Spinal cord stimulation vs. conventional medical management: A prospective, randomized, controlled, multicenter study of patients with failed back surgery syndrome (PROCESS study)
Spinal cord stimulation vs. conventional medical management: A prospective, randomized, controlled, multicenter study of patients with failed back surgery syndrome (PROCESS study)
复制标题
DOI：
10.1111/j.1525-1403.2005.00027.x
复制
发表时间：
2005-10-01
期刊：
影响因子：
2.8
通讯作者：
Jacobs, M
中科院分区：
文献类型：
--
作者：
Kumar, K;North, R;Jacobs, M
介绍。自 1967 年首次应用以来，大量病例系列表明脊髓刺激 (SCS) 是治疗背部手术失败综合征 (FBSS) 的有效方法。然而，只有一项随机对照试验表明，SCS 比再次手术和传统医疗管理更能有效缓解疼痛。 PROCESS 随机、对照、多中心试验旨在评估 FBSS 患者在传统医疗管理中加入 SCS 与单独使用传统医疗管理相比的临床有效性和成本效益。方法/设计。将从 12 个中心招募总共 100 名主要患有神经性腿部疼痛的 FBSS 患者，并随机接受单独的常规医疗治疗或与 SCS 相结合，为期 24 个月。患者将在 1、3、6、9、12、18 和 24 个月时接受评估。在 6 个月的访视中，患者将被分为成功（腿部疼痛缓解 >= 50%）或不成功（腿部疼痛缓解 < 50%）。如果随机治疗的结果不成功，患者可以转到替代治疗组。讨论。本文重点介绍了一项正在进行的前瞻性、随机、对照、多中心临床试验的基本原理、设计、方法和挑战，该试验的目的是获得 SCS 系统对 FBSS 患者的临床疗效和成本效益的确凿证据。
Introduction. Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re-operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost-effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS.Methods/Design. A total of 100 FBSS patients with predominantly neuropathic leg pain will be recruited from 12 centers and randomized to receive either conventional medical management alone or in combination with SCS for a period of 24 months. Patients will be evaluated at 1, 3, 6, 9, 12, 18, and 24 months. At the 6-month visit, patients will be classified as successful (>= 50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm.Discussion. This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost-effectiveness of an SCS system in patients with FBSS.