Center for Pain Relief, Charleston, WV 25301, USA.
Neuromodulation. 2013 Jan-Feb;16(1):67-71; discussion 71-2. doi: 10.1111/ner.12013. Epub 2012 Dec 14.
The article aims to study the safety and effectiveness of dorsal root ganglion (DRG) stimulation with a new device in the treatment of chronic pain.
This is a prospective, single-arm, pilot study.
Four clinical centers were used as setting for this study.
Ten (10) patients with chronic intractable pain of the trunk and/or limbs were included.
A trial period of DRG stimulation was studied. Two to four leads, each with four electrical contacts, were inserted using a minimally invasive epidural approach and steered toward the lateral epidural space, near the DRG. Leads were attached to an external trial stimulator and stimulation therapy was provided for three to seven days.
Pain reduction using a visual analog scale, subject and physician-rated improvement, adverse event (AE) rates, device programming settings, and medication utilization was evaluated at baseline and at prospective follow-up time points during stimulation.
On average, there was a 70% reduction in pain following stimulation (p = 0.0007). Eight of the nine patients experienced a clinically meaningful (>30%) reduction in pain, and seven of the nine reduced their pain medication utilization. Pain relief in specific anatomical regions such as the leg, back, and foot was also observed. No device-related AEs were reported.
These initial results suggest that stimulation of the DRG can reduce pain in those patients suffering from chronic pain. DRG stimulation may offer several potential benefits over other neuromodulation techniques, including the ability to target difficult-to-reach anatomies such as the low back and foot.
本文旨在研究一种新型设备的背根神经节（DRG）刺激在慢性疼痛治疗中的安全性和有效性。
这是一项前瞻性、单臂、初步研究。
本研究使用了四个临床中心。
10 名患有躯干和/或肢体慢性难治性疼痛的患者入选。
研究了 DRG 刺激的试验期。使用微创硬膜外入路插入 2 至 4 根导联，每根导联有四个电接触点，并向侧硬膜外间隙、DRG 附近引导。导联连接到外部试验刺激器，并提供三到七天的刺激治疗。
使用视觉模拟评分法评估疼痛减轻、患者和医生评定的改善、不良事件（AE）发生率、设备编程设置和药物利用情况，在基线和刺激期间的前瞻性随访时间点进行评估。
平均而言，刺激后疼痛减轻了 70%（p = 0.0007）。9 名患者中有 8 名经历了有临床意义的（>30%）疼痛减轻，9 名患者中有 7 名减少了疼痛药物的使用。还观察到腿部、背部和脚部等特定解剖区域的疼痛缓解。未报告与设备相关的 AE。
这些初步结果表明，DRG 刺激可以减轻慢性疼痛患者的疼痛。与其他神经调节技术相比，DRG 刺激可能具有几个潜在的优势，包括能够针对难以触及的解剖结构，如腰部和脚部。
