Lefaucheur Jean-Pascal, Drouot Xavier, Cunin Patrick, Bruckert Rémy, Lepetit Hélène, Créange Alain, Wolkenstein Pierre, Maison Patrick, Keravel Yves, Nguyen Jean-Paul
Service Physiologie, Explorations Fonctionnelles, Hôpital Henri Mondor, 51 avenue de Lattre de Tassigny, Créteil Cedex, France.
Brain. 2009 Jun;132(Pt 6):1463-71. doi: 10.1093/brain/awp035. Epub 2009 Mar 31.
Epidural motor cortex stimulation (MCS) has been proposed as a treatment for chronic, drug-resistant neuropathic pain of various origins. Regarding pain syndromes due to peripheral nerve lesion, only case series have previously been reported. We present the results of the first randomized controlled trial using chronic MCS in this indication. Sixteen patients were included with pain origin as follows: trigeminal neuralgia (n = 4), brachial plexus lesion (n = 4), neurofibromatosis type-1 (n = 3), upper limb amputation (n = 2), herpes zoster ophthalmicus (n = 1), atypical orofacial pain secondary to dental extraction (n = 1) and traumatic nerve trunk transection in a lower limb (n = 1). A quadripolar lead was implanted, under radiological and electrophysiological guidance, for epidural cortical stimulation. A randomized crossover trial was performed between 1 and 3 months postoperative, during which the stimulator was alternatively switched 'on' and 'off' for 1 month, followed by an open phase during which the stimulator was switched 'on' in all patients. Clinical assessment was performed up to 1 year after implantation and was based on the following evaluations: visual analogue scale (VAS), brief pain inventory, McGill Pain questionnaire, sickness impact profile and medication quantification scale. The crossover trial included 13 patients and showed a reduction of the McGill Pain questionnaire-pain rating index (P = 0.0166, Wilcoxon test) and McGill Pain questionnaire sensory subscore (P = 0.01) when the stimulator was switched 'on' compared to the 'off-stimulation' condition. However, these differences did not persist after adjustment for multiple comparisons. In the 12 patients who completed the open study, the VAS and sickness impact profile scores varied significantly in the follow-up and were reduced at 9-12 months postoperative, compared to the preoperative baseline. At final examination, the mean rate of pain relief on VAS scores was 48% (individual results ranging from 0% to 95%) and MCS efficacy was considered as good or satisfactory in 60% of the patients. Pain relief after 1 year tended to correlate with pain scores at 1 month postoperative, but not with age, pain duration or location, preoperative pain scores or sensory-motor status. Although the results of the crossover trial were slightly negative, which may have been due to carry-over effects from the operative and immediate postoperative phases, observations made during the open trial were in favour of a real efficacy of MCS in peripheral neuropathic pain. Analgesic effects were obtained on the sensory-discriminative rather than on the affective aspect of pain. These results suggest that the indication of MCS might be extended to various types of refractory, chronic peripheral pain beyond trigeminal neuropathic pain.
硬膜外运动皮层刺激(MCS)已被提议作为治疗各种原因引起的慢性、耐药性神经性疼痛的一种方法。关于外周神经损伤所致的疼痛综合征,此前仅有病例系列报道。我们在此呈现了首例针对该适应症使用慢性MCS的随机对照试验结果。纳入了16例患者,其疼痛来源如下:三叉神经痛(n = 4)、臂丛神经损伤(n = 4)、1型神经纤维瘤病(n = 3)、上肢截肢(n = 2)、眼部带状疱疹(n = 1)、拔牙后继发的非典型口面部疼痛(n = 1)以及下肢创伤性神经干横断(n = 1)。在放射学和电生理引导下植入四极导联用于硬膜外皮层刺激。术后1至3个月进行了随机交叉试验,在此期间刺激器交替“开启”和“关闭”1个月,随后进入开放期,期间所有患者的刺激器均“开启”。植入后长达1年进行临床评估,评估基于以下内容:视觉模拟量表(VAS)、简明疼痛量表、麦吉尔疼痛问卷、疾病影响概况和药物量化量表。交叉试验纳入了13例患者,结果显示与“关闭刺激”状态相比,刺激器“开启”时麦吉尔疼痛问卷疼痛评分指数降低(P = 0.0166,威尔科克森检验)以及麦吉尔疼痛问卷感觉子评分降低(P = 0.01)。然而,在进行多重比较校正后,这些差异并未持续存在。在完成开放研究的12例患者中,VAS和疾病影响概况评分在随访中变化显著,与术前基线相比,术后9至12个月时降低。在最终检查时,VAS评分的平均疼痛缓解率为48%(个体结果范围为0%至95%),60%的患者认为MCS疗效良好或令人满意。1年后的疼痛缓解倾向于与术后1个月时的疼痛评分相关,但与年龄、疼痛持续时间或部位、术前疼痛评分或感觉运动状态无关。尽管交叉试验的结果略显阴性,这可能是由于手术期和术后即刻阶段的遗留效应所致,但开放试验期间的观察结果支持MCS在外周神经性疼痛中具有实际疗效。镇痛效果是在疼痛的感觉辨别方面而非情感方面获得的。这些结果表明,MCS的适应症可能会扩展到除三叉神经性疼痛之外的各种类型的难治性慢性外周疼痛。