1Department of Neurosurgery, Universitair Ziekenhuis Brussel, Jette.
2Center for Neurosciences (C4N), Vrije Universiteit Brussel, Jette.
J Neurosurg Spine. 2020 Dec 18;34(3):440-448. doi: 10.3171/2020.7.SPINE20764. Print 2021 Mar 1.
In recent years, the use of high-dose spinal cord stimulation (HD-SCS) as a treatment option for patients with failed back surgery syndrome (FBSS) has drastically increased. However, to the authors' knowledge a thorough evaluation of health-related quality of life (HRQOL) and work status in these patients has not yet been performed. Moreover, it is unclear whether patients who are treated with HD-SCS can regain the same levels of HRQOL as the general population. Therefore, the aims of this study were to compare the HRQOL of patients who receive HD-SCS to HRQOL values in an age- and sex-adjusted population without FBSS and to evaluate work status in patients who are receiving HD-SCS.
HRQOL, measured with the 3-level EQ-5D (EQ-5D-3L), and work status were evaluated in 185 FBSS patients at baseline (i.e., before SCS) and at 1, 3, and 12 months of treatment with HD-SCS. Difference scores in utility values between patients and an age- and sex-adjusted normal population were calculated. One-sample Wilcoxon tests were used to assess the EQ-5D-3L difference scores. Mixed models were used to evaluate the evolution over time in EQ-5D-3L utility scores and EQ-5D visual analog scale (VAS) scores in patients and matched controls. Quality-adjusted life-years (QALYs) were calculated using the area under the curve method.
An overall significant increase in EQ-5D-3L utility scores and EQ-5D VAS scores was found over time in the patient group. Wilcoxon tests indicated that the difference scores in utility values between patients and the normal population were significantly different from zero at all time points. The median incremental QALY after 12 months of HD-SCS was 0.228 (Q1-Q3: 0.005-0.487) in comparison to continued conservative treatment. At 12 months, 13.75% of patients resumed work.
HD-SCS may lead to significantly increased HRQOL at 12 months in patients with FBSS. Despite the increase, reaching the HRQOL level of matched controls was not achieved. Only a limited number of patients were able to return to work. This finding indicates that specialized programs to enhance return to work may be beneficial for patients undergoing SCS.
近年来，高剂量脊髓刺激（HD-SCS）作为治疗失败性腰椎手术综合征（FBSS）患者的选择方案，其使用率急剧上升。然而，据作者所知，对于这些患者的健康相关生活质量（HRQOL）和工作状况尚未进行全面评估。此外，尚不清楚接受 HD-SCS 治疗的患者是否能够恢复与普通人群相同的 HRQOL 水平。因此，本研究的目的是比较接受 HD-SCS 治疗的患者的 HRQOL 与年龄和性别相匹配的无 FBSS 人群的 HRQOL 值，并评估接受 HD-SCS 治疗的患者的工作状况。
在基线（即 SCS 治疗前）和接受 HD-SCS 治疗 1、3 和 12 个月时，使用 3 级 EQ-5D（EQ-5D-3L）评估 185 例 FBSS 患者的 HRQOL 和工作状况。计算患者与年龄和性别相匹配的正常人群之间效用值的差异分数。使用单样本 Wilcoxon 检验评估 EQ-5D-3L 差异分数。使用混合模型评估患者和匹配对照组在 EQ-5D-3L 效用评分和 EQ-5D 视觉模拟量表（VAS）评分随时间的演变。使用曲线下面积法计算质量调整生命年（QALY）。
患者组的 EQ-5D-3L 效用评分和 EQ-5D VAS 评分随时间呈总体显著增加。Wilcoxon 检验表明，在所有时间点，患者与正常人群之间的效用值差异分数均显著不为零。与继续保守治疗相比，接受 12 个月 HD-SCS 后，患者的中位数增量 QALY 为 0.228（Q1-Q3：0.005-0.487）。在 12 个月时，13.75%的患者恢复工作。
在 FBSS 患者中，HD-SCS 可能导致 12 个月时 HRQOL 显著增加。尽管有所增加，但并未达到与匹配对照组相同的 HRQOL 水平。只有少数患者能够重返工作岗位。这一发现表明，为接受 SCS 治疗的患者提供专门的重返工作方案可能是有益的。
