Closing the Chasm: Understanding and Addressing the Anesthesia Workforce Supply and Demand Imbalance.

The imbalance in anesthesia workforce supply and demand has been exacerbated post-COVID due to a surge in demand for anesthesia care, especially in non-operating room anesthetizing sites, at a faster rate than the increase in anesthesia clinicians. The consequences of this imbalance or labor shortage compromise healthcare facilities, adversely affect the cost of care, worsen anesthesia workforce burnout, disrupt procedural and surgical schedules, and threaten academic missions and the ability to educate future anesthesiologists. In developing possible solutions, one must examine emerging trends that are affecting the anesthesia workforce, new technologies that will transform anesthesia care and the workforce, and financial considerations, including governmental payment policies. Possible practice solutions to this imbalance will require both short- and long-term multifactorial approaches that include increasing training positions and retention policies, improving capacity through innovations, leveraging technology, and addressing financial constraints.

Brief Assessment of Patient Phenotype to Explain Variability in Postsurgical Pain and Opioid Consumption after Cesarean Delivery: Performance of a Novel Brief Questionnaire Compared to Long Questionnaires.

BACKGROUND: Understanding factors that explain why some women experience greater postoperative pain and consume more opioids after cesarean delivery is crucial to building an evidence base for personalized prevention. Comprehensive psychosocial assessment with validated questionnaires in the preoperative period can be time-consuming. A three-item questionnaire has shown promise as a simpler tool to be integrated into clinical practice, but its brevity may limit the ability to explain heterogeneity in psychosocial pain modulators among individuals. This study compared the explanatory ability of three models: (1) the 3-item questionnaire, (2) a 58-item questionnaire (long) including validated questionnaires (e.g., Brief Pain Inventory, Patient Reported Outcome Measurement Information System [PROMIS]) plus the 3-item questionnaire, and (3) a novel 19-item questionnaire (brief) assessing several psychosocial factors plus the 3-item questionnaire. Additionally, this study explored the utility of adding a pragmatic quantitative sensory test to models. METHODS: In this prospective, observational study, 545 women undergoing cesarean delivery completed questionnaires presurgery. Pain during local anesthetic skin wheal before spinal placement served as a pragmatic quantitative sensory test. Postoperatively, pain and opioid consumption were assessed. Linear regression analysis assessed model fit and the association of model items with pain and opioid consumption during the 48 h after surgery. RESULTS: A modest amount of variability was explained by each of the three models for postoperative pain and opioid consumption. Both the brief and long questionnaire models performed better than the three-item questionnaire but were themselves statistically indistinguishable. Items that were independently associated with pain and opioid consumption included anticipated postsurgical pain medication requirement, surgical anxiety, poor sleep, pre-existing pain, and catastrophic thinking about pain. The quantitative sensory test was itself independently associated with pain across models but only modestly improved models for postoperative pain. CONCLUSIONS: The brief questionnaire may be more clinically feasible than longer validated questionnaires, while still performing better and integrating a more comprehensive psychosocial assessment than the three-item questionnaire.

Financial Viability of the No Surprises Act Independent Dispute Resolution Process: Radiology and Other Hospital-Based Specialties.

BACKGROUND. The federal No Surprises Act (NSA), designed to eliminate surprise medical billing for out-of-network (OON) care for circumstances beyond patients' control, established the independent dispute resolution (IDR) process to settle clinician-payer payment disputes for OON care. OBJECTIVE. The purpose of our study was to assess the fraction of OON claims for which radiologists and other hospital-based specialists can expect to at least break even when challenging payer-determined payments through the NSA IDR process, as a measure of the process's financial viability. METHODS. This retrospective study extracted claims from a national commercial database (Optum's deidentified Clinformatics Data Mart) for hospital-based specialties occurring on the same day as in-network emergency department (ED) visits or inpatient stays from January 2017 to December 2021. OON claims were identified. OON claims batching was simulated using IDR rules. Maximum potential recovered payments from the IDR process were estimated as the difference between the charges and the allowed amount. The percentages of claims for which the maximum potential payment and one-quarter of this amount (a more realistic payment recovery estimate) would exceed IDR fees were determined, using US$150 and US$450 fee thresholds to approximate the range of final 2024 IDR fees. These values represented the percentage of OON claims that would be financially viable candidates for IDR submission. RESULTS. Among 76,221,264 claims for hospital-based specialties associated with in-network ED visits or inpatient stays, 1,482,973 (1.9%) were OON. The maximum potential payment exceeded fee thresholds of US$150 and US$450 for 55.0% and 32.1%, respectively, of batched OON claims for radiologists and 76.8% and 61.3% of batched OON claims for all other hospital-based specialties combined. At payment of one-quarter of that amount, these values were 26.9% and 10.6%, respectively, for radiologists and 56.6% and 38.4% for all other hospital-based specialties combined. CONCLUSION. The IDR process would be financially unviable for a substantial fraction of OON claims for hospital-based specialists (more so for radiology than for other such specialties). CLINICAL IMPACT. Although the NSA enacted important patient protections, IDR fees limit clinicians' opportunities to dispute payer-determined payments and potentially undermine their bargaining power in contract negotiations. Therefore, IDR rulemaking may negatively impact patient access to in-network care.

