Anesthesia, McMaster University, Hamilton, Ontario, Canada
James Cook University Hospital, Middlesbrough, UK.
Reg Anesth Pain Med. 2023 Jun;48(6):251-272. doi: 10.1136/rapm-2022-103820. Epub 2023 Mar 30.
BACKGROUND/IMPORTANCE: Patient selection for spinal cord stimulation (SCS) therapy is crucial and is traditionally performed with clinical selection followed by a screening trial. The factors influencing patient selection and the importance of trialing have not been systematically evaluated.
We report a narrative review conducted to synthesize evidence regarding patient selection and the role of SCS trials.
Medline, EMBASE and Cochrane databases were searched for reports (any design) of SCS in adult patients, from their inception until March 30, 2022. Study selection and data extraction were carried out using DistillerSR. Data were organized into tables and narrative summaries, categorized by study design. Importance of patient variables and trialing was considered by looking at their influence on the long-term therapy success.
Among 7321 citations, 201 reports consisting of 60 systematic reviews, 36 randomized controlled trials (RCTs), 41 observational studies (OSs), 51 registry-based reports, and 13 case reports on complications during trialing were included. Based on RCTs and OSs, the median trial success rate was 72% and 82%, and therapy success was 65% and 61% at 12 months, respectively. Although several psychological and non-psychological determinants have been investigated, studies do not report a consistent approach to patient selection. Among psychological factors, untreated depression was associated with poor long-term outcomes, but the effect of others was inconsistent. Most RCTs except for chronic angina involved trialing and only one RCT compared patient selection with or without trial. The median (range) trial duration was 10 (0-30) and 7 (0-56) days among RCTs and OSs, respectively.
Due to lack of a consistent approach to identify responders for SCS therapy, trialing complements patient selection to exclude patients who do not find the therapy helpful and/or intolerant of the SCS system. However, more rigorous and large studies are necessary to better evaluate its role.
背景/重要性:脊髓刺激 (SCS) 治疗的患者选择至关重要,传统上采用临床选择,然后进行筛选试验。影响患者选择的因素以及试验的重要性尚未得到系统评估。
我们报告了一项叙述性综述,旨在综合有关患者选择和 SCS 试验作用的证据。
从成立之初到 2022 年 3 月 30 日,在 Medline、EMBASE 和 Cochrane 数据库中搜索了成人患者接受 SCS 的报告(任何设计)。使用 DistillerSR 进行研究选择和数据提取。根据研究设计将数据组织到表格和叙述性摘要中。通过观察它们对长期治疗成功的影响,考虑了患者变量和试验的重要性。
在 7321 条引文中,有 201 份报告,其中包括 60 项系统评价、36 项随机对照试验 (RCT)、41 项观察性研究 (OS)、51 项基于登记的报告和 13 份关于试验期间并发症的病例报告。基于 RCT 和 OS,试验成功率中位数分别为 72%和 82%,12 个月时的治疗成功率分别为 65%和 61%。尽管已经研究了几种心理和非心理决定因素,但研究并未报告一致的患者选择方法。在心理因素中,未经治疗的抑郁症与长期预后不良相关,但其他因素的影响不一致。除了慢性心绞痛之外,大多数 RCT 都涉及试验,只有一项 RCT 比较了有或没有试验的患者选择。RCT 和 OS 中的试验持续时间中位数(范围)分别为 10(0-30)和 7(0-56)天。
由于缺乏一致的方法来识别 SCS 治疗的反应者,因此试验补充了患者选择,以排除那些发现治疗无益和/或不能耐受 SCS 系统的患者。然而,需要进行更严格和更大规模的研究,以更好地评估其作用。