IMPACT team members.

Consensus Guidelines on Interventional Therapies for Knee Pain (STEP Guidelines) from the American Society of Pain and Neuroscience.

Knee pain is second only to the back as the most commonly reported area of pain in the human body. With an overall prevalence of 46.2%, its impact on disability, lost productivity, and cost on healthcare cannot be overlooked. Due to the pervasiveness of knee pain in the general population, there are no shortages of treatment options available for addressing the symptoms. Ranging from physical therapy and pharmacologic agents to interventional pain procedures to surgical options, practitioners have a wide array of options to choose from - unfortunately, there is no consensus on which treatments are "better" and when they should be offered in comparison to others. While it is generally accepted that less invasive treatments should be offered before more invasive ones, there is a lack of agreement on the order in which the less invasive are to be presented. In an effort to standardize the treatment of this extremely prevalent pathology, the authors present an all-encompassing set of guidelines on the treatment of knee pain based on an extensive literature search and data grading for each of the available alternative that will allow practitioners the ability to compare and contrast each option.

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.

Social Media and Professional Conduct (SMART): Best Practice Guidelines from the American Society of Pain and Neuroscience (ASPN).

Social media has revolutionized internet communication and become ubiquitous in modern life. Though it originated as a medium for friendship, social media has evolved into an ideal venue for professional networking, scientific exchange, and brand building. As such, it is a powerful tool with which interventional pain physicians should become familiar. However, given the permanence and visibility of online posts, it is prudent for interventional pain physicians to utilize social media in a manner that is consistent with the ethical and professionalism standards to which they are held by their patients, employers, peers, and state medical boards. While there are extensive publications of professional codes of conduct by medical societies, there is a paucity of literature regarding social media best practices guidelines. Further, to date there have been no social media best practices recommendations specific to interventional pain medicine physicians. While not exhaustive, the aim of this document is to provide recommendations to pain physicians on how to maintain an effective professional and ethical online presence. Specifically, we provide guidance on online persona and professional image, patient-physician interactions online, patient privacy, industry relations, patient education, and brand building.

Do racial and ethnic disparities lead to the undertreatment of pain? Are there solutions?

PURPOSE OF REVIEW: The current review aims to empower anesthesiologists, specifically pain medicine specialists, to become leaders in ensuring equitable care. RECENT FINDINGS: Disparities in both acute and chronic pain medicine lead to increased morbidity for patients of color. Gaps in care include misdiagnosis or under diagnosis of chronic pain disease states, undertreatment of sickle cell disease and other conditions that are common in minorities, under prescription of opioids, and lack of access to novel opioid sparing treatments. While the causes of these disparities are multifactorial, care team implicit bias and lack of representation are two of the major factors. Solutions are challenging, but the authors suggest an inside out solution. We believe that this practice will have far-reaching downstream effects, including improving diversity in our field and quality of care for our patients. SUMMARY: The current article reviews disparities in both acute and chronic pain treatment for underrepresented racial and ethnic minorities in the United States. The authors examine whether implicit bias and lack of representation are a contributing factor for these disparities. Lastly, we will discuss potential solutions.

Workforce solutions to address health disparities.

PURPOSE OF REVIEW: This review focuses on physician workforce racial & ethnic diversity as a solution to improve perioperative and peripartum health equity. RECENT FINDINGS: Black, Indigenous, and Hispanic physicians remain underrepresented in medicine (URiM) and anesthesiology, and efforts to expand this workforce have had limited impact. Psychological forces, including implicit bias, aversive racism, outgroup bias, racial attention bias, stereotype threat, and imposter syndrome all act to reinforce structural racism and decrease opportunity for advancement. Evidence based solutions are emerging, but require institutional commitment and widespread engagement of the entire medical community. SUMMARY: Academic medicine has recognized the need to diversify the physician workforce for more than 50 years, and yet Black, Indigenous, and Hispanic physicians remain URiM. Foundational assumptions and power structures in medicine limit entry, advancement, and retention of URiM physicians. Solutions require leadership and institutional commitment to change the policies, procedures, priorities, and culture of academic medicine.

Lack of Neuromodulation Knowledge Among Rural Family Medicine Residents: A Call for Implementation Research.

Objective: Spinal cord stimulation is a proven, evidence-based therapy for persistent spinal pain syndrome. While some patients with this disease are managed by chronic pain physicians, many are managed in primary care offices. Despite mounting evidence, dissemination of this research outside of neuromodulation related fields and implementation of this treatment in common practice has not yet occurred. We hypothesize that family medicine residents in rural training programs will have little knowledge of neuromodulation despite it being an evidence-based and common treatment of post-laminectomy syndrome. Materials and Methods: Online surveys were sent to family medicine residents in six rural family medicine training programs at the University of Arkansas for Medical Sciences Regional Programs to characterize knowledge of neuromodulation as a treatment for post-laminectomy syndrome. Results: Forty-one percent of responding rural, Arkansas family medicine residents reported treating post-laminectomy syndrome during their training, yet only 10% have referred a patient for neuromodulation consultation. Residents rated their knowledge of neuromodulation/spinal cord stimulation at 19 on a scale of 0 (no knowledge) to 100 (extensive knowledge). Conclusion: Despite proof that neuromodulation is an evidence-based treatment for post-laminectomy/failed back syndrome, rural family medicine residents have limited knowledge about the therapy and many do not consider a referral for neuromodulation. Further research to ascertain effective implementation strategies to increase the uptake of neuromodulation for patients with post-laminectomy syndrome is desperately needed.

