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).

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Multifidus dysfunction and restorative neurostimulation: a scoping review.

OBJECTIVE: Chronic low back pain (CLBP) is multifactorial in nature, with recent research highlighting the role of multifidus dysfunction in a subset of nonspecific CLBP. This review aimed to provide a foundational reference that elucidates the pathophysiological cascade of multifidus dysfunction, how it contrasts with other CLBP etiologies and the role of restorative neurostimulation. METHODS: A scoping review of the literature. RESULTS: In total, 194 articles were included, and findings were presented to highlight emerging principles related to multifidus dysfunction and restorative neurostimulation. Multifidus dysfunction is diagnosed by a history of mechanical, axial, nociceptive CLBP and exam demonstrating functional lumbar instability, which differs from other structural etiologies. Diagnostic images may be used to grade multifidus atrophy and assess other structural pathologies. While various treatments exist for CLBP, restorative neurostimulation distinguishes itself from traditional neurostimulation in a way that treats a different etiology, targets a different anatomical site, and has a distinctive mechanism of action. CONCLUSIONS: Multifidus dysfunction has been proposed to result from loss of neuromuscular control, which may manifest clinically as muscle inhibition resulting in altered movement patterns. Over time, this cycle may result in potential atrophy, degeneration and CLBP. Restorative neurostimulation, a novel implantable neurostimulator system, stimulates the efferent lumbar medial branch nerve to elicit repetitive multifidus contractions. This intervention aims to interrupt the cycle of dysfunction and normalize multifidus activity incrementally, potentially restoring neuromuscular control. Restorative neurostimulation has been shown to reduce pain and disability in CLBP, improve quality of life and reduce health care expenditures.

North American Neuromodulation Society Educational Curriculum for Intrathecal Drug Delivery Systems Implantation and Management.

OBJECTIVES: Intrathecal drug delivery systems (IDDSs) are used for the treatment of pain and spasticity. A wide range of educational criteria exist for these devices. The North American Neuromodulation Society (NANS) Education Committee developed a comprehensive IDDS curriculum to function as a standard for physician graduate education and assessment through training and into practice. MATERIAL AND METHODS: A multidisciplinary and diverse task force gathered by the NANS Education Committee met in person and virtually over several sessions and developed an IDDS curriculum modeling their previous work on spinal cord stimulation and following the Accreditation Council for Graduate Medical Education (ACGME) Milestones. There were iterative revisions and adaptations to the curriculum, and the final version was approved by the NANS Board of Directors. RESULTS: The curriculum was developed with distinction between implanting physicians and managing physician and physicians who perform both tasks. There is a lateral temporal progression from early learner to practitioner, with advanced learner in the middle. In addition, there is a modular vertical organization that divides the curriculum into the six educational competencies outlined by the ACGME. CONCLUSION: A comprehensive, modular, graduated, and segmented educational curriculum for IDDSs was developed by NANS. We propose the curriculum to be the standard for guidance and assessment of trainees and physicians pursuing training in implanting or managing IDDSs.

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.

Pain phenotypes classified by machine learning using electroencephalography features.

Pain is a multidimensional experience mediated by distributed neural networks in the brain. To study this phenomenon, EEGs were collected from 20 subjects with chronic lumbar radiculopathy, 20 age and gender matched healthy subjects, and 17 subjects with chronic lumbar pain scheduled to receive an implanted spinal cord stimulator. Analysis of power spectral density, coherence, and phase-amplitude coupling using conventional statistics showed that there were no significant differences between the radiculopathy and control groups after correcting for multiple comparisons. However, analysis of transient spectral events showed that there were differences between these two groups in terms of the number, power, and frequency-span of events in a low gamma band. Finally, we trained a binary support vector machine to classify radiculopathy versus healthy subjects, as well as a 3-way classifier for subjects in the 3 groups. Both classifiers performed significantly better than chance, indicating that EEG features contain relevant information pertaining to sensory states, and may be used to help distinguish between pain states when other clinical signs are inconclusive.

