Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)
Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)
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DOI：
10.1186/s13063-020-04587-6
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发表时间：
2020-08-03
期刊：
影响因子：
2.5
通讯作者：
Rigoard, Philippe
中科院分区：
文献类型：
--
作者：
Billot, Maxime;Naiditch, Nicolas;Rigoard, Philippe
背景：虽然技术的发展为在背部手术失败综合征(FBSS)患者中使用不同波形的脊髓刺激治疗慢性顽固性疼痛提供了新的机会，但到目前为止还没有随机对照试验来比较这些不同刺激波形的疗效。MULTIWAVE是一项前瞻性、随机、双盲、交叉试验研究，旨在比较传统紧张性刺激(TCS)、突发刺激(Burst)和高频刺激(HF)在15个月期间对植入SCS患者的FBSS患者的临床疗效。方法/设计：28名患者将在法国的Poitiers大学医院、Niort和La Rochelle医院招募。符合条件的下腰腿痛患者术后腰腿痛的视觉模拟评分(VAS；)平均为5分，他们被植入并随机分配到六个手臂中的一个(以1：1：1：1：1：1的比率)，在那里他们接受为期3个月的TCS、Burst和HF的组合，包括每月一种治疗方式，并在六种可能的组合中改变接受方式的顺序。接受鞘内给药、周围神经刺激和背部再手术的患者与最初的背痛主诉和实验治疗相关，不包括在本研究中。脊髓刺激组的患者接受试探性刺激，所有患者都接受为期2个月的TCS治疗，作为金标准模式。此后，患者被随机分配到六个组中的一个组，总持续时间为3个月。然后，患者在12个月的随访期内选择他们喜欢的刺激方式(TCS、Burst或HF)。结果评估在基线(首次植入)、随机化前(基线后2个月)以及随机化后1、2、3、6、9和15个月进行。我们的主要结果是从基线到每个刺激期之后的5天疼痛日记期间的平均全球疼痛VAS。其他结果包括腿部和背部疼痛强度、功能残疾、生活质量、心理状态、感觉异常强度、患者满意度和不良事件数量的变化。讨论：招募始于2017年2月，将持续到2019年。
Background: While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no randomized controlled trial available to compare the efficacy of these different stimulations waveforms to date. MULTIWAVE is a prospective, randomized, double-blinded, crossover trial study designed to compare the clinical efficacy of tonic conventional stimulation (TCS), burst stimulation (BURST) and high-frequency stimulation (HF) in FBSS patients over a 15-month period in SCS implanted patients.Methods/design: Twenty-eight patients will be recruited in the Poitiers University Hospital, in Niort and La Rochelle Hospitals in France. Eligible patients with post-operative low back and leg pain with an average visual analog scale (VAS) score >= 5 for low back pain are implanted and randomly assigned to one of the six arms (in a 1:1:1:1:1:1 ratio), where they receive a 3-month combination of TCS, BURST and HF including one treatment modality per month and varying the order of the modality received within the six possible combinations. Patients receiving intrathecal drug delivery, peripheral nerve stimulation and back resurgery related to the original back pain complaint and experimental therapies are excluded from this study. Patients included in the spinal cord stimulation group undergo trial stimulation, and they all receive a TCS treatment for 2 months, as the gold standard modality. Thereafter, patients are randomly assigned to one of the six arms for the total duration of 3-month crossover period. Then, patients choose their preferred stimulation modality (TCS, BURST, or HF) for the follow-up period of 12 months. Outcome assessments are performed at baseline (first implant), before randomization (2 months after baseline) and at 1, 2, 3, 6, 9 and 15 months post-randomization. Our primary outcome is the average global VAS of pain over 5-day pain diary period between baseline and after each period of stimulation. Additional outcomes include changes in leg and back pain intensity, functional disability, quality of life, psychological state, paraesthesia intensity perception, patient satisfaction and the number of adverse events.Discussion: Recruitment began in February 2017 and will continue through 2019.