Billet B, Hanssens K, De Coster O, Nagels W, Weiner R L, Wynendaele R, Vanquathem N
AZ Delta, Roeselare, Belgium.
Presbyterian Hospital, Dallas, University of Texas Southwestern Medical School, Dallas, TX, USA.
Acta Anaesthesiol Scand. 2018 Sep;62(8):1133-1138. doi: 10.1111/aas.13138. Epub 2018 Apr 19.
Evaluation of the efficacy of a wireless high-frequency stimulator placed over selected DRG of exiting nerve roots for the treatment of chronic low back pain.
Feasibility.
Six subjects with chronic, intractable back pain refractory to standard medical treatment.
Four stimulators (Freedom-4A) provided by Stimwave Technologies, were implanted over the DRG exiting nerve roots, bilaterally at both the T9 and L2 vertebral levels. Subjects were asked to evaluate stimulation independently with the devices turned on at T9 and subsequently L2 for each of 2 weeks. Subjects were then monitored for 8 weeks with the preferred stimulator. Pain reduction with the Visual Analog Scale (VAS), functionality with the Oswestry Disability Index (ODI), Patient Global Impression of Change (PGIC) and medication usage were evaluated.
Four subjects preferred T9 stimulation with only one subject preferring stimulation at L2. One subject dropped out of the study before conclusion of the 4-week evaluation and is not included in this report. Average pain levels (n = 5) at 12-week post-implantation decreased with 61% for back pain and 56% for leg pain with a significant reduction in pain medication, including a 100% reduction in opioid pain medications. The average reduction in disability was 12%. Subjects reported an average impression of change of 6 (1 = no change, 7 = great deal better).
Wireless high-frequency stimulation of the DRG is a viable option to treat chronic low back pain. Preliminary results show a subject preference for stimulation at the T9 vertebral level.
评估将无线高频刺激器置于出神经根的选定背根神经节上方治疗慢性下腰痛的疗效。
可行性研究。
6名患有慢性顽固性背痛且对标准药物治疗无效的受试者。
由Stimwave Technologies公司提供的4个刺激器（Freedom-4A），被植入T9和L2椎体水平双侧的出神经根背根神经节上方。要求受试者在T9和随后的L2分别开启设备独立评估刺激情况，每次持续2周。然后使用受试者偏好的刺激器对其进行8周监测。评估视觉模拟量表（VAS）的疼痛减轻情况、奥斯维斯特里功能障碍指数（ODI）的功能状况、患者总体变化印象（PGIC）以及药物使用情况。
4名受试者偏好T9刺激，只有1名受试者偏好L2刺激。1名受试者在4周评估结束前退出研究，本报告未纳入该受试者。植入后12周时，5名受试者的背痛平均水平下降了61%，腿痛平均水平下降了56%，止痛药物显著减少，其中阿片类止痛药物减少了100%。残疾平均减少了12%。受试者报告平均变化印象为6分（1分=无变化，7分=改善很多）。
对背根神经节进行无线高频刺激是治疗慢性下腰痛的一种可行选择。初步结果显示受试者更倾向于T9椎体水平的刺激。
