多柱脊髓刺激治疗失败的脊柱手术综合征所致严重腰痛：一项全国性、多中心、随机对照卫生经济学试验（ESTIMET研究）的设计

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).

作者信息

Roulaud M, Durand-Zaleski I, Ingrand P, Serrie A, Diallo B, Peruzzi P, Hieu P D, Voirin J, Raoul S, Page P, Fontaine D, Lantéri-Minet M, Blond S, Buisset N, Cuny E, Cadenne M, Caire F, Ranoux D, Mertens P, Naous H, Simon E, Emery E, Gadan B, Regis J, Sol J-C, Béraud G, Debiais F, Durand G, Guetarni Ging F, Prévost A, Brandet C, Monlezun O, Delmotte A, d'Houtaud S, Bataille B, Rigoard P

机构信息

N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.

Clinical Research Unit in Economics, Hôtel Dieu, 75004 Paris, France.

出版信息

Neurochirurgie. 2015 Mar;61 Suppl 1:S109-16. doi: 10.1016/j.neuchi.2014.10.105. Epub 2014 Nov 20.

DOI:10.1016/j.neuchi.2014.10.105

PMID:25456442

Abstract

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.

摘要

背景

近几十年来，许多研究已证明脊髓刺激（SCS）对慢性神经性根性疼痛有效，但尽管在伴有腿部疼痛的失败脊柱手术综合征（FBSS）中取得了总体良好的效果，但神经刺激对背痛部分的控制仍然较差。技术和科学的进步促使了新型SCS电极的开发，包括多柱设计和更多的触点。初步研究表明，多柱SCS电极配置对治疗FBSS的背痛部分有效。然而，必须进行随机对照试验以证实新一代多柱SCS的疗效。多柱脊髓刺激的医学经济学评估（ESTIMET）是一项多中心随机研究，旨在比较单柱与多柱SCS电极程控在伴有根性疼痛和明显背痛的FBSS患者中的临床疗效和卫生经济学方面。

材料与方法

在法国的14个中心招募了根性疼痛视觉模拟评分（VAS）≥50mm且伴有明显背痛的FBSS患者，并植入多柱SCS。在电极植入手术前，他们被1:1随机分为单柱SCS组（第1组）或多柱SCS组（第2组）。第1组仅使用一根柱进行程控，第2组充分使用3根柱。在基线（植入前）、植入后1、3、6和12个月进行结果评估。主要结局指标是在6个月随访时下背痛严重程度降低（背痛VAS降低≥50%）。其他结局指标包括总体疼痛、腿部疼痛、感觉异常覆盖范围映射、功能能力、生活质量、神经心理学方面、患者满意度和医疗资源消耗的变化。