Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome
Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome
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DOI：
10.1016/j.pain.2007.07.028
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发表时间：
2007-11-01
期刊：
影响因子：
7.4
通讯作者：
North, Richard B.
中科院分区：
文献类型：
--
作者：
Kumar, Krishna;Taylor, Rod S.;North, Richard B.
继发于背部手术失败综合征 (FBSS) 的神经性疼痛患者通常会经历持续性疼痛、残疾和生活质量下降。我们假设脊髓刺激（SCS）对于该患者群体是除常规医疗管理（CMM）之外的有效疗法。我们将 100 名以神经根性腿部疼痛为主的 FBSS 患者随机分组，接受脊髓刺激加常规药物治疗（SCS 组）或单独常规药物治疗（CMM 组）至少 6 个月。主要结果是腿部疼痛缓解 50% 或更多的患者比例。次要结局是背部和腿部疼痛的改善、与健康相关的生活质量、功能能力、止痛药物和非药物疼痛治疗的使用、患者满意度以及并发症和不良反应的发生率。 6 个月访视后允许交叉，所有患者均随访至 I 年。在 6 个月的意向治疗分析中，24 名 SCS 患者 (48%) 和 4 名 CMM 患者 (9%) (p < 0.001) 实现了主要结局。与 CMM 组相比，SCS 组的腿部和背部疼痛缓解、生活质量和功能能力得到改善，并且治疗满意度更高 (p
Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health-related quality of life, functional capacity, use of pain medication and non-drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6-months visit was permitted, and all patients were followed up to I year. In the intention-to-treat analysis at 6 months, 24 SCS patients (48%) and 4 CMM patients (9%) (p < 0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p