Effect of Spinal Cord Stimulation on Early Disability Pension in 198 Failed Back Surgery Syndrome Patients: Case-Control Study.

BACKGROUND: Spinal cord stimulation (SCS) has proven to be a cost-effective treatment for failed back surgery syndrome (FBSS). However, the effect on patients' working capability remains unclear. OBJECTIVE: To evaluate the impact of SCS on working capability and to identify the factors behind permanent disability in FBSS patients. METHODS: The study group consisted of 198 working-age patients with SCS trialed or implanted for FBSS in a single center between 1996 and 2014. For each patient, 3 living controls, matched by age, gender, and birthplace, were otherwise randomly selected by the Population Register Center. The data on working ability were obtained from the Social Insurance Institution. Patients were divided into 3 groups: SCS trial only, SCS implanted permanently, and SCS implanted but later explanted. RESULTS: A rehabilitation subsidy was given to 68 patients and 8 controls for a mean of 5.2 (95% confidence interval [CI] 2.4-8.2) and 0.2 (95% CI 0.05-0.6) days per month (P < .05). At the end of follow-up, 16 (37%), 13 (33%), 25 (22%), and 27 (5%) subjects were on disability pension (DP) in the SCS trial, SCS explanted, SCS permanent, and control groups. Patients in the SCS trial-only group were significantly more often on DP than were patients with permanent SCS (odds ratio 2.6; 95% CI 1.2-5.9; P = .02). CONCLUSION: Permanent SCS usage was associated with reduced sick leave and DP. Prospective study will be required to assess possible predictive value.

Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome.

BACKGROUND: Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US. SCS has been shown to have superior outcomes to CMM or repeat spinal operation in several landmark studies, yet there are few large studies examining its long-term economic impact. OBJECTIVES: This study compares health care utilization for SCS compared to other management in patients with FBSS. STUDY DESIGN: Retrospective. SETTING: Inpatient and outpatient sample. METHODS: Patients with a history of FBSS from 2000 to 2012 were selected. We compared those who received SCS to those who underwent conventional management. A longitudinal analysis was used to model the value of log(cost) in each one year interval using a generalized estimating equations (GEE) model to account for the correlation of the same patient's cost in multiple years. Similarly, a Poisson GEE model with the log link was applied to correlated count outcomes. RESULTS: We identified 122,827 FBSS patients. Of these, 5,328 underwent SCS implantation (4.34%) and 117,499 underwent conventional management. Total annual costs decreased over time following implantation of the SCS system, with follow-up analysis at 1, 3, 6, and 9 years. The longitudinal GEE model demonstrated that placement of an SCS system was associated with an initial increase in total costs at the time of implantation (cost ratio [CR]: 1.74; 95% confidence interval [CI]: 1.41, 2.15, P < 0.001), however there was a significant and sustained 68% decrease in cost in the year following SCS placement (CR: 0.32; 95% CI: 0.24, 0.42, P < 0.001) compared to CMM. There was also an aggregate time trend that for each additional year after SCS, cost decreased on average 40% percent annually (CR: 0.60; 95% CI: 0.55, 0.65, P < 0.001), with follow-up up to 1, 3, 6, and 9 years post-procedure. LIMITATIONS: Costs are not correlated with patient outcomes, patients are not stratified in terms of complexity of prior back surgery, as well as inherent limitations of a retrospective analysis. CONCLUSIONS: We found that from 2000 to 2012, only 4.3% of patients across the United States with FBSS were treated with SCS. Long-term total annual costs for these patients were significantly reduced compared to patients with conventional management. Although implantation of an SCS system results in a short-term increase in costs at one year, the subsequent annual cumulative costs were significantly decreased long-term in the following 9 years after implantation. This study combines the largest group of FBSS patients studied to date along with the longest follow-up interval ever analyzed. Since SCS has repeatedly been shown to have superior efficacy to CMM in randomized clinical trials, the current study demonstrating improved long-term health economics at 1, 3, 6, and 9 years supports the long-term cost utility of SCS in the treatment of FBSS patients. Key words: Failed back surgery syndrome, spinal cord stimulation, back pain, leg pain, neuromodulation, FBSS, SCS.

