Center for Pain Relief, Charleston, WV, USA.
Neuromodulation Institute, Boca Raton, FL, USA.
Neuromodulation. 2019 Dec;22(8):930-936. doi: 10.1111/ner.12920. Epub 2019 Jan 9.
This was a sub-analysis of the ACCURATE clinical trial that evaluated the accuracy and necessity of targeting paresthesia coverage of painful areas with dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS).
On diagrams of the torso and lower limbs, subjects marked where they felt pain at baseline and paresthesias at three months postimplant. Seventy-five subjects (41 DRG and 34 SCS) with diagrams of sufficient quality were scanned, digitized, and included in this analysis. Subject completed diagrams were digitized and superimposed with a grid of 1398 squares. Quantification of the percentage of bodily areas affected by pain and stimulation induced paresthesias was performed.
The percent of painful areas covered by paresthesia was significantly lower for DRG subjects than for SCS subjects (13% vs. 28% of the painful regions, p < 0.05), possibly because significantly more DRG subjects felt no paresthesia during stimulation when compared to SCS subjects (13/41 DRG vs. 3/34 SCS) (p < 0.05). The amount of paresthesia produced outside the painful areas (unrequired paresthesia) was significantly lower in DRG subjects than that of SCS subjects. On average, the percent of unrequired paresthesia was only 20% of the subjects' total painful body surface area in the DRG group compared to 210% in the SCS group (p < 0.01).
The results of this ACCURATE study sub-analysis show that DRG stimulation produces paresthesias, on average, that are less frequent, less intense, with a smaller footprint on the body and less dependent on positional changes.
这是 ACCURATE 临床试验的子分析,该试验评估了与持续脊髓刺激 (SCS) 相比,靶向背根神经节 (DRG) 刺激引起的感觉异常覆盖疼痛区域的准确性和必要性。
在躯干和下肢的图表上,受试者在基线时标记感到疼痛的部位和植入后三个月时的感觉异常部位。扫描了 75 名(41 名 DRG 和 34 名 SCS)具有足够质量图表的受试者,并对其进行了数字化处理,将其纳入本分析。将受试者完成的图表数字化,并与一个由 1398 个方格组成的网格叠加。对疼痛和刺激引起的感觉异常所影响的身体区域的百分比进行量化。
DRG 组感觉异常覆盖的疼痛区域百分比明显低于 SCS 组(13%对 28%的疼痛区域,p<0.05),这可能是因为与 SCS 组相比,DRG 组在刺激时感觉不到感觉异常的受试者明显更多(DRG:13/41 对 SCS:3/34)(p<0.05)。在疼痛区域之外产生的感觉异常(不必要的感觉异常)量在 DRG 组明显低于 SCS 组。平均而言,DRG 组中不必要的感觉异常百分比仅为受试者总疼痛体表面积的 20%,而 SCS 组为 210%(p<0.01)。
这项 ACCURATE 研究的子分析结果表明,DRG 刺激产生的感觉异常平均频率较低、强度较弱、对身体的影响范围较小,且对体位变化的依赖性较小。