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

Procedure-specific acute pain trajectory after elective total hip arthroplasty: systematic review and data synthesis.

BACKGROUND: For most procedures, there is insufficient evidence to guide clinicians in the optimal timing of advanced analgesic methods, which should be based on the expected time course of acute postoperative pain severity and aimed at time points where basic analgesia has proven insufficient. METHODS: We conducted a systematic search of the literature of analgesic trials for total hip arthroplasty (THA), extracting and pooling pain scores across studies, weighted for study size. Patients were grouped according to basic anaesthetic method used (general, spinal), and adjuvant analgesic interventions such as nerve blocks, local infiltration analgesia, and multimodal analgesia. Special consideration was given to high-risk populations such as chronic pain or opioid-dependent patients. RESULTS: We identified and analysed 71 trials with 5973 patients and constructed pain trajectories from the available pain scores. In most patients undergoing THA under general anaesthesia on a basic analgesic regimen, postoperative acute pain recedes to a mild level (<4/10) by 4 h after surgery. We note substantial variability in pain intensity even in patients subjected to similar analgesic regimens. Chronic pain or opioid-dependent patients were most often actively excluded from studies, and never analysed separately. CONCLUSIONS: We have demonstrated that it is feasible to construct procedure-specific pain curves to guide clinicians on the timing of advanced analgesic measures. Acute intense postoperative pain after THA should have resolved by 4-6 h after surgery in most patients. However, there is a substantial gap in knowledge on the management of patients with chronic pain and opioid-dependent patients.

The Use of Contrast Agents in Interventional Pain Procedures: A Multispecialty and Multisociety Practice Advisory on Nephrogenic Systemic Fibrosis, Gadolinium Deposition in the Brain, Encephalopathy After Unintentional Intrathecal Gadolinium Injection, and Hypersensitivity Reactions.

This Practice Advisory presents a comprehensive and evidence-based set of position statements and recommendations for the use of contrast media in interventional pain procedures. The advisory was established by an international panel of experts under the auspices of 11 multinational and multispecialty organizations based on a comprehensive review of the literature up to December 31, 2019. The advisory discusses the risks of using gadolinium-based contrast agents. These include nephrogenic systemic fibrosis, gadolinium brain deposition/retention, and encephalopathy and death after an unintentional intrathecal gadolinium injection. The advisory provides recommendations on the selection of a specific gadolinium-based contrast agent in patients with renal insufficiency, those who had multiple gadolinium-enhanced magnetic resonance imaging examinations, and in cases of paraspinal injections. Additionally, recommendations are made for patients who have a history of mild, moderate, or severe hypersensitivity reactions to contrast medium.

Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain.

OBJECTIVES: The purpose of the ongoing follow-up of ReActiv8-A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four-year outcomes of this trial. MATERIALS AND METHODS: ReActiv8-A is a prospective, single-arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30-min stimulation-sessions twice daily. Annual follow-up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ-5D). Background on mechanisms, trial design, and one-year outcomes were previously described. RESULTS: At baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ-5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. Patients completing year 4 follow-up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ-5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment. CONCLUSIONS: In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality-of-life are clinically meaningful and durable through four years.

First-Year Results of the American Board of Anesthesiology's Objective Structured Clinical Examination for Initial Certification.

In 2018, the American Board of Anesthesiology (ABA) became the first US medical specialty certifying board to incorporate an Objective Structured Clinical Examination (OSCE) into its initial certification examination system. Previously, the ABA's staged examination system consisted of 2 written examinations (the BASIC and ADVANCED examinations) and the Standardized Oral Examination (SOE). The OSCE and the existing SOE are now 2 separate components of the APPLIED Examination. This report presents the results of the first-year OSCE administration. A total of 1410 candidates took both the OSCE and the SOE in 2018. Candidate performance approximated a normal distribution for both the OSCE and the SOE, and was not associated with the timing of the examination, including day of the week, morning versus afternoon session, and order of the OSCE and the SOE. Practice-based Learning and Improvement was the most difficult station, while Application of Ultrasonography was the least difficult. The correlation coefficient between SOE and OSCE scores was 0.35 ([95% confidence interval {CI}, 0.30-0.39]; P < .001). Scores for the written ADVANCED Examination were modestly correlated with scores for the SOE (r = 0.29 [95% CI, 0.25-0.34]; P < .001) and the OSCE (r = 0.15 [95% CI, 0.10-0.20]; P < .001). Most of the candidates who failed the SOE passed the OSCE, and most of the candidates who failed the OSCE passed the SOE. Of the 1410 candidates, 77 (5.5%) failed the OSCE, 155 (11.0%) failed the SOE, and 25 (1.8%) failed both. Thus, 207 (14.7%) failed at least 1 component of the APPLIED Examination. Adding an OSCE to a board certification examination system is feasible. Preliminary evidence indicates that the OSCE measures aspects of candidate abilities distinct from those measured by other examinations used for initial board certification.

