Eldabe Sam, Gulve Ashish, Thomson Simon, Baranidharan Ganesan, Duarte Rui, Jowett Susan, Sandhu Harbinder, Chadwick Raymond, Brookes Morag, Tariq Anisah, Earle Jenny, Bell Jill, Kansal Anu, Rhodes Shelley, Taylor Rod S
The James Cook University Hospital, Middlesbrough, UK.
Basildon and Thurrock University Hospitals, Basildon, UK.
Trials. 2018 Nov 16;19(1):633. doi: 10.1186/s13063-018-2993-9.
The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device.
METHODS/DESIGN: The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index), patient satisfaction (Patients' Global Impression of Change) and complication rates. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. The economic evaluation will take the form of a cost-utility analysis.
The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The nested qualitative study will seek to explore the patient's view of the screening trials, implantation and overall use of SCS.
ISRCTN, ISRCTN60778781 . Registered on 15 August 2017.
TRIAL-STIM研究旨在评估在完全植入脊髓刺激（SCS）设备之前进行筛查试验的诊断性能、临床结果和成本效益。
方法/设计：TRIAL-STIM研究是一项针对慢性神经性疼痛患者的优效性、平行组、三中心随机对照试验，同时进行嵌套定性研究和经济评估。该研究将在英国的三个中心进行：南泰晤士医院国民保健服务信托基金（詹姆斯库克大学医院）；巴西尔登和瑟罗克大学医院国民保健服务信托基金；以及利兹教学医院国民保健服务信托基金。总共将纳入100名接受SCS植入治疗神经病变的成年人。研究对象将从三个参与地点的门诊诊所招募，并按1:1的比例随机分为在SCS植入前进行筛查试验或仅采用植入策略。分配将按中心分层，并根据患者年龄（≥65岁或<65岁）、性别、是否存在失败的脊柱手术综合征以及是否使用高频（HF10™）进行最小化。主要结局指标是筛查试验与植入策略和仅植入策略相比，6个月时的数字评分量表（NRS）。次要结局指标将包括诊断准确性、6个月时在NRS上测量的至少实现50%和30%疼痛缓解的患者比例、健康相关生活质量（EQ-5D）、功能（Oswestry残疾指数）、患者满意度（患者对变化的总体印象）和并发症发生率。将对每个中心招募的30名患者（每个中心10名）同时进行嵌套定性研究，以探讨他们对筛查试验、植入和SCS设备总体使用的看法。经济评估将采用成本效用分析的形式。
TRIAL-STIM研究是一项随机对照试验，同时进行嵌套定性研究和经济评估，旨在确定SCS筛查试验的临床效用及其成本效益。嵌套定性研究将试图探索患者对筛查试验、植入和SCS总体使用的看法。
ISRCTN，ISRCTN60778781。于2017年8月15日注册。
