Kumar Krishna, Taylor Rod S, Jacques Line, Eldabe Sam, Meglio Mario, Molet Joan, Thomson Simon, O'Callaghan Jim, Eisenberg Elon, Milbouw Germain, Buchser Eric, Fortini Gianpaolo, Richardson Jonathan, North Richard B
Department of Neurosurgery, Regina General Hospital, 1440 14th Avenue, Regina, Sask., Canada.
Pain. 2007 Nov;132(1-2):179-88. doi: 10.1016/j.pain.2007.07.028. Epub 2007 Sep 12.
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 1 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<or=0.05 for all comparisons). Between 6 and 12 months, 5 SCS patients crossed to CMM, and 32 CMM patients crossed to SCS. At 12 months, 27 SCS patients (32%) had experienced device-related complications. In selected patients with FBSS, SCS provides better pain relief and improves health-related quality of life and functional capacity compared with CMM alone.
继发于腰椎手术失败综合征（FBSS）的神经性疼痛患者通常会经历持续性疼痛、功能障碍和生活质量下降。我们假设，对于这一患者群体，脊髓刺激（SCS）除了传统药物治疗（CMM）外，还是一种有效的治疗方法。我们将100例以神经性根性起源为主的腿部疼痛的FBSS患者随机分为两组，一组接受脊髓刺激加传统药物治疗（SCS组），另一组仅接受传统药物治疗（CMM组），治疗时间至少为6个月。主要结局是腿部疼痛缓解50%或更多的患者比例。次要结局包括腰腿痛改善情况、健康相关生活质量、功能能力、止痛药物和非药物疼痛治疗的使用情况、患者满意度水平以及并发症和不良反应的发生率。允许在6个月随访后进行交叉治疗，所有患者随访至1年。在6个月时的意向性分析中，24例SCS组患者（48%）和4例CMM组患者（9%）（p<0.001）达到主要结局。与CMM组相比，SCS组在腿部和腰腿痛缓解、生活质量和功能能力方面均有改善，治疗满意度也更高（所有比较p≤0.05）。在6至12个月期间，5例SCS组患者交叉至CMM组，32例CMM组患者交叉至SCS组。在12个月时，27例SCS组患者（32%）出现了与设备相关的并发症。在选定的FBSS患者中，与单纯CMM相比，SCS能更好地缓解疼痛，改善健康相关生活质量和功能能力。
