iSpine Pain Physicians, Maple Grove, MN, USA.
Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA.
Neuromodulation. 2022 Oct;25(7):947-955. doi: 10.1016/j.neurom.2022.04.043. Epub 2022 Jun 8.
In the spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRG-S) literature, the typical primary outcome measure includes pain relief, whether numeric rating scale changes or percentage pain relief, and functional outcomes and patient satisfaction are included as secondary outcomes. This systematic review and meta-analysis aims to determine the rate of patient satisfaction with the use of SCS and DRG-S in the treatment of chronic intractable pain.
The study protocol was registered in the PROSPERO International prospective register of systematic reviews. We queried articles from multiple electronic data bases, including MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials data bases, and hand-searched reference lists of identified publications. All periods were included. Inclusion criteria encompassed randomized controlled trials (RCTs) and prospective observational studies that reported patient satisfaction in patients who underwent SCS or DRG-S. Bias evaluation for the included studies involved appropriate guidelines for each study design (Cochrane risk of bias tool for RCTs and Newcastle-Ottawa scale for observational studies).
Our search strategy identified 242 unique citations, of which nine RCTs and 23 observational studies were included for analysis. Overall, 25 studies comprising 1355 participants were pooled in our quantitative analysis. The pooled proportion of patients who reported satisfaction from all studies was 82.2% (95% CI, 77.8%-86.2%). This finding had high statistical heterogeneity (I = 74.0%). Subgroup analysis did not reveal differences in satisfaction when studies were stratified based on study design (RCT or observational study) or follow-up period (six, 12, 24, and 36 months).
Our results show high levels of patient satisfaction across the SCS and DRG-S literature when these treatment modalities are used for chronic intractable pain, regardless of SCS programming algorithm. However, there is a scarcity of unbiased and/or non-industry-funded prospective studies in the neuromodulation field, and future efforts to expand this area of the SCS and DRG-S literature are greatly needed.
在脊髓刺激 (SCS) 和背根神经节刺激 (DRG-S) 的文献中，典型的主要疗效指标包括疼痛缓解，疼痛缓解的数字评分变化或百分比，以及功能结果和患者满意度作为次要疗效指标。本系统评价和荟萃分析旨在确定 SCS 和 DRG-S 在治疗慢性顽固性疼痛中的患者满意度率。
研究方案已在 PROSPERO 国际前瞻性系统评价注册中心注册。我们从多个电子数据库（包括 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册数据库）查询文章，并对已确定出版物的参考文献进行手工检索。所有时期都包括在内。纳入标准包括随机对照试验 (RCT) 和前瞻性观察研究，这些研究报告了接受 SCS 或 DRG-S 治疗的患者的患者满意度。纳入研究的偏倚评估涉及每种研究设计的适当指南（RCT 的 Cochrane 偏倚风险工具和观察性研究的 Newcastle-Ottawa 量表）。
我们的搜索策略确定了 242 个独特的引文，其中 9 项 RCT 和 23 项观察性研究被纳入分析。总体而言，我们的定量分析中包含了 25 项研究，共 1355 名参与者。所有研究中报告满意度的患者的合并比例为 82.2%（95%CI，77.8%-86.2%）。这一发现具有高度的统计学异质性（I=74.0%）。亚组分析表明，根据研究设计（RCT 或观察性研究）或随访时间（6、12、24 和 36 个月）对研究进行分层时，满意度没有差异。
我们的研究结果表明，在 SCS 和 DRG-S 文献中，当这些治疗方法用于慢性顽固性疼痛时，患者满意度水平较高，而与 SCS 编程算法无关。然而，在神经调节领域，缺乏无偏倚和/或非行业资助的前瞻性研究，因此迫切需要进一步开展这一领域的 SCS 和 DRG-S 文献研究。