The American Board of Anesthesiology's Staged Examination System and Performance on the Written Certification Examination After Residency.

This study compared anesthesiology residency graduates' written certification examination performance before and after the American Board of Anesthesiology (ABA) introduced the staged examination system. After equating test scores using common test items, the first 2 cohorts (2013, 2014) in the staged system scored 7.1 points and 8.3 points higher than the 2011 baseline cohort in the former examination system. The 2013 and 2014 cohorts' pass rates (94.2% and 95.9%) were also higher than the 2011 and 2012 cohorts (91.9% and 92.6%) if a common standard had been applied. The staged examination system may be associated with improved knowledge of anesthesiology graduates.

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

BACKGROUND: Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. METHODS: This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. RESULTS: A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. CONCLUSIONS: Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

The American Board of Anesthesiology's Standardized Oral Examination for Initial Board Certification.

The American Board of Anesthesiology (ABA) has been administering an oral examination as part of its initial certification process since 1939. Among the 24 member boards of the American Board of Medical Specialties, 13 other boards also require passing an oral examination for physicians to become certified in their specialties. However, the methods used to develop, administer, and score these examinations have not been published. The purpose of this report is to describe the history and evolution of the anesthesiology Standardized Oral Examination, its current examination development and administration, the psychometric model and scoring, physician examiner training and auditing, and validity evidence. The many-facet Rasch model is the analytic method used to convert examiner ratings into scaled scores for candidates and takes into account how difficult grader examiners are and the difficulty of the examination tasks. Validity evidence of the oral examination includes that it measures aspects of clinical performance not accounted for by written certifying examinations, and that passing the oral examination is associated with a decreased risk of subsequent license actions against the anesthesiologist. Explaining the details of the Standardized Oral Examination provides transparency about this component of initial certification in anesthesiology.

Safe Use of Epidural Corticosteroid Injections: Recommendations of the WIP Benelux Work Group.

BACKGROUND: Epidural corticosteroid injections are used frequently worldwide in the treatment of radicular pain. Concerns have arisen involving rare major neurologic injuries after this treatment. Recommendations to prevent these complications have been published, but local implementation is not always feasible due to local circumstances, necessitating local recommendations based on literature review. METHODS: A work group of 4 stakeholder pain societies in Belgium, The Netherlands, and Luxembourg (Benelux) has reviewed the literature involving neurological complications after epidural corticosteroid injections and possible safety measures to prevent these major neurologic injuries. RESULTS: Twenty-six considerations and recommendations were selected by the work group. These involve the use of imaging, injection equipment particulate and nonparticulate corticosteroids, epidural approach, and maximal volume to be injected. CONCLUSION: Raising awareness about possible neurological complications and adoption of safety measures recommended by the work group aim at reducing the risks for these devastating events.

Scope and Nature of Pain- and Analgesia-Related Content of the United States Medical Licensing Examination (USMLE).

Background: "The ongoing opioid crisis lies at the intersection of two substantial public health challenges-reducing the burden of suffering from pain and containing the rising toll of the harms that can result from the use of opioid medications" [1]. Improved pain education for health care providers is an essential component of the multidimensional response to both still-unmet challenges [2,3]. Despite the importance of licensing examinations in assuring competency in health care providers, there has been no prior appraisal of pain and related content within the United States Medical Licensing Examination (USMLE). Methods: An expert panel developed a novel methodology for characterizing USMLE questions based on pain core competencies and topical and public health relevance. Results: Under secure conditions, raters used this methodology to score 1,506 questions, with 28.7% (432) identified as including the word "pain." Of these, 232 questions (15.4% of the 1,506 USMLE questions reviewed) were assessed as being fully or partially related to pain, rather than just mentioning pain but not testing knowledge of its mechanisms and their implications for treatment. The large majority of questions related to pain (88%) focused on assessment rather than safe and effective pain management, or the context of pain. Conclusions: This emphasis on assessment misses other important aspects of safe and effective pain management, including those specific to opioid safety. Our findings inform ways to improve the long-term education of our medical and other graduates, thereby improving the health care of the populations they serve.

New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial.

OBJECTIVES: The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS). MATERIALS AND METHODS: Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ≥2-point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ-5D). RESULTS: For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ≥MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ≥MCID improvement in ODI was 52%, 57%, and 60% while those with ≥MCID improvement in EQ-5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach. CONCLUSIONS: Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.