Kloimstein Herwig, Likar Rudolf, Kern Michael, Neuhold Josef, Cada Miroslav, Loinig Nadja, Ilias Wilfried, Freundl Brigitta, Binder Heinrich, Wolf Andreas, Dorn Christian, Mozes-Balla Eva Maria, Stein Rolf, Lappe Ivo, Sator-Katzenschlager Sabine
Department of Anaesthesiology, Intensive Care and Pain Medicine, Wilhelminenspital der Stadt Wien, Vienna, Austria.
Neuromodulation. 2014 Feb;17(2):180-7. doi: 10.1111/ner.12139. Epub 2013 Dec 9.
The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP).
In this prospective, multicenter observational study, 118 patients were admitted to 11 centers throughout Austria and Switzerland. After a screening visit, all patients underwent a trial stimulation period of at least seven days before implantation of the permanent system. Leads were placed in the subcutaneous tissues of the lower back directly in the region of greatest pain. One hundred five patients were implanted with a permanent stimulating system. Patients' evaluation of pain and functional levels were completed before implantation and one, three, and six months after implantation. Adverse events, medication usage, and coverage of the painful area and predictive value of transcutaneous electrical nerve stimulation (TENS) were monitored.
All pain and quality-of-life measures showed statistically significant improvement during the treatment period. These included the average pain visual analog scale, the Oswestry Disability Questionnaire, the Becks Depression Inventory, and the Short Form-12 item Health survey. Additionally, medication usage with opioids, nonsteroidal anti-inflammatory drugs, and anti-convulsants showed a highly significant reduction. Complications requiring surgical intervention were reported in 9.6% of the patients. The degree of coverage of painful areas seems to be an important criterion for efficacy of PNFS, whereas TENS is presumably no predictor.
This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal.
本研究的目的是评估周围神经场刺激（PNFS）治疗慢性下腰痛（cLBP）的长期疗效和安全性。
在这项前瞻性、多中心观察性研究中，118名患者被纳入奥地利和瑞士的11个中心。在进行筛选访视后，所有患者在植入永久性系统前均接受了至少7天的试验刺激期。电极直接放置在腰部疼痛最严重区域的皮下组织中。105名患者植入了永久性刺激系统。在植入前以及植入后1个月、3个月和6个月完成患者对疼痛和功能水平的评估。监测不良事件、药物使用情况、疼痛区域覆盖情况以及经皮电刺激神经疗法（TENS）的预测价值。
在治疗期间，所有疼痛和生活质量指标均显示出具有统计学意义的改善。这些指标包括平均疼痛视觉模拟量表、奥斯威斯功能障碍问卷、贝克抑郁量表以及简短健康调查问卷（SF-12）。此外，阿片类药物、非甾体抗炎药和抗惊厥药的使用量显著减少。9.6%的患者报告了需要手术干预的并发症。疼痛区域的覆盖程度似乎是PNFS疗效的一个重要标准，而TENS可能不是一个预测指标。
这项前瞻性、多中心研究证实，PNFS是治疗cLBP的有效疗法。在疼痛状况的许多方面都有显著改善，且并发症极少。
