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High-frequency 10?kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.

ABSTRACT: OBJECTIVES:There is good evidence that spinal cord stimulation (SCS) is effective for reducing chronic back and leg pain (CBLP). SENZA randomized controlled trial showed high-frequency (10?kHz) stimulation (10?kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10?kHz-SCS compared with LF-SCS. METHODS:A probabilistic decision tree and Markov decision analytic model was used to synthesize data on CBLP outcomes and costs over a 15-year time horizon from a UK National Health Service perspective using data from the SENZA randomized controlled trial and other publications. Results are expressed as incremental cost per quality-adjusted life year (QALY) in 2016 Pounds Sterling. RESULTS:10?kHz-SCS is cost-saving and cost-effective compared with LF-SCS, with mean cost-savings of £7170 (95% confidence interval: £6767-£7573) and £3552 (95% confidence interval: £3313-£3792) per patient compared with nonrechargeable and rechargeable LF-SCS devices, respectively. 10?kHz-SCS has a 95% likelihood of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. Our findings were robust across a wide range of sensitivity analyses. CONCLUSIONS:There is a strong economic case for choosing 10?kHz-SCS over LF-SCS for CBLP. Furthermore, 10?kHz-SCS has clinical advantages not captured in our analysis, including shorter, and more predictable procedure times.

SUBMITTER: Taylor RS

PROVIDER: S-EPMC7671822 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.

Taylor Rod S RS Bentley Anthony A Campbell Bruce B Murphy Kieran K

The Clinical journal of pain 20201101 11

<h4>Objectives</h4>There is good evidence that spinal cord stimulation (SCS) is effective for reducing chronic back and leg pain (CBLP). SENZA randomized controlled trial showed high-frequency (10 kHz) stimulation (10 kHz-SCS) is clinically superior to traditional low-frequency SCS (LF-SCS).Undertake cost-consequence and cost-effectiveness analysis of 10 kHz-SCS compared with LF-SCS.<h4>Methods</h4>A probabilistic decision tree and Markov decision analytic model was used to synthesize data on CB ...[more]

PMID: 32769414

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Project description:BACKGROUND:Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy. OBJECTIVE:To compare long-term results of HF10 therapy and traditional low-frequency SCS. METHODS:A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ?5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ?50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority. RESULTS:In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < .001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P < .001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P < .001 for non-inferiority and P = .003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P < .001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P < .001 for non-inferiority and P = .002 for superiority). CONCLUSION:This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially. ABBREVIATIONS:IPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale.

Project description:INTRODUCTION:Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10?kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10?kHz SCS for this population. METHODS:This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10?kHz SCS plus usual care (intervention group) or to sham 10?kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5?L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1?month, 3?months and 6?months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient. DISCUSSION:The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10?kHz SCS for use in patients with CNLBP who have not had surgery. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018. DISCLAIMER:The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication. ROLES AND RESPONSIBILITIES:AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.

Project description:ImportanceMany patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.ObjectiveTo determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).Design, setting, and participantsThe prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.InterventionsImplanted medical device delivering 10-kHz SCS.Main outcomes and measuresThe prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.ResultsOf 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).Conclusions and relevanceSubstantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN.Trial registrationClincalTrials.gov Identifier: NCT03228420.

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High-frequency 10?kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.

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High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain: Cost-consequence and Cost-effectiveness Analyses.

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