Multicenter Retrospective Study of Neurostimulation With Exit of Therapy by Explant.

INTRODUCTION: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted. METHODS: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years. RESULTS: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40). DISCUSSION: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal. CONCLUSIONS: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.

Impact of Insurance Provider on Overall Costs in Failed Back Surgery Syndrome: A Cost Study of 122,827 Patients.

OBJECTIVES: Failed back surgery syndrome (FBSS) affects 40% of patients following spine surgery with estimated costs of $20 billion to the US health care system. The aim of this study was to assess the cost differences across the different insurance providers for FBSS patients. METHODS: A retrospective longitudinal study was performed using the Truven MarketScan® database to identify FBSS patients from 2001 to 2012. Patients were grouped into Commercial, Medicaid, or Medicare cohorts. We collected one-year prior to FBSS diagnosis (baseline), then at year of spinal cord stimulation (SCS)-implantation and nine-year post-SCS implantation cost outcomes. RESULTS: We identified 122,827 FBSS patients, with 117,499 patients who did not undergo an SCS-implantation (Commercial: n = 49,075, Medicaid: n = 23,180, Medicare: n = 45,244) and 5328 who did undergo an SCS implantation (Commercial: n = 2279, Medicaid: n = 1003, Medicare: n = 2046). Baseline characteristics were similar between the cohorts, with the Medicare-cohort being significantly older. Over the study period, there were significant differences in overall cost metrics between the cohorts who did not undergo SCS implantation with the Medicaid-cohort had the lowest annual median (interquartile range) total cost (Medicaid: $4530.4 [$1440.6, $11,973.5], Medicare: $7292.0 [$3371.4, $13,989.4], Commercial: $4944.3 [$363.8, $13,294.0], p < 0.0001). However, when comparing the patients who underwent SCS implantation, the commercial-cohort had the lowest annual median (interquartile range) total costs (Medicaid: $4045.6 [$1146.9, $11,533.9], Medicare: $7158.1 [$3160.4, $13,916.6], Commercial: $2098.1 [$0.0, $8919.6], p < 0.0001). CONCLUSIONS: Our study demonstrates a significant difference in overall costs between various insurance providers in the management of FBSS, with Medicaid-insured patients having lower overall costs compared to Commercial- and Medicare-patients. SCS is cost-effective across all insurance groups (Commercial > Medicaid > Medicare) beginning at two years and continuing through nine-year follow-up. Further studies are necessary to understand the cost differences between these insurance providers, in hopes of reducing unnecessary health care expenditures for patients with FBSS.

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

BACKGROUND: Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. MATERIALS AND METHODS: FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. TRIAL STATUS: Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015. TRIAL REGISTRATION: Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237.

Neurostimulation options for failed back surgery syndrome: The need for rational and objective measurements. Proposal of an international clinical network using an integrated database and health economic analysis: the PROBACK network.

INTRODUCTION: In the context of failed back surgery syndrome (FBSS) treatment, the current practice in neurostimulation varies from center-to-center and most clinical decisions are based on an individual diagnosis. Neurostimulation evaluation tools and pain relief assessment are of major concern, as they now constitute one of the main biases of clinical trials. Moreover, the proliferation of technological devices, in a fertile and unsatisfied market, fosters and only furthers the confusion. There are three options available to apply scientific debates to our daily neurostimulation practice: intentional ignorance, standardized evidence-based practice or alternative data mining approach. OBJECTIVE: In view of the impossibility of conducting multiple randomized clinical trials comparing various devices, one by one, the proposed concept would be to redefine the indications and the respective roles of the various spinal cord and peripheral nerve stimulation devices with large-scale computational modeling/data mining approach, by conducting a multicenter prospective database registry, supported by a clinician's global network called "PROBACK". METHODS: We chose to specifically analyze 6 parameters: device coverage performance/coverage selectivity/persistence of the long-term electrical response (technical criteria) and comparative mapping of patient pain relief/persistence of the long-term clinical response/safety and complications occurrence (clinical criteria). Two types of analysis will be performed: immediate analysis (including cost analysis) and computational analysis, i.e. demonstration of the robustness of certain correlations of variables, in order to extract response predictors. DISCUSSION/CONCLUSION: By creating an international prospective database, the purpose of the PROBACK project was to set up a process of extraction and comparative analysis of data derived from the selection, implantation and follow-up of FBSS patients candidates for implanted neurostimulation. This evaluation strategy should help to change the opinions of each implanter and each health system towards a more rational decision-making approach subtended by mathematical reality.

