协同神经调节疗法治疗持续性脊柱疼痛:一项关于脊髓和背根神经节刺激应用的概念验证试验
Synergistic neuromodulation therapy for persistent spinal pain: a proof-of-concept trial on the use of spinal cord and dorsal root ganglion stimulation.
作者信息
Fiedler Augusto Müller, Piedade Guilherme Santos, Assumpção de Monaco Bernardo, Taylor Ruby Rose, Williams Michelle Dawn, Danny John L, Minor Adrienne, Cordeiro Joacir Graciolli
机构信息
Department of Neurological Surgery, University of Miami, 1475 NW 12th Ave, Miami, FL, 33136, USA.
Division of Neurosurgery, Clinics Hospital, University of São Paulo, São Paulo, Brazil.
出版信息
Acta Neurol Belg. 2024 Oct;124(5):1611-1616. doi: 10.1007/s13760-024-02575-0. Epub 2024 May 18.
PURPOSE
Persistent Spinal Pain Syndrome type 2 (PSPS-T2) poses a significant clinical challenge, demanding innovative therapeutic interventions. The integration of Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion Stimulation (DRG-S) is emerging as a potent synergistic strategy for comprehensive pain management. This single patient-blind proof of concept (POC) trial explores the efficacy and synergistic potential of combined SCS and DRG-S in a patient with refractory PSPS-T2.
METHODS
A 45-year-old male with intractable PSPS-T2 underwent a unique, methodically structured study, involving three treatment phases: Phase A with SCS alone, Phase B with DRG-S alone, and Phase C The patient, blinded to the treatment modalities, provided pain assessments using the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN4) conducted by clinical investigators at each phase. Baseline pain scores were ten and nine, respectively.
RESULTS
Distinct responses were noted across the phases. Phase A demonstrated moderate pain relief, while Phase B offered further pain intensity reduction. However, Phase C, combining both strategies, yielded the most significant improvement, remarkably enhancing the patient's quality of life and functional capacity.
CONCLUSION
This POC trial underscores the synergistic potential of SCS and DRG-S in managing complex cases of PSPS-T2, suggesting a paradigm shift towards integrated neuromodulation strategies for enhanced pain control. The development of dual intent implantable pulse generators (IPGs) capable of offering combination therapy simultaneously might be effective for pain management in select cases. The significant pain reduction and functional improvement observed advocate for further research in dual neuromodulation therapies.
TRIAL REGISTRATION NUMBER
IRB 20190536.
目的
2型持续性脊柱疼痛综合征(PSPS-T2)带来了重大的临床挑战,需要创新的治疗干预措施。脊髓刺激(SCS)和背根神经节刺激(DRG-S)的整合正在成为一种有效的协同策略,用于全面的疼痛管理。这项单病例盲法概念验证(POC)试验探讨了联合SCS和DRG-S在一名难治性PSPS-T2患者中的疗效和协同潜力。
方法
一名45岁患有顽固性PSPS-T2的男性患者接受了一项独特的、精心设计的研究,包括三个治疗阶段:A阶段仅采用SCS,B阶段仅采用DRG-S,C阶段将两者结合。对治疗方式不知情的患者在每个阶段通过视觉模拟量表(VAS)和临床研究人员进行的神经病理性疼痛4项问题(DN4)评估提供疼痛评分。基线疼痛评分分别为10分和9分。
结果
各阶段观察到不同的反应。A阶段显示出中度疼痛缓解,而B阶段疼痛强度进一步降低。然而,C阶段结合了两种策略,带来了最显著的改善,显著提高了患者的生活质量和功能能力。
结论
这项POC试验强调了SCS和DRG-S在处理复杂PSPS-T2病例中的协同潜力,表明朝着整合神经调节策略以加强疼痛控制的模式转变。开发能够同时提供联合治疗的双功能植入式脉冲发生器(IPG)可能对某些病例的疼痛管理有效。观察到的显著疼痛减轻和功能改善支持对双神经调节疗法进行进一步研究。
试验注册号
IRB 20190536。