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外周神经刺激试验的新技术:超声引导下的StimuCath试验

Novel technique for trialing peripheral nerve stimulation: ultrasonography-guided StimuCath trial.

作者信息

Reddy Chandan G, Flouty Oliver E, Holland Marshall T, Rettenmaier Leigh A, Zanaty Mario, Elahi Foad

机构信息

Departments of 1 Neurosurgery and.

University of Iowa Carver College of Medicine, Iowa City, Iowa.

出版信息

Neurosurg Focus. 2017 Mar;42(3):E5. doi: 10.3171/2016.12.FOCUS16475.

Abstract

OBJECTIVE Peripheral nerve stimulation (PNS) has been used for the treatment of neuropathic pain for many decades. Despite the specific indications for PNS, clinicians often have difficulty screening for candidates likely to have a good or fair outcome. Given the expense of a permanent implant, most insurance companies will not pay for the implant without a successful PNS trial. And since PNS has only recently been approved by the US Food and Drug Administration, many insurance companies will not pay for a conventional trial of PNS. The objective of this study is to describe a short low-cost method for trialing and screening patients for peripheral nerve stimulator implantation. Additionally, this study demonstrates the long-term efficacy of PNS in the treatment of chronic neuropathic pain and the relative effectiveness of this novel screening method. METHODS The records of all patients who had undergone trialing and implantation of a PNS system for chronic refractory pain at the authors' institution over a 1-year period (August 1, 2012-July 31, 2013) were examined in this retrospective case series. The search revealed 17 patients, 13 who had undergone a novel in-office ultrasonography-guided StimuCath screening technique and 4 who had undergone a traditional week-long screening procedure. All 17 patients experienced a successful PNS trial and proceeded to permanent PNS system implantation. Patients were followed up for a mean duration of 3.0 years. Visual analog scale (VAS) pain scores were used to assess pain relief in the short-term (< 6 weeks), at 1 year, and at the last follow-up. Final outcome was also characterized as good, fair, poor, or bad. RESULTS Of these 17 patients, 10 were still using their stimulator at the last follow-up, with 8 of them obtaining good relief (classified as ≥ 50% pain relief, with an average 81% reduction in the VAS score) and 2 patients attaining fair relief (< 50% relief but still using stimulation therapy). Among the remaining 7 patients, the stimulator had been explanted in 4 and there had been no relief in 3. Excluding explanted cases, follow-up ranged from 14 to 46 months, with an average of 36 months. Patients with good or fair relief had experienced pain prior to implantation for an average of 5.1 years (range 1.8-15.2 years). A longer duration of pain trended toward a poorer outcome (bad outcome 7.6 years vs good outcome 4.1 years, p = 0.03). Seven (54%) of the 13 patients with the shorter trial experienced a good or fair outcome with an average 79% reduction in the VAS score; however, all 4 of the bad outcome cases came from this group. Three (75%) of the 4 patients with the longer trial experienced a good or fair outcome at the last follow-up, with an average 54% reduction in the VAS score. There was no difference between the trialing methods and the proportion of favorable (good or fair) outcomes (p = 0.71). CONCLUSIONS Short, ultrasonography-guided StimuCath trials were feasible in screening patients for permanent implantation of PNS, with efficacy similar to the traditional week-long screening noted at the 3-year follow-up.

摘要

目的 外周神经刺激(PNS)已用于治疗神经性疼痛数十年。尽管PNS有特定的适应症,但临床医生在筛选可能有良好或中等效果的患者时往往存在困难。鉴于永久性植入物的费用,大多数保险公司在PNS试验未成功的情况下不会支付植入费用。而且由于PNS最近才获得美国食品药品监督管理局的批准,许多保险公司不会为PNS的传统试验付费。本研究的目的是描述一种用于试验和筛选外周神经刺激器植入患者的简短低成本方法。此外,本研究证明了PNS治疗慢性神经性疼痛的长期疗效以及这种新型筛选方法的相对有效性。

方法 在这个回顾性病例系列中,检查了作者所在机构在1年期间(2012年8月1日至2013年7月31日)接受PNS系统试验和植入治疗慢性难治性疼痛的所有患者的记录。检索发现17例患者,其中13例接受了新型的办公室超声引导下的StimuCath筛选技术,4例接受了传统的为期一周的筛选程序。所有17例患者的PNS试验均成功,并进行了永久性PNS系统植入。对患者进行了平均3.0年的随访。使用视觉模拟量表(VAS)疼痛评分评估短期(<6周)、1年和最后一次随访时的疼痛缓解情况。最终结果也分为良好、中等、差或不良。

结果 在这17例患者中,10例在最后一次随访时仍在使用刺激器,其中8例获得了良好的缓解(定义为疼痛缓解≥50%,VAS评分平均降低81%),2例获得了中等缓解(缓解<50%但仍使用刺激疗法)。其余7例患者中,4例已取出刺激器,3例未缓解。排除取出刺激器的病例后,随访时间为14至46个月,平均36个月。缓解良好或中等的患者植入前疼痛平均持续时间为5.1年(范围1.8 - 15.2年)。疼痛持续时间越长,预后越差的趋势越明显(不良预后7.6年 vs 良好预后4.1年,p = 0.03)。13例试验时间较短的患者中有7例(54%)获得了良好或中等的结果,VAS评分平均降低79%;然而,所有4例不良预后病例均来自该组。4例试验时间较长的患者中有3例(75%)在最后一次随访时获得了良好或中等的结果,VAS评分平均降低54%。试验方法与良好(或中等)结果的比例之间没有差异(p = 0.71)。

结论 简短的超声引导下的StimuCath试验对于筛选PNS永久性植入患者是可行的,其疗效与3年随访时记录的传统为期一周的筛选相似。

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