A review of economic factors related to the delivery of health care for chronic low back pain.

INTRODUCTION AND METHODS: We describe tools used to evaluate the economic impact of health care interventions, discuss the economic burden of chronic low back pain, and review evidence on the cost-effectiveness of treating failed back surgery syndrome with spinal cord stimulation, intrathecal drug delivery, acupuncture, epidural injections, disc prosthesis, lumbar fusion, and noninvasive therapies. We also mention the lack of cost studies for emerging therapies, such as vibrotherapy and peripheral nerve field stimulation. Topics include types of cost studies; the economic perspectives taken by such studies; direct and indirect costs; measures of success; definitions of cost-effectiveness, incremental cost-effectiveness, incremental cost-utility ratios, and quality-adjusted life years; the concept of maximum willingness to pay; and the use of cost-effectiveness models. CONCLUSION: The fact that chronic low back pain arises from a variety of causes makes choosing appropriate treatment difficult. Determining the cost-effectiveness of various treatments for chronic low back pain depends on well-designed and well-executed randomized controlled trials with parallel economic evaluations. Researchers can use economic models to extrapolate costs and outcomes over the long term.

Cost effectiveness of a novel 10 kHz high-frequency spinal cord stimulation system in patients with failed back surgery syndrome (FBSS).

OBJECTIVES: Spinal cord stimulation (SCS) is an effective method of relieving chronic intractable pain, and one of its key indications is failed back surgery syndrome (FBSS). The objective of the current study was to evaluate the cost effectiveness of 10 kHz high-frequency SCS (HF10 SCS) compared to conventional medical management (CMM), reoperation, and traditional nonrechargeable (TNR-SCS) and rechargeable SCS (TR-SCS). METHODS: A health economic model of SCS in the United Kingdom was reproduced in the perspective of the health care system to simulate costs and quality adjusted life years (QALYs) over 15 years. In the model, both a decision tree and the Markov model were used to describe the health outcomes of the evaluated therapies. RESULTS: HF10 SCS therapy showed a favorable incremental cost-effectiveness ratio (ICER) of £3,153 per QALY gained as compared to CMM and established dominance (less costly, more QALYs) compared to TNR-SCS (£8,802 per QALY vs. CMM) and TR-SCS (£5,101 per QALY vs. CMM). CONCLUSION: This first analysis of the cost effectiveness of HF10 SCS suggests that it is more cost effective and provides a greater number of QALYs than both TNR-SCS and TR-SCS.

Utilization of spinal cord stimulation in patients with failed back surgery syndrome.