Leveraging the Prescription Drug Monitoring Program to Curb Opioid Prescribing in Arkansas.

Effective means of accurately identifying problematic opioid prescribing are needed. Using an iterative approach with the Arkansas State Medical Board Pain Subcommittee, we modified existing opioid prescriber criteria to create seven metrics to be deployed in Arkansas. These included metrics of dose and days' supply, concomitant use of opioid and benzodiazepines, solid dosage units, and numbers of opioid patients and certain opioid prescriptions. Two of these metrics (average MME daily dose per prescription and total oxycodone 30 mg or hydromorphone prescriptions) were weighted by 2, creating a maximum score of 9 of which each prescriber could receive. Twenty prescribers with a score of 7 or greater were identified and referred to the Arkansas State Medical Board Pain Subcommittee for review and subsequent investigation if deemed necessary. Of those 20 prescribers, four were previously investigated and under disciplinary action, and three were under current investigation for misconduct related to prescribing practices. Five prescribers had new investigations opened due to the findings from the metrics, and disciplinary action was taken. Therefore, 12 of the 20 prescribers referred to the Arkansas State Medical Board were deemed worthy of investigation and disciplinary action. The Arkansas opioid prescriber metrics are able to accurately identify prescribers with potentially problematic opioid prescribing.

Individual and Health Policy Factors Associated With Positive Heroin and Opioid Treatment Response: United States, 2018.

Objectives. To identify client- and state-level factors associated with positive treatment response among heroin and opioid treatment episodes in the United States. Methods. We used national data from 46 states using the Treatment Episode Dataset‒Discharges (2018) to identify heroin and opioid treatment episodes (n = 162 846). We defined positive treatment response as a decrease in use between admission and discharge. We used multivariable regression, stratified by race/ethnicity, to identify demographic, pain-related, and state-level factors associated with positive treatment response. Results. Lower community distress was the strongest predictor of better treatment outcomes across all racial/ethnic groups, particularly among White and American Indian/Alaska Native episodes. A primary opioid of heroin was associated with worse outcomes among White and Hispanic episodes. Legislation limiting opioid dispensing was associated with better outcomes among Hispanic episodes. Buprenorphine availability was strongly associated with better outcomes among Black episodes. Conclusions. State-level variables, particularly community distress, had greater associations with positive treatment outcomes than client-level variables. Public Health Implications. Changes in state-level policies and increased resources directed toward areas of high community distress have the potential to improve opioid use disorder treatment and reduce racial/ethnic disparities in treatment outcomes. (Am J Public Health. 2022;112(S1):S66-S76. https://doi.org/10.2105/AJPH.2021.306503).

Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial.

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.

Federal and Statewide Coverage for Opioid-Sparing Chronic Pain Treatments.

BACKGROUND: With increased hospitalizations and deaths related to opioid use disorder, there is an impetus for federal and private insurance companies to provide coverage for integrative treatments that address pain. The Centers for Disease Control and Prevention (CDC) and the current literature recommend that nonpharmacological and nonopioid treatments must be considered for chronic pain management. The continued examination of potential coverage and cost-effectiveness for opioid-sparing alternatives with proven efficacy is critical for physicians who treat chronic pain. STUDY DESIGN: Qualitative analysis of coverage policies for 10 alternative chronic back pain therapies was completed using the most up-to-date publicly available information from federal and state databases until September 2021. OBJECTIVES: To determine coverage for opioid-sparing treatments for chronic back pain across federal and state healthcare systems. METHODS: We selected the alternative therapies from the National Institute of Health's National Center for Complementary and Integrative Health (NCCIH) (www.nccih.nih.gov). We then collected and analyzed coverage policies for federal and state healthcare plans, including Medicare, Veterans Health Administration (VHA), Indian Health Services (IHS), and Medicaid, by accessing federal databases and state policy databases via the department of health and human services (HHS). RESULTS: The 2 most commonly covered nonpharmacologic therapies for chronic back pain are physical therapy and cognitive behavioral therapy. Other more novel therapies have a heterogenous distribution among federal and state healthcare coverage. Assessment of regional differences determined that the median number of treatments in the Northeast and Midwest was 3, while in the South and West, it was 2. LIMITATIONS: Several provider manuals included varying degrees of information regarding their services. Some states included all pertinent information, such as the definition of treatment, the exact number of service visits allowed annually, and whether prior authorization was necessary. Many manuals provided less information than this. Each state's Medicaid document contained inherent variability, especially with respect to when they were updated or published. Some states had updated information available for 2021, while the most updated policies for other states included documents that were last updated in 2008. CONCLUSIONS: Integrative treatments for chronic back pain are currently available, yet coverage varies widely depending on the patient's Medicare or Medicaid status. Different states cover different therapies, which may lead to unequal healthcare outcomes for patients with chronic pain.