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Abstract OBJECTIVE: We analyzed the cost-effectiveness and cost–utility of treating failed back–surgery syndrome using spinal cord stimulation (SCS) versus reoperation. MATERIALS AND METHODS A disinterested third party collected charge data for the first 42 patients in a randomized controlled crossover trial. We computed the difference in cost with regard to success (cost–effectiveness) and mean quality–adjusted life years (cost–utility). We analyzed the patient–charge data with respect to intention to treat (costs and outcomes as a randomized group), treated as intended (costs as randomized; crossover failure assigned to a randomized group), and final treatment costs and outcomes. RESULTS: By our mean 3.1–year follow–up, 13 of 21 patients (62%) crossed to reoperation versus 5 of 19 patients (26%) who crossed to SCS (P < 0.025). The mean cost per success was US $117,901 for crossovers to SCS. No crossovers to reoperation achieved success despite a mean per-patient expenditure of US $260,584. The mean per-patient costs were US $31,530 for SCS versus US $38,160 for reoperation (intention to treat), US $48,357 for SCS versus US $105,928 for reoperation (treated as intended), and US $34,371 for SCS versus US $36,341 for reoperation (final treatment). SCS was dominant (more effective and less expensive) in the incremental cost–effectiveness ratios and incremental cost–utility ratios. A bootstrapped simulation for incremental costs and quality–adjusted life years confirmed SCS's dominance, with approximately 72% of the cost results occurring below US policymakers' “maximum willingness to pay” threshold. CONCLUSION: SCS was less expensive and more effective than reoperation in selected failed back–surgery syndrome patients, and should be the initial therapy of choice. SCS is most cost–effective when patients forego repeat operation. Should SCS fail, reoperation is unlikely to succeed.

ABSTRACT OBJECTIVE After randomizing 100 failed back surgery syndrome patients to receive spinal cord stimulation (SCS) plus conventional medical management (CMM) or CMM alone, the results of the 6-month Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation (i.e., PROCESS) showed that SCS offered superior pain relief, health-related quality of life, and functional capacity. Because the rate of crossover favoring SCS beyond 6 months would bias a long-term randomized group comparison, we present all outcomes in patients who continued SCS from randomization to 24 months and, for illustrative purposes, the primary outcome (>50% leg pain relief) per randomization and final treatment. METHODS Patients provided data on pain, quality of life, function, pain medication use, treatment satisfaction, and employment status. Investigators documented adverse events. Data analysis included inferential comparisons and multivariate regression analyses. RESULTS The 42 patients continuing SCS (of 52 randomized to SCS) reported significantly improved leg pain relief (P < 0.0001), quality of life (P ≤ 0.01), and functional capacity (P = 0.0002); and 13 patients (31%) required a device-related surgical revision. At 24 months, of 46 of 52 patients randomized to SCS and 41 of 48 randomized to CMM who were available, the primary outcome was achieved by 17 (37%) randomized to SCS versus 1 (2%) to CMM (P = 0.003) and by 34 (47%) of 72 patients who received SCS as final treatment versus 1 (7%) of 15 for CMM (P = 0.02). CONCLUSION At 24 months of SCS treatment, selected failed back surgery syndrome patients reported sustained pain relief, clinically important improvements in functional capacity and health-related quality of life, and satisfaction with treatment.

Background Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation. Methods Participants who are candidates for a currently approved neurostimulation device were enrolled and screened. Participants who fail a tonic trial evaluation, have significant depressive symptoms, or evidence lack of compliance with study procedures by failing to complete 7 days of a Pain Diary are excluded. Participants receiving a permanent implant are randomized to receive: (1) 12 weeks of tonic followed by 12 weeks of burst stimulation or (2) 12 weeks of burst stimulation followed by 12 weeks of tonic stimulation. Assessments occur at 6, 12, 18, and 24 weeks. After 24 weeks, participants choose their preferred therapy and are assessed every 6 months for up to 2 years. All patients had the device leads inserted at the site of a successful tonic stimulation trial. Assessments include: a Pain Diary using a Visual Analog Scale (VAS) for overall, trunk, and limb pain, the Beck Depression Inventory, the Pain Catastrophizing Scale, the Oswestry Disability Index, paresthesia, satisfaction, and therapy preference. Reported adverse events are collected throughout the study. The primary endpoint is the noninferiority of burst stimulation compared to tonic measured by the within-subject difference in the mean overall VAS score at the end of each 12-week stimulation period. Discussion This trial represents the largest controlled trial of burst stimulation to date, and is expected to yield important information regarding the safety and efficacy of burst stimulation. Trial registration ClinicalTrials.gov, NCT02011893 . Registered on 10 December 2013.

Background Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain. Method/Design Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead (Medtronic Inc., Minneapolis, MN, USA) will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness. Discussion Recruitment began in January 2013 and will continue until 2016. Trial registration Clinicaltrials.gov: NCT01697358 ( http://www.clinicaltrials.gov )

A young patient surviving four years after treatment for primary intracerebral small-cell osteosarcoma is reported. This 16-year-old girl presented with headaches, visual disturbance, and papilledema and was found to have a large, heavily calcified mass in the left parietal lobe. A gross total resection of the tumor was performed and pathologic analysis revealed a small-cell osteosarcoma. Thoracic computerized tomography (CT) scans and a complete bone scan showed no other lesions. The patient received adjuvant chemotherapy and radiotherapy. She continues to do well with no evidence of metastases or local recurrence 4 years after her initial presentation. The clinical, radiographic, surgical, pathologic, and immunohistochemical features of this case, along with therapeutic interventions and outcome, are presented.