Petersen Erika A, Sills Shawn M, Stauss Thomas G, Province-Azalde Rose, Jaasma Michael J, Edgar Deborah R, White Judith L, Scowcroft James A, Yu Cong, Xu Jijun, Guirguis Maged N, Amirdelfan Kasra, DiBenedetto David J, Nairizi Ali, Lad Shivanand P, Mehta Neel D, Sayed Dawood, Sethi Khalid A, Benducci Sarah, Bharara Manish
University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Touchstone Interventional Pain Center, Medford, Oregon, USA.
Pain Pract. 2025 Jun;25(5):e70023. doi: 10.1111/papr.70023.
To evaluate the longer-term efficacy of 10 kHz spinal cord stimulation (SCS) in managing painful diabetic neuropathy (PDN) in a routine clinical setting after the transition from the 24-month SENZA-PDN study.
We contacted 142 participants who completed 24 months of postimplantation follow-up in the former randomized controlled trial (SENZA-PDN). Of these, 57 consented and responded to this longer-term post-study survey. Outcomes assessed included pain relief, health-related quality of life (HRQoL) measured using the EuroQol 5-Dimensional 5-Level (EQ-5D-5L) instrument, Patient Global Impression of Change (PGIC), HbA1c, and weight.
Our survey captured patient-reported outcomes at a median of 4.1 years after implantation of a permanent 10 kHz SCS system. Among the surveyed participants, 76.8% (43 of 56) reported clinically meaningful pain relief (≥2 points), and 84.6% (44 of 52) achieved a clinically meaningful improvement in their EQ-5D-5L index score, with a final mean EQ-5D-5L index score of 0.825. Additionally, 74.5% (38 of 51) reported being "Better" or "A great deal better" on the PGIC scale. The surveyed participants reported a mean HbA1c level decrease of 0.4% (p = 0.027), with a more substantial improvement of 1.6% (p < 0.001) among those with type 2 diabetes (T2D) and a higher preimplantation HbA1c (>8%). Significant weight loss was also observed, with a mean reduction of 7.0 kg (p < 0.001) in the overall cohort and 8.7 kg (p < 0.001) in the subgroup with T2D and a higher BMI at preimplantation (≥35 kg/m).
High-frequency SCS at 10 kHz provided sustained and clinically meaningful improvements in pain and HRQoL for PDN patients at 4.1 years postimplantation, with no explants in the cohort due to inefficacy. Alongside these benefits, participants experienced metabolic changes that included reductions in body weight and HbA1c beyond that achieved at 24 months, although changes in lifestyle and medication were not accounted for in this analysis. Notably, the cohort's final mean EQ-5D-5L index score was comparable to the US norm. These findings support 10 kHz SCS as a durable and effective treatment option for PDN in routine clinical practice.
在从为期24个月的SENZA-PDN研究过渡后，评估10kHz脊髓刺激（SCS）在常规临床环境中治疗疼痛性糖尿病神经病变（PDN）的长期疗效。
我们联系了142名在前一项随机对照试验（SENZA-PDN）中完成了24个月植入后随访的参与者。其中，57名同意并回复了这项长期研究后调查。评估的结果包括疼痛缓解、使用欧洲五维度五水平（EQ-5D-5L）工具测量的健康相关生活质量（HRQoL）、患者整体改善印象（PGIC）、糖化血红蛋白（HbA1c）和体重。
我们的调查在永久性10kHz SCS系统植入后的中位时间4.1年时获取了患者报告的结果。在接受调查的参与者中，76.8%（56名中的43名）报告有临床意义的疼痛缓解（≥2分），84.6%（52名中的44名）在EQ-5D-5L指数评分上有临床意义的改善，最终平均EQ-5D-5L指数评分为0.825。此外，74.5%（51名中的38名）在PGIC量表上报告“有所改善”或“改善很多”。接受调查的参与者报告HbA1c水平平均下降0.4%（p = 0.027），2型糖尿病（T2D）患者且植入前HbA1c较高（>8%）的人群改善更为显著，为1.6%（p < 0.001）。还观察到显著的体重减轻，总体队列平均减轻7.0kg（p < 0.001），T2D且植入前BMI较高（≥35kg/m²）的亚组平均减轻8.7kg（p < 0.001）。
10kHz的高频SCS在植入后4.1年为PDN患者提供了持续且具有临床意义的疼痛和HRQoL改善效果，该队列中无因无效而取出植入物的情况。除了这些益处，参与者还经历了代谢变化，包括体重和HbA1c的降低，且超过了24个月时所达到的水平，尽管本分析未考虑生活方式和药物的变化。值得注意的是，该队列最终的平均EQ-5D-5L指数评分与美国标准相当。这些发现支持10kHz SCS作为PDN在常规临床实践中的一种持久且有效的治疗选择。
