BACKGROUND Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN. METHODS In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm-on a 0- to 10-cm visual analog scale (VAS)-in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on. DISCUSSION Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM. TRIAL REGISTRATION ClincalTrials.gov identifier: NCT03228420 (registered 24 July 2017).

中文翻译：

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10 kHz高频脊髓刺激治疗糖尿病性神经病变：一项多中心，随机对照试验（SENZA-PDN）的设计。

背景技术痛苦的糖尿病性神经病（PDN）是一种严重影响生活质量的使人衰弱的进行性慢性疼痛病症，是长期存在的糖尿病常见的并发症之一。药物治疗和低频脊髓刺激（SCS）都没有为PDN患者提供长期有效的疼痛缓解。这项研究旨在证明难治性PDN患者除常规医疗管理（CMM）之外，与单独的CMM相比，还有10 kHz SCS的价值。方法在一项前瞻性，多中心，随机对照试验（SENZA-PDN）中，将在适当的机构审查委员会批准后，将216名PDN患者分配给1：1接受10 kHz SCS联合CMM或CMM的受试者，并随访24个月。主要纳入标准包括（1）PDN症状持续至少12个月；（2）下肢0至10 cm视觉模拟量表（VAS）上的平均疼痛强度至少5 cm，以及（ 3）SCS的合适候选人。关键的排除标准包括（1）上肢VAS上的大或坏疽性溃疡或（2）VAS的平均疼痛强度至少3 cm。除疼痛VAS外，还将捕获神经系统评估，与健康相关的生活质量，睡眠质量和患者满意度。比较治疗组之间缓解率（≥50％缓解疼痛）和安全率的主要终点指标将在3个月时评估。还将报告几个次要端点。讨论注册于2017年开始，并于2019年完成。这项研究将有助于确定10 kHz SCS是否能改善临床结果和与健康相关的生活质量，并且是对CMM难治的PDN的一种经济有效的治疗方法。试用注册ClincalTrials.gov标识符：NCT03228420（2017年7月24日注册）。