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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

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引用本文的文献

[1]
Spinal cord stimulation for low back pain.

Cochrane Database Syst Rev. 2023-3-7

[2]
Combining Awake Anesthesia with Minimal Invasive Surgery Optimizes Intraoperative Surgical Spinal Cord Stimulation Lead Placement.

J Clin Med. 2022-9-22

[3]
Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study).

Medicina (Kaunas). 2021-12-21

[4]
A Systematic Review of the Cost-Utility of Spinal Cord Stimulation for Persistent Low Back Pain in Patients With Failed Back Surgery Syndrome.

Global Spine J. 2021-4

[5]
A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

Trials. 2018-1-24

[6]
Neuropathic Pain after Spinal Surgery.

Asian Spine J. 2017-8

[7]
A review of spinal cord stimulation systems for chronic pain.

J Pain Res. 2016-7-1

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