A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of spinal cord stimulation (SCS) for pain. DESIGN: Grade the evidence for SCS. METHODS: An international, interdisciplinary work group conducted literature searches, reviewed abstracts, and selected studies for grading. Inclusion/exclusion criteria included randomized controlled trials (RCTs) of patients with intractable pain of greater than one year's duration. Full studies were graded by two independent reviewers. Excluded studies were retrospective, had small numbers of subjects, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: SCS has Level 1 evidence (strong) for axial back/lumbar radiculopathy or neuralgia (five high-quality RCTs) and complex regional pain syndrome (one high-quality RCT). CONCLUSIONS: High-level evidence supports SCS for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, SCS was more effective than reoperation or medical management. New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional SCS for patients with axial back pain, with or without radicular pain.

Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER.

OBJECTIVE: The EMP3OWER™ study evaluated spinal cord stimulation (SCS) safety and efficacy and the associated changes in psychosocial and functional outcomes. METHODS: Upon informed consent and IRB approval, 620 eligible subjects were enrolled prior to SCS trial evaluation and were assessed at baseline, 3, 6 and 12 months post-implant. Patient-reported pain relief (PRP), numerical rating scale (NRS), satisfaction, quality of life (QOL), and pain disability index (PDI) were assessed at all follow-up visits while the pain catastrophizing scale (PCS), short form-36 (SF-36), short form-McGill pain questionnaire version 2 (SF-MPQ-2), and the state-trait anxiety inventory (STAI) were assessed at the 6- and 12-month follow-up visits. Device and/or procedure-related adverse events were also recorded and reported. Subjects reporting a PRP ≥ 50% were considered responders. Repeated measures analysis of variance (RMANOVA) examined the changes across time for all continuous measures. RESULTS: A total of 401 (71%) subjects received a permanent implant. Mean (±SD) patient-reported pain relief was 59.3% (±26.2), 59.2% (±28.9), and 58.2% (±32.0) at 3, 6, and 12 months, respectively. A majority of enrolled subjects were responders at 3 (75.5%), 6 (74.7%), and 12 months (69.7%). RMANOVA revealed a statistically significant change for NRS, PCS, PDI, SF-36, SF-MPQ-2, and STAI scores. At 3 months, the majority of subjects (85.7%) were either very satisfied or satisfied with their device, with similar results at 6 and 12 months. At 3 months, the majority of subjects (73.3%) reported greatly improved or improved QOL with similar results at 6 and 12 months. CONCLUSIONS: Spinal cord stimulation provided pain relief and significant improvement of patient psychological and functional outcome measures.

Trends in engagement with cognitive-behavioral therapy for chronic pain conditions after referral.

Cognitive-behavioral therapy for chronic pain (CBT-CP) is an important evidence-based non-pharmacologic treatment for chronic back and neck pain that is frequently recommended as a component of multidisciplinary treatment. However, the success of CBP-CP's implementation in clinical settings is affected by a variety of poorly understood obstacles to patient engagement with CBT-CP. Expanding upon the limited prior research conducted in heterogeneous practice settings, this study examines patterns of treatment initiation for CBT-CP at an interdisciplinary, hospital-based chronic pain practice and conducts exploratory comparisons between groups of patients who did and did not engage in CBT-CP after receiving a referral. Patients' descriptive data, including pain severity, work status, prior therapy, and behavioral health questionnaire scores at intake visit, were obtained through a retrospective chart review of electronic medical records. Data were then analyzed using inter-group comparisons and logistic regression modeling to determine factors that predicted treatment initiation for CBT-CP. On multivariate analysis, we found that patient's depression level as measured by their Patient Health Questionnaire 9 (PHQ-9) score was solely predictive of treatment initiation, as chronic pain patients with a higher level of depression were found to be more likely to attend their recommended appointments of CBT-CP. Anxiety score as measured by GAD-7, work status, pain scores, and prior therapy engagement were not independently predictive. No single "profile" of patient-level factors was found to delineate patients who did and did not initiate CBT-CP, demonstrating the limitations of clinical variables as predictors of uptake.

Cognitive-behavioral therapy (CBT) is a frequently used therapy option, and can be helpful for patients with chronic low back and/or neck pain. However, patients do not always choose to engage in CBT when offered in the context of chronic pain. Reasons patients choose not to pursue CBT, when recommended, are not well understood. This study used data from a hospital-based chronic pain practice in order to identify reasons that patients choose to begin CBT and those who do not. Data about these patients was collected from electronic medical records (EMRs) and was used to conduct statistical analyses, with the goal of determining what factors were significantly different between the two groups of patients. We identified that patients who have more severe depression symptoms based on a specific mental health questionnaire (the Patient Health Questionnaire 9, or PHQ-9) were more likely to engage with CBT. Study results imply that patients without comorbid depression may benefit from additional counseling on the potential benefits of CBT in the management of chronic pain. These results also suggest that reasons other than clinical factors are impacting whether or not patients engage with CBT.