STUDY DESIGN: Retrospective analysis of a population-based insurance claims data set. OBJECTIVE: To evaluate the use of spinal cord stimulation (SCS) and lumbar reoperation for the treatment of failed back surgery syndrome (FBSS), and examine their associated complications and health care costs. SUMMARY OF BACKGROUND DATA: FBSS is a major source of chronic neuropathic pain and affects up to 40% of patients who undergo lumbosacral spine surgery for back pain. Thus far, few economic analyses have been performed comparing the various treatments for FBSS, with these studies involving small sample sizes. In addition, the nationwide practices in the use of SCS for FBSS are unknown. METHODS: The MarketScan data set was used to analyze patients with FBSS who underwent SCS or spinal reoperation between 2000 and 2009. Propensity score methods were used to match patients who underwent SCS with those who underwent lumbar reoperation to examine health care resource utilization. Postoperative complications were analyzed with multivariate logistic regression. Health care use was analyzed using negative binomial and general linear models. RESULTS: The study cohort included 16,455 patients with FBSS, with 395 undergoing SCS implantation (2.4%). Complication rates at 90 days were significantly lower for SCS than spinal reoperation (P < 0.0001). Also in the matched cohort, hospital stay (P < 0.0001) and associated charges (P = 0.016) were lower for patients with SCS. However outpatient, emergency room, and medication charges were similar between the 2 groups. Overall cost totaling $82,586 at 2 years was slightly higher in the lumbar reoperation group than in the SCS group with total cost of $80,669 (P = 0.88). CONCLUSION: Although previous studies have demonstrated superior efficacy for the treatment of FBSS, SCS remains underused. Despite no significant decreases in overall health care cost with SCS implantation, because it is associated with decreased complications and improved outcomes, this technology warrants closer consideration for the management of chronic pain in patients with FBSS.

Rehabilitation perspectives of neuromodulation.

Chronic pain is one of the most prevalent and costly health care problems in the United States today. Two conditions, failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS), in particular have been difficult to manage, resulting in increased disability and poorer quality of life measures for patients as well as increased treatments cost for payers. Given the cost of chronic pain management and overall subjectivity of analog pain scores, many payers are emphasizing the importance of functional outcomes as a means of assessing efficacy of treatment. Neuromodulation devices such as spinal cord stimulators are shown to be cost effective and able to improve functional outcomes and quality of life. Specific rehabilitation therapies also demonstrate improved functional outcomes. This article aims to discuss the role of rehabilitation in the patient with a neuromodulatory device. From the available data and our clinical experience, we recommend incorporating rehabilitation after placement of a neuromodulation device in order to optimize functional outcomes.

Spinal cord stimulation: a review.

Spinal cord stimulation (SCS) is a safe and effective treatment of a variety of chronic pain conditions. As our understanding of the mechanisms of action and potential uses of SCS has evolved, clinical and technological advancements have followed. This review provides an overview of potential mechanisms of action of SCS, evidence for its effectiveness, potential complications, and highlights of developing areas of interest.

Cost per quality-adjusted life year gained of laminectomy and extension of instrumented fusion for adjacent-segment disease: defining the value of surgical intervention.

OBJECT: Over the past decade, there has been a dramatic increase in the number of spinal fusions performed in the US and a corresponding increase in the incidence of adjacent-segment disease (ASD). Surgical management of symptomatic ASD consists of decompression of neural elements and extension of fusion. It has been shown to have favorable long-term outcomes, but the cost-effectiveness remains unclear. In this study, the authors set out to assess the cost-effectiveness of revision surgery in the treatment of ASD over a 2-year period. METHODS: Fifty patients undergoing neural decompression and extension of fusion construct for ASD-associated back and leg pain were included in the study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (± SD) interval between prior fusion and revision surgery for ASD was 3.07 ± 2.02 years. A mean cumulative 2-year gain of 0.76 QALYs was observed after revision surgery. The mean total 2-year cost of extension of fusion constructs was $47,846 ± $32,712 (surgery cost: $24,063 ± $300; outpatient resource utilization cost: $4175 ± $3368; indirect cost: $19,607 ± $32,187). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $62,955. CONCLUSIONS: In the authors' practice, revision decompression and extension of fusion provided a significant gain in health state utility for patients with symptomatic ASD, with a 2-year cost per QALY gained of $62,995. When indicated, revision surgery for ASD is a valuable treatment option for patients experiencing back and leg pain secondary to ASD. The findings provide a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Failed back surgery syndrome.

