Abstract：
BACKGROUND: There are limited therapeutic options to treat complex regional pain syndrome (CRPS). Spinal cord stimulation and dorsal root ganglion stimulation are proven therapies for treating chronic low limb pain in CRPS patients. There is limited evidence that stimulation of dorsal nerve roots can also provide relief of lower limb pain in these patients.
OBJECTIVE: To demonstrate that electrical stimulation of dorsal nerve roots via epidural lead placement provides relief of chronic lower limb pain in patients suffering from CRPS.
METHODS: Prospective, open label, single arm, multi-center study.
METHODS: The study was performed at the Center for Interventional Pain and Spine (Exton, PA), Millennium Pain Center (Bloomington, IL), and the Carolinas Pain Center (Huntersville, NC). It was approved by the Western Institutional Review Board-Copernicus Group Institutional Review Board and is registered at clinicaltrials.gov (NCT03954080).
METHODS: Sixteen patients with intractable chronic severe lower limb pain associated with CRPS were enrolled in the study. A standard trial period to evaluate a patients\' response to stimulation of the dorsal nerve roots was conducted over 3 to 10-days. Patients that obtained 50% or greater pain relief during the trial period underwent permanent implantation of a neurostimulation system. The primary outcome was the evaluated pain level after 3 months of device activation, based on NRS pain score relative to baseline. Patients were followed up for 6 months after activation of the permanently implanted system.
RESULTS: At the primary endpoint, patients reported a significant (P = 0.0006) reduction in pain of 3.3 points, improvement in quality of life, improved neuropathic pain characteristics, improved satisfaction, and an overall perception of improvement with the therapy. Improvements were sustained throughout the duration of the study up to the final 6-month visit.
CONCLUSIONS: Due to the COVID-19 pandemic occurring during patient enrollment, only 16 patients were enrolled and trialed, with 12 being permanently implanted. Nine were able to complete the end of study evaluation at 6 months.
CONCLUSIONS: The results of this short feasibility study confirm the functionality, effectiveness, and safety of intraspinal stimulation of dorsal nerve roots in patients with intractable chronic lower limb pain due to CRPS using commercially approved systems and conventional parameters.
OBJECTIVE: To demonstrate that electrical stimulation of dorsal nerve roots via epidural lead placement provides relief of chronic lower limb pain in patients suffering from CRPS.
METHODS: Prospective, open label, single arm, multi-center study.
METHODS: The study was performed at the Center for Interventional Pain and Spine (Exton, PA), Millennium Pain Center (Bloomington, IL), and the Carolinas Pain Center (Huntersville, NC). It was approved by the Western Institutional Review Board-Copernicus Group Institutional Review Board and is registered at clinicaltrials.gov (NCT03954080).
METHODS: Sixteen patients with intractable chronic severe lower limb pain associated with CRPS were enrolled in the study. A standard trial period to evaluate a patients\' response to stimulation of the dorsal nerve roots was conducted over 3 to 10-days. Patients that obtained 50% or greater pain relief during the trial period underwent permanent implantation of a neurostimulation system. The primary outcome was the evaluated pain level after 3 months of device activation, based on NRS pain score relative to baseline. Patients were followed up for 6 months after activation of the permanently implanted system.
RESULTS: At the primary endpoint, patients reported a significant (P = 0.0006) reduction in pain of 3.3 points, improvement in quality of life, improved neuropathic pain characteristics, improved satisfaction, and an overall perception of improvement with the therapy. Improvements were sustained throughout the duration of the study up to the final 6-month visit.
CONCLUSIONS: Due to the COVID-19 pandemic occurring during patient enrollment, only 16 patients were enrolled and trialed, with 12 being permanently implanted. Nine were able to complete the end of study evaluation at 6 months.
CONCLUSIONS: The results of this short feasibility study confirm the functionality, effectiveness, and safety of intraspinal stimulation of dorsal nerve roots in patients with intractable chronic lower limb pain due to CRPS using commercially approved systems and conventional parameters.
摘要：
背景：治疗复杂区域疼痛综合征（CRPS）的治疗选择有限。脊髓刺激和背根神经节刺激是治疗CRPS患者慢性下肢疼痛的有效疗法。有限的证据表明，刺激背神经根也可以缓解这些患者的下肢疼痛。
目的：证明通过硬膜外导联电刺激背神经根可以缓解CRPS患者的慢性下肢疼痛。
方法：前瞻性，开放标签,单臂,多中心研究。
方法：这项研究是在介入疼痛和脊柱中心进行的（Exton，PA),千年疼痛中心（布卢明顿，IL),和卡罗莱纳州疼痛中心(亨特斯维尔，NC）。它由西方机构审查委员会-哥白尼集团机构审查委员会批准，并在clinicaltrials.gov（NCT03954080）注册。
方法：本研究纳入了16例与CRPS相关的难治性慢性重度下肢疼痛患者。评估患者对背神经根刺激的反应的标准试验期为3至10天。在试验期间获得50%或更大疼痛缓解的患者接受神经刺激系统的永久性植入。主要结果是器械激活3个月后评估的疼痛水平。基于NRS相对于基线的疼痛评分。患者在永久植入系统激活后随访6个月。
结果：在主要终点，患者报告疼痛显著减少（P=0.0006）3.3分，生活质量的提高，改善神经性疼痛特征，满意度提高,以及对治疗改善的整体看法。在整个研究期间,直到最后的6个月的访问,改善持续。
结论：由于在患者招募期间发生了COVID-19大流行，只有16名患者被纳入和试验，12个被永久植入。9人能够在6个月时完成研究结束评估。
结论：这项简短的可行性研究的结果证实了功能，有效性,以及使用商业批准的系统和常规参数对由于CRPS引起的顽固性慢性下肢疼痛的患者的背侧神经根进行椎管内刺激的安全性。
目的：证明通过硬膜外导联电刺激背神经根可以缓解CRPS患者的慢性下肢疼痛。
方法：前瞻性，开放标签,单臂,多中心研究。
方法：这项研究是在介入疼痛和脊柱中心进行的（Exton，PA),千年疼痛中心（布卢明顿，IL),和卡罗莱纳州疼痛中心(亨特斯维尔，NC）。它由西方机构审查委员会-哥白尼集团机构审查委员会批准，并在clinicaltrials.gov（NCT03954080）注册。
方法：本研究纳入了16例与CRPS相关的难治性慢性重度下肢疼痛患者。评估患者对背神经根刺激的反应的标准试验期为3至10天。在试验期间获得50%或更大疼痛缓解的患者接受神经刺激系统的永久性植入。主要结果是器械激活3个月后评估的疼痛水平。基于NRS相对于基线的疼痛评分。患者在永久植入系统激活后随访6个月。
结果：在主要终点，患者报告疼痛显著减少（P=0.0006）3.3分，生活质量的提高，改善神经性疼痛特征，满意度提高,以及对治疗改善的整体看法。在整个研究期间,直到最后的6个月的访问,改善持续。
结论：由于在患者招募期间发生了COVID-19大流行，只有16名患者被纳入和试验，12个被永久植入。9人能够在6个月时完成研究结束评估。
结论：这项简短的可行性研究的结果证实了功能，有效性,以及使用商业批准的系统和常规参数对由于CRPS引起的顽固性慢性下肢疼痛的患者的背侧神经根进行椎管内刺激的安全性。
