Canós-Verdecho Ángeles, Bermejo Ara, Castel Beatriz, Izquierdo Rosa, Robledo Ruth, Gallach Elisa, Sevilla Teresa, Argente Pilar, Huertas Ismael, Peraita-Costa Isabel, Morales-Suarez-Varela María
Multidisciplinary Pain Management Unit, La Fe University and Polytechnic Hospital, Av. de Fernando Abril Martorell, 106, 46026 Valencia, Spain.
Anaesthesiology Department, La Fe University and Polytechnic Hospital, Av. de Fernando Abril Martorell, 106, 46026 Valencia, Spain.
J Clin Med. 2025 Jan 20;14(2):652. doi: 10.3390/jcm14020652.
The aim of this study was to evaluate the effects of spinal cord stimulation (SCS) on pain, neuropathic symptoms, and other health-related metrics in patients with chronic painful peripheral neuropathy (PN) from multiple etiologies. A prospective single center observational longitudinal cohort study assessed SCS efficacy from April 2023 to May 2024, with follow-ups at 2, 4, 6, and 12 months in 19 patients suffering from the painful polyneuropathy of diverse etiologies: diabetic (DPN), idiopathic (CIAP), chemotherapy-induced (CIPN), and others. Patients were implanted with a neurostimulator (WaveWriter Alpha, Boston Scientific Corporation, Valencia, CA, USA) and percutaneous leads targeting the lower limbs (T10-T11) and, if necessary, the upper limbs (C4-C7). Stimulation programming was individualized based on patient preference and best response. Assessments were performed before and after implantation and included pain intensity (VAS and DN4), neuropathic pain symptoms (NPSI and SF-MPQ-2), autonomic symptoms (SFN-SIQ and SAS), sensory and small fiber nerve injury (UENS), functionality (GAF), sleep (CPSI), global impression of change (CGI and PGI), and quality of life (EQ-VAS and EQ-5D). Intra-epidermal nerve fiber density (IENFD) via skin biopsy was also performed at baseline (diagnostic) and after 12 months to assess potential small fiber re-growth. Statistical analyses were conducted to determine the evolution of treatment success. To date, 19 patients have undergone implantation and completed follow-up. SCS produced a significant consistent and sustained improvement in pain intensity by 49% in DN4 and 76% in VAS, in neuropathic pain symptoms by 73%, in autonomic symptoms by 26-30%, in the sensorimotor physical exam by 8%, in functionality by 44%, in sleep by 74%, and in quality of life (69% for EQ-VAS and 134% EQ-5D). Both clinicians and patients had a meaningful global impression of change, at 1.1 and 1.3, respectively. Distal intra-epidermal nerve fiber density improved by 22% at 12 months while proximal intra-epidermal nerve fiber density decreased by 18%. SCS is an effective therapy for managing various types of PN.
本研究的目的是评估脊髓刺激（SCS）对多种病因引起的慢性疼痛性周围神经病变（PN）患者的疼痛、神经病变症状及其他健康相关指标的影响。一项前瞻性单中心观察性纵向队列研究于2023年4月至2024年5月评估了SCS的疗效，对19例患有不同病因所致疼痛性多发性神经病变的患者进行了2个月、4个月、6个月和12个月的随访，病因包括糖尿病性（DPN）、特发性（CIAP）、化疗诱导性（CIPN）等。患者植入了神经刺激器（WaveWriter Alpha，美国波士顿科学公司，加利福尼亚州瓦伦西亚），经皮导线靶向下肢（T10 - T11），必要时靶向上肢（C4 - C7）。刺激程序根据患者偏好和最佳反应进行个体化设置。在植入前后进行评估，包括疼痛强度（VAS和DN4）、神经性疼痛症状（NPSI和SF - MPQ - 2）、自主神经症状（SFN - SIQ和SAS）、感觉和小纤维神经损伤（UENS）、功能（GAF）、睡眠（CPSI）、总体变化印象（CGI和PGI）以及生活质量（EQ - VAS和EQ - 5D）。在基线（诊断时）和12个月后还通过皮肤活检进行了表皮内神经纤维密度（IENFD）检测，以评估潜在的小纤维再生情况。进行统计分析以确定治疗成功的进展情况。迄今为止，19例患者已接受植入并完成随访。SCS使疼痛强度显著、持续改善，DN4改善49%，VAS改善76%；神经性疼痛症状改善73%；自主神经症状改善26% - 30%；感觉运动体格检查改善8%；功能改善44%；睡眠改善74%；生活质量改善（EQ - VAS改善69%，EQ - 5D改善134%）。临床医生和患者对总体变化的印象分别为1.1和1.3，均具有意义。12个月时，远端表皮内神经纤维密度提高了22%，而近端表皮内神经纤维密度下降了18%。SCS是治疗各种类型PN的有效疗法。