Impact of Sacroiliac Belt Utilization on Balance in Patients with Low Back Pain.

Background: Low back pain (LBP) is a common problem which can affect balance and, in turn, increase fall risk. The aim of this investigation was to evaluate the impact of a Sacroiliac Belt (SB) on balance and stability in patients with LBP. Methods: Subjects with LBP and without LBP ("Asymptomatic") were enrolled. Baseline balance was assessed using the Berg Balance Scale. In a counterbalanced crossover design, LBP and Asymptomatic subjects were randomized to one of two groups: 1) start with wearing the SB (Serola Biomechanics, Inc.) followed by not wearing the SB or 2) start without wearing the SB followed by wearing the SB. For subjects in both groups, dynamic balance was then assessed using the Star Excursion Balance Test (SEBT) with each leg planted. Results: Baseline balance was worse in LBP subjects (Berg 51/56) than Asymptomatic subjects (Berg 56/56) (p<0.01). SB significantly improved SEBT performance in LBP subjects regardless of which leg was planted (p<0.01). SB positively impacted Asymptomatic subjects' SEBT performance with the left leg planted (p=0.0002). Conclusion: The Serola Sacroiliac Belt positively impacted dynamic balance for subjects with low back pain. Further research is needed to examine additional interventions and outcomes related to balance in patients with back pain, and to elucidate the mechanisms behind improvements in balance related to sacroiliac belt utilization.

Comprehensive analysis of trends in Medicare utilization and reimbursement in Physical Medicine & Rehabilitation: 2012 to 2017.

INTRODUCTION: There is an absence of literature describing Medicare utilization by physiatrists, despite their key role in treating Medicare enrollees with qualifying disabilities and common neuromusculoskeletal conditions. OBJECTIVE: To analyze Medicare data regarding physiatrists and their beneficiaries, services, and reimbursement, as well as trends in utilization and geographic distribution. DESIGN AND SETTING: Retrospective analysis of publicly available Centers for Medicare & Medicaid Services data for Medicare beneficiaries receiving physiatric services from 2012 to 2017. MAIN OUTCOME MEASURES: After adjustment for inflation, variables assessed for changes over time included provider and beneficiary demographics, total Medicare reimbursement, and the number of services provided, subsequently separated by drug and medical service metrics. Lorenz curves and Gini coefficients were computed to study reimbursement inequality. Choropleth maps were generated to assess geographic differences in physician density and reimbursement, both by state and ZIP code. RESULTS: The number of physiatrists utilizing Medicare increased from 7230 to 7895 from 2012 to 2017, whereas the average number of unique beneficiaries per clinician remained constant (307 vs. 310; p = .51). The beneficiaries' mean hierarchical conditions category (HCC) health risk score, normalized to 1.0 for the average beneficiary, increased significantly from 2012 to 2017 (1.72 vs. 1.80; p < .01). The mean Medicare reimbursement per physiatrist decreased significantly from 2012 to 2017 ($131,960 vs. $117,623; p < .001), whereas the mean number of services remained constant (3243 vs. 3077; p = .132). Botulinum toxin and baclofen injections were the two most reimbursed drug-related services. Gini coefficients ranged from 0.52 to 0.53 for 2012 to 2017, suggesting moderate reimbursement inequality, with the 75th percentile receiving on average two times the median. Both physician density and top earners were concentrated in urban and metropolitan areas. CONCLUSIONS: Despite rising health care costs and the increasing medical complexity of physiatrists' beneficiaries, Medicare payments have decreased over time. These trends are relevant to both providers and policymakers, particularly in light of unequal geographic distribution of physiatrists across the country.

Use of Accelerometry as an Educational Tool for Spinal Cord Stimulation: A Pilot Study.

