Objective Randomized trials have demonstrated efficacy of spinal cord stimulation (SCS) for treatment of painful diabetic neuropathy (PDN). Preliminary data suggested that treatment of PDN with high-frequency SCS resulted in improvements on neurological examination. The purpose of the present study was to explore whether patients with PDN treated with high-frequency SCS would have improvements in lower-extremity peripheral nerve function. Design Prospective cohort study in an outpatient clinical practice at a tertiary care center. Methods Patients with PDN were treated with high-frequency SCS and followed up for 12 months after SCS implantation with clinical outcomes assessments of pain intensity, neuropathic symptoms, and neurological function. Small-fiber sudomotor function was assessed with the quantitative sudomotor axon reflex test (QSART), and large-fiber function was assessed with nerve conduction studies (NCS). Lower-extremity perfusion was assessed with laser Doppler flowmetry. Results Nine patients completed 12-month follow-up visits and were observed to have improvements in lower-extremity pain, weakness, and positive sensory symptoms. Neuropathy impairment scores were improved, and 2 patients had recovery of sensory responses on NCS. A reduction in sweat volume on QSART was observed in the proximal leg but not at other sites. No significant differences were noted in lower-extremity perfusion or NCS as compared with baseline. Conclusions The improvement in pain relief was concordant with improvement in neuropathy symptoms. The findings from this study provide encouraging preliminary data in support of the hypothesis of a positive effect of SCS on peripheral neuropathy, but the findings are based on small numbers and require further evaluation. Trial registration ClinicalTrials.gov ID NCT03769675.

中文翻译：

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高频脊髓刺激后疼痛性糖尿病周围神经病变的定量评估：一项试点研究

目的 随机试验证明脊髓刺激 (SCS) 对治疗疼痛性糖尿病神经病变 (PDN) 的疗效。初步数据表明，高频 SCS 治疗 PDN 可以改善神经系统检查。本研究的目的是探讨接受高频 SCS 治疗的 PDN 患者下肢周围神经功能是否会有所改善。在三级护理中心的门诊临床实践中设计前瞻性队列研究。方法 PDN 患者接受高频 SCS 治疗，并在 SCS 植入后随访 12 个月，评估疼痛强度、神经病理症状和神经功能的临床结果。通过定量催汗轴突反射试验（QSART）评估小纤维催汗功能，通过神经传导研究（NCS）评估大纤维功能。用激光多普勒血流计评估下肢灌注。结果 9 名患者完成了 12 个月的随访，观察到下肢疼痛、无力和阳性感觉症状有所改善。神经病变损伤评分得到改善，2 名患者的 NCS 感觉反应恢复。在 QSART 中观察到近端腿的出汗量减少，但其他部位没有观察到。与基线相比，下肢灌注或 NCS 没有显着差异。结论 疼痛缓解的改善与神经病变症状的改善一致。这项研究的结果提供了令人鼓舞的初步数据，支持 SCS 对周围神经病变有积极作用的假设，但这些结果基于少量数据，需要进一步评估。试验注册 ClinicalTrials.gov ID NCT03769675。