Objective Spinal cord stimulation at 10 kHz has provided effective pain relief and improved function in painful diabetic peripheral neuropathy. This study aims to confirm the clinical outcomes for 10-kHz spinal cord stimulation treatment of painful diabetic peripheral neuropathy and explore its impact on objective quantitative measures of nerve pathology and function. Methods This single–academic center, prospective, open-label, observational study examined the pain relief success of 10-kHz spinal cord stimulation in patients >18 years of age with diabetic peripheral neuropathy. Patients underwent skin biopsies to measure intra-epidermal nerve fiber densities and corneal confocal microscopy measurements before implantation and at the 3-, 6-, and 12-month follow-up visits. Numerical rating scale for pain, visual analog scale, neuropathy pain scale, Short Form-36, and Neuropen (pin prick and monofilament) assessments were also conducted. Results Eight patients met the criteria and were enrolled in the study. A successful trial was achieved in 7 subjects, and 6 completed the study. Significant pain relief (P < .001) was achieved at all follow-up visits. Neurological assessments showed reduced numbers of “absent” responses and increased “normal” responses from baseline to 12 months. Both proximal and distal intra-epidermal nerve fiber densities were higher at 12 months than at baseline (P < .01). Confocal microscopy measurements showed a steady increase in nerve density from baseline (188.8% increase at 12 months; P = .029). Conclusions We observed pain relief and improvements in sensory function after stimulation that were accompanied by increases in lower-limb intra-epidermal nerve fiber density and corneal nerve density. Further evaluation with a blinded and controlled study is needed to confirm the preliminary findings in this study.

中文翻译：

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高频脊髓刺激 (10 kHz) 改变疼痛性糖尿病神经病变的感觉功能和神经纤维密度：一项试点前瞻性开放标签研究

目的 10 kHz 脊髓刺激可有效缓解疼痛并改善糖尿病周围神经病变的功能。本研究旨在确认 10kHz 脊髓刺激治疗疼痛性糖尿病周围神经病变的临床结果，并探讨其对神经病理学和功能的客观定量测量的影响。方法 这项单学术中心、前瞻性、开放标签观察性研究检查了 10 kHz 脊髓刺激对 18 岁以上糖尿病周围神经病变患者的疼痛缓解效果。在植入前以及 3、6 和 12 个月的随访时，患者接受了皮肤活检以测量表皮内神经纤维密度和角膜共聚焦显微镜测量。还进行了疼痛数字评定量表、视觉模拟量表、神经病疼痛量表、Short Form-36 和 Neuropen（针刺和单丝）评估。结果 8 名患者符合标准并被纳入研究。7 名受试者的试验取得了成功，6 名受试者完成了研究。在所有随访中均实现了显着的疼痛缓解（P < .001）。神经学评估显示，从基线到 12 个月，“缺席”反应数量减少，“正常”反应数量增加。12 个月时近端和远端表皮内神经纤维密度均高于基线 (P < .01)。共焦显微镜测量显示神经密度较基线稳定增加（12 个月时增加 188.8%；P = .029）。结论 我们观察到刺激后疼痛缓解和感觉功能改善，同时下肢表皮内神经纤维密度和角膜神经密度增加。需要通过盲法和对照研究进行进一步评估，以证实本研究的初步结果。