Background: Spinal cord stimulation (SCS) is an important option for patients with chronic neuropathic pain. In the United States, a successful SCS trial determines eligibility for SCS implant. Metrics to determine success are often self-reported and subjective, which may limit achievement of patient goals. This study aimed to assess whether patients undergoing SCS implant after successful trial felt that use of external accelerometry prior to implant was a useful educational tool to objectively appraise function and achievement of treatment goals. Methods: This was a single center, prospective, pilot study. Sixteen subjects with persistent spinal pain syndrome type 2 underwent a percutaneous SCS trial. Five subjects did not have a successful trial, one expired after the SCS trial, before implant, and one dropped out prior to completion of post-implant follow-up visits. Nine subjects underwent SCS implant and completed the required follow-up visits. All subjects were provided an Actigraph GT3X external accelerometer, worn 7 days prior to the trial to determine baseline physical activity and during the 7-day trial to assess for change in activity from baseline. Results were shared with subjects to individualize goals for therapy. Goal attainment was assessed at 1, 3, and 6 months after implant. Subjects wore the accelerometer again 24 hours before visits to update progress in meeting treatment goals. The primary outcome was satisfaction with using accelerometry as an educational tool to appraise function and guide treatment goals for SCS therapy. Secondary outcomes included physical activity, as captured via accelerometry, as well as validated patient-reported measures of pain severity, physical functioning, and quality-of-life. Results: Eight of nine subjects were satisfied with accelerometry as an educational tool. Secondary outcomes were not reliably assessed due to poor stewardship and study execution. Conclusion: External accelerometry may assist patients in developing individualized functional treatment goals for SCS therapy.

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain.

Introduction: Painful lumbar spinal disorders represent a leading cause of disability in the US and worldwide. Interventional treatments for lumbar disorders are an effective treatment for the pain and disability from low back pain. Although many established and emerging interventional procedures are currently available, there exists a need for a defined guideline for their appropriateness, effectiveness, and safety. Objective: The ASPN Back Guideline was developed to provide clinicians the most comprehensive review of interventional treatments for lower back disorders. Clinicians should utilize the ASPN Back Guideline to evaluate the quality of the literature, safety, and efficacy of interventional treatments for lower back disorders. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for a comprehensive clinical guideline to provide evidence-based recommendations. Experts from the fields of Anesthesiology, Physiatry, Neurology, Neurosurgery, Radiology, and Pain Psychology developed the ASPN Back Guideline. The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for back-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using United States Preventive Services Task Force (USPSTF) criteria and consensus points are presented. Results: After a comprehensive review and analysis of the available evidence, the ASPN Back Guideline group was able to rate the literature and provide therapy grades to each of the most commonly available interventional treatments for low back pain. Conclusion: The ASPN Back Guideline represents the first comprehensive analysis and grading of the existing and emerging interventional treatments available for low back pain. This will be a living document which will be periodically updated to the current standard of care based on the available evidence within peer-reviewed literature.

Transition from Compounded to Monotherapy Intrathecal Pain Medication Reduces Drug Costs: Retrospective Analysis of Patient Billing Data.

