Harvard Medical School, Department of Anesthesia, Critical Care and Pain Medicine, Division of Pain, Massachusetts General Hospital, Boston, MA.
Harvard Medical School, Boston, MA.
Pain Physician. 2020 Jan;23(1):E19-E30.
There is a dearth in our understanding of the factors that are predictive of successful spinal cord stimulator (SCS) trials and eventual conversion to permanent implants. Knowledge of these factors is important for appropriate patient selection and treatment optimization.
Although previous studies have explored factors predictive of trial success, few have examined the role of waveform in trial outcomes. This study sought to establish the relationship of neuraxial waveform and related measures to trial outcomes.
This study used a retrospective chart review design.
Data were retrospectively collected on 174 patients undergoing SCS trials upon institutional review board approval of the study protocol. Indications for SCS were: complex regional pain syndrome, failed back surgery syndrome with radicular symptoms, peripheral neuropathy, and axial low back pain. Descriptive statistics and logistic regression analyses were used to assess the association of demographic and clinical variables with SCS trial outcomes.
The study population comprised 56% women, had a median age of 55 (interquartile range [IQR], 44-64), and 32 of 174 (18%) patients failed SCS trials. Individuals with successful trials (>= 50% pain relief) were significantly younger and had a median age of 54 years (IQR, 42-60) compared to those who failed SCS trials (median age 66 years; IQR, 50-76; P = .005). Adjusting for age, gender, number of leads, pain category, and diagnoses: surgical history (odds ratio [OR] = 4.4; 95% confidence interval [CI], 1.3-15.8) and paresthesia-based tonic-stimulation (OR = 10.3; 95% CI, 1.7-62.0), but not burst or high frequency, were significantly associated with successful trials. Of note, the number of leads (whether dual or single), pain duration, characteristics, and category (nociceptive vs neuropathic) were not significant factors. An interaction between surgical spine history and lower extremity pain was significantly associated with a positive trial (P = .005).
This study was limited by its retrospective nature and focus on a patient population at a single major academic medical center.
Paresthesia-based tonic stimulation, age, and surgical history have significant effects on SCS trials. Prospective and randomized controlled studies may provide deeper insights regarding impact on costs and overall outcomes.IRB Approval #: 2018P002216.
Pain duration, pain location, spinal cord stimulator trial, stimulator waveform, surgical history.
我们对预测脊髓刺激器（SCS）试验成功和最终转为永久性植入物的因素知之甚少。了解这些因素对于患者的选择和治疗优化非常重要。
尽管先前的研究已经探讨了预测试验成功的因素，但很少有研究探讨波形在试验结果中的作用。本研究旨在确定脊轴波形及其相关指标与试验结果的关系。
本研究采用回顾性图表审查设计。
在机构审查委员会批准研究方案后，对 174 名接受 SCS 试验的患者的数据进行了回顾性收集。SCS 的适应证为：复杂性区域疼痛综合征、神经根症状的后路手术失败综合征、周围神经病和轴性腰痛。采用描述性统计和逻辑回归分析评估人口统计学和临床变量与 SCS 试验结果的关系。
研究人群中 56%为女性，中位年龄为 55 岁（四分位距 [IQR]，44-64），174 例患者中有 32 例（18%）试验失败。试验成功（>= 50%疼痛缓解）的患者明显较年轻，中位年龄为 54 岁（IQR，42-60），而试验失败的患者中位年龄为 66 岁（IQR，50-76；P =.005）。调整年龄、性别、导联数量、疼痛类别和诊断：手术史（比值比 [OR] = 4.4；95%置信区间 [CI]，1.3-15.8）和基于感觉的强直刺激（OR = 10.3；95%CI，1.7-62.0），但不是突发或高频，与试验成功显著相关。值得注意的是，导联数量（双导联还是单导联）、疼痛持续时间、特征和类别（伤害性 vs 神经性）均不是显著因素。手术脊柱病史和下肢疼痛之间的相互作用与试验阳性显著相关（P =.005）。
本研究受到其回顾性性质和仅关注单一主要学术医疗中心患者群体的限制。
基于感觉的强直刺激、年龄和手术史对 SCS 试验有显著影响。前瞻性和随机对照研究可能会更深入地了解对成本和整体结果的影响。IRB 批准号：2018P002216。
疼痛持续时间、疼痛部位、脊髓刺激器试验、刺激器波形、手术史。
