脊髓刺激器疗法失效：临床证据与可能原因。

Loss of Efficacy to Spinal Cord Stimulator Therapy: Clinical Evidence and Possible Causes.

机构信息

Mayo Clinic School of Medicine, Rochester, MN.

Tufts University School of Medicine, Boston, MA.

出版信息

Pain Physician. 2017 Nov;20(7):E1073-E1080.

PMID:29149152

Abstract

BACKGROUND

Although spinal cord stimulation (SCS) therapy has been shown to be efficacious in various pain conditions, the ability for SCS therapy to maintain long-term efficacy has been questioned.

OBJECTIVE

The purpose of this study was to investigate whether a loss of efficacy (LOE) phenomenon exists with SCS therapy and to investigate if this phenomenon is more apparent in any specific patient population.

STUDY DESIGN

A retrospective, observation chart review was conducted to evaluate the patient response to SCS therapy over time.

SETTING

Massachusetts General Hospital, Boston, Massachusetts.

METHODS

Patients who received a SCS at the Massachusetts General Hospital, between January 1, 2002 and December 31, 2012, were invited to participate. A total of 62 patients were included in this study. Various models were created to analyze pain score changes over time using 2-tailed statistical analysis. Additionally, one-way ANOVA and Pearson's chi-square tests were used to determine if certain patient characteristics were associated with LOE.

RESULTS

Compared to the visual analog scale (VAS) score at one month after device implantation, pain scores increased 1.95 points after 2 years (95% CI: 1.06 to 2.84, P = < 0.001). There were no significant differences in baseline characteristics between the groups of patients who did and did not lose efficacy of their therapy. However, those who experienced LOE had a baseline SCS therapy VAS score 3.09 points lower than those who did not (95% CI: 1.69 to 4.48, P = < 0.001).

LIMITATIONS

This study had several limitations including the retrospective nature of its design, confounders to VAS scores, small sample size, missing data points, and the evaluation of only conventional, low-frequency SCS therapy.

CONCLUSIONS

Patients who received a SCS had a significant increase in VAS scores over time. Our data did not show any baseline patient characteristic that helped predict LOE. However, patients who have significant baseline response to therapy may be more likely to experience LOE.

KEY WORDS

Spinal cord stimulation, chronic pain, retrospective study, low frequency electrical stimulation, efficacy, chronic pain therapy.

摘要

背景

尽管脊髓刺激（SCS）疗法已被证明在各种疼痛病症中具有疗效，但 SCS 疗法维持长期疗效的能力一直受到质疑。

目的

本研究旨在探讨 SCS 疗法是否存在疗效丧失（LOE）现象，以及这种现象是否在特定患者群体中更为明显。

研究设计

对 SCS 治疗患者的随时间推移的反应进行回顾性、观察性图表审查。

地点

马萨诸塞州总医院，波士顿，马萨诸塞州。

方法

邀请 2002 年 1 月 1 日至 2012 年 12 月 31 日期间在马萨诸塞州总医院接受 SCS 的患者参加研究。共有 62 名患者纳入本研究。使用双尾统计分析创建了各种模型来分析随时间推移的疼痛评分变化。此外，还使用单向方差分析和 Pearson 卡方检验来确定特定患者特征是否与 LOE 相关。

结果

与设备植入后一个月的视觉模拟量表（VAS）评分相比，2 年后疼痛评分增加了 1.95 分（95%CI：1.06 至 2.84，P < 0.001）。在 LOE 组和未 LOE 组之间，患者的基线特征无显著差异。然而，经历 LOE 的患者的基线 SCS 治疗 VAS 评分比未经历 LOE 的患者低 3.09 分（95%CI：1.69 至 4.48，P < 0.001）。