BACKGROUND: Failed back surgery syndrome (FBSS) is a chronic pain condition that has considerable impact on the patient and health care system. Despite advances in surgical technology, the rates of failed back surgery have not declined. The factors contributing to the development of this entity may occur in the preoperative, intraoperative, and postoperative periods. Due to the severe pain and disability this syndrome may cause, more radical treatments have been utilized. Recent trials have been published that evaluate the efficacy and cost-effectiveness of therapeutic modalities such as spinal cord stimulation for the management of patients with failed back surgery. REVIEW SUMMARY: This article will describe the epidemiology and etiology of FBSS. The importance of prevention will be emphasized. In those patients with established FBSS, a guide to interdisciplinary evaluation and management will be outlined. Special attention will focus on recent trials that have studied the efficacy of more invasive procedures such as spinal cord stimulation. Finally, a suggested management pathway is presented. CONCLUSION: FBSS is a challenging clinical entity with significant impact on the individual and society. To better prevent and manage this condition, knowledge of the factors contributing to its development is necessary. While research on FBSS has increased in recent years, perhaps the best strategy to reduce incidence and morbidity is to focus on prevention. Patients diagnosed with FBSS should be managed in an interdisciplinary environment. More radical treatments for FBSS have now been extensively studied providing clinicians with much needed evidence on their efficacy. Incorporating these results into our current knowledge provides a basis on which to construct an evidence-based guide on how best to manage patients who suffer from FBSS.

Counting the costs: case management implications of spinal cord stimulation treatment for failed back surgery syndrome.

PURPOSE/OBJECTIVES: The purpose of this article is to review clinical and health economic evidence supporting the use of spinal cord stimulation (SCS) for failed back surgery syndrome (FBSS) and to discuss implications for case managers' decision making. PRIMARY PRACTICE SETTINGS: Primary settings include hospital and home environments. FINDINGS/CONCLUSIONS: Patients with FBSS experience persistent or recurring pain in the lower back, legs, or both after one or more spinal surgeries. Surgical revision and nonsurgical FBSS therapies often result in minimal or no clinical improvement, and reoperations often result in more pain. The efficacy and safety of SCS have improved as a result of earlier intervention, technological advances, and increased awareness of SCS proper patient selection. A recent randomized controlled trial (RCT) demonstrated that at mean 3-year follow-up, SCS achieves significantly more pain relief and treatment satisfaction and lower opiate analgesic use than reoperation in patients with FBSS. Another RCT demonstrated that at 6-month follow-up, more patients with FBSS achieve pain relief, enhanced quality of life, improved functioning, and higher treatment satisfaction levels with SCS than with conventional medical management (CMM). Health-economic FBSS studies show that SCS is more cost-effective than CMM or reoperation. SCS is a well-established FBSS treatment option with demonstrated efficacy and cost-effectiveness in selected patients. IMPLICATIONS FOR CM PRACTICE: Case Managers should consider recommending SCS as one modality prior to reoperation in patients with FBSS who meet the clinical criteria for its appropriate use.

Spinal cord stimulation for failed back surgery syndrome: outcomes in a workers' compensation setting.

Questions remain concerning effectiveness and risks of spinal cord stimulation (SCS) for chronic back and leg pain after spine surgery ("failed back surgery syndrome" [FBSS]). This prospective, population-based controlled cohort study evaluated outcomes of workers' compensation recipients with FBSS who received at least a trial of SCS (SCS group, n=51) versus those who (1) were evaluated at a multidisciplinary pain clinic and did not receive SCS (Pain Clinic, n=39) or (2) received neither SCS nor pain clinic evaluation (Usual Care, n=68). Patients completed measures of pain, function, medication use, and work status at baseline and 6, 12, and 24 months later. We also examined work time loss compensation over 24 months. Few (<10%) patients in any group achieved success at any follow-up on the composite primary outcome encompassing less than daily opioid use and improvement in leg pain and function. At 6 months, the SCS group showed modestly greater improvement in leg pain and function, but with higher rates of daily opioid use. These differences disappeared by 12 months. Patients who received a permanent spinal cord stimulator did not differ from patients who received some pain clinic treatment on the primary outcome at any follow-up (<10% successful in each group at each follow-up) and 19% had them removed within 18 months. Both trial and permanent SCS were associated with adverse events. In sum, we found no evidence for greater effectiveness of SCS versus alternative treatments in this patient population after 6 months.