BACKGROUND: Chronic pain accounts for several hundred billion dollars in total treatment costs, and lost productivity annually. Selecting cost-effective pain treatments can reduce the financial burden on both individuals and society. Targeted drug delivery (TDD), whereby medications used to treat pain are delivered directly to the intrathecal space, remains an important treatment modality for chronic pain refractory to oral medication management. These medications can be administered alone (monotherapy), or in conjunction with other medications to give a synergistic affect (compounded therapy). While compounded therapy is often prescribed for pain refractory to both oral management and intrathecal monotherapy, compounded administration has not been approved by the United States Food and Drug Administration (FDA), and is thought to be more expensive. In this study, we hypothesized that TDD delivering monotherapy vs compounded therapy would differ significantly in cost. OBJECTIVES: In 2015, a pharmacy-led initiative resulted in an institution-wide policy requiring that all TDD patients, being treated with compounded therapy, be transitioned to FDA-approved intrathecal monotherapy. The intent of this new policy was to eliminate use of non-FDA approved, "off-label" medications. During this transition, our practice used the opportunity to retrospectively analyze and compare the costs of monotherapy vs compounded therapy. STUDY DESIGN: Billing, drug dosing, and pain data were collected from 01/2015 to 01/2019, and reviewed retrospectively for patients originally on compounded intrathecal medication therapy, and compared before and after transition to monotherapy. SETTING: A multidisciplinary hospital-based spine center within an academic tertiary care facility. METHODS: Electronic medical records from the institutional TDD program were retrospectively reviewed to identify all patients on compounded drug therapy before the transition period (2015-2016). Patients were excluded from the study if they chose to switch their care to another practice rather than transitioning from compounded therapy to monotherapy. Cost per medications refill, cost per year, and reported pain scale before and after the transition were computed, and differences were compared using unpaired t tests. Refill costs of individual drugs were also compared. RESULTS: Of 46 patients originally on compounded therapy, 26 patients met inclusion criteria. The most common pre-transition drugs administered as compounded therapy were bupivacaine (n = 17), morphine (n = 15), and clonidine (n = 14), while hydromorphone (n = 10), baclofen (n = 5), and fentanyl (n = 1) were less common. There was a 51.3% decrease in cost per refill (P = 0.135) and a 50.0% decrease in cost per year (P = 0.283) after transition. Morphine and clonidine were both significantly more expensive than hydromorphone and bupivacaine (P < 0.05). After removing cases in which hydromorphone was the baseline opiate, there was a 64.8% decrease in cost per refill (P = 0.041) and a 66.8% decrease in cost per year (P = 0.190). There was no significant difference in the average reported pain scale across the transition (P = 0.323), suggesting stable pain management efficacy. LIMITATIONS: This retrospective study is limited by its small cohort size and lack of a control group. CONCLUSIONS: Based on single-institutional billing data, transition from compounded therapy to monotherapy TDD resulted in cost savings, dependent on the specific combination of drugs initially used for therapy. A larger multi-institutional study is indicated.

An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.

ABSTRACT: Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.

Readability of Patient Education Materials in Physical Medicine and Rehabilitation (PM&R): A Comparative Cross-Sectional Study.

BACKGROUND: Patients are increasingly using the Internet to access health information. Patient awareness and education are crucial to advancing the field of PM&R, but many U.S. adults have insufficient health literacy skills to read and understand patient education materials (PEM), frequently written at the 10th-15th-grade level. Reading ability is key for health literacy, but no previous research has assessed the readability of PEM provided by professional PM&R societies. OBJECTIVES: Evaluate whether the readability of PM&R PEM meets the NIH-recommended eighth-grade reading level; compare readability of PM&R PEM to two commonly accessed patient resources for sports and rehabilitation medicine topics, handouts from the American Academy of Orthopaedic Surgeons (AAOS) and American Academy of Family Physicians (AAFP), whose readability has been previously analyzed. DESIGN: Cross-sectional study. METHODS: Publicly accessible entries within the patient education section of websites sanctioned by professional PM&R societies, as well as the AAOS and AAFP, were analyzed for readability using two validated and widely used tools, the Flesch-Kincaid Grade Level (FKGL) and Simplified Measure of Gobbledygook (SMOG) formulas. Comparative statistics were performed between the three surveyed specialties. MAIN OUTCOME MEASURES: FKGL and SMOG readability scores, which estimate U.S. grade level, or years of education, needed to comprehend text. RESULTS: A total of 167 online PM&R resources were identified and compared to 94 articles from AAOS and 65 from AAFP. Mean SMOG and FKGL levels exceeded the eighth-grade level for both PM&R (SMOG-9.71, 95% CI 9.42-10.0; FKGL-10.35, 95% CI 9.99-10.7) and AAOS (SMOG-9.15, 95% CI 8.96-9.35; FKGL-9.51, 95% CI 9.29-9.74), whereas AAFP met readability guidelines for both measures (SMOG-7.00, 95% CI 6.74-7.27; FKGL-6.76, 95% CI 6.45-7.07). SMOG and FKGL scores suggested significantly higher reading difficulty for PM&R compared to AAOS (SMOG P = .017; FKGL P = .0001) and AAFP (SMOG P < .0001; FKGL P < .0001). Results indicated that 17% of PM&R resources complied with NIH guidelines, vs 8% for AAOS and 83% for AAFP. CONCLUSIONS: The average readability of PM&R PEM exceeds the NIH-recommended and average U.S. adult eighth-grade reading level. The physiatry community can make its patient materials more comprehensible and accessible for patients by providing resources at a more appropriate reading level.