PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.
Pain Clinic, Nord-Deux-Sèvres Hospital Center, Thouars, France.
Trials. 2020 Aug 3;21(1):696. doi: 10.1186/s13063-020-04587-6.
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.
Recruitment began in February 2017 and will continue through 2019.
Clinicaltrials.gov NCT03014583 . Registered on 9 January 2017.
虽然技术的发展为使用不同脊髓刺激波形模式治疗失败性腰椎手术综合征（FBSS）的慢性难治性疼痛提供了新的机会，但迄今为止，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，旨在比较在 15 个月的时间内，FBSS 患者中经皮脊髓电刺激（SCS）植入后强直常规刺激（TCS）、爆发刺激（BURST）和高频刺激（HF）的临床疗效。
方法/设计：28 名患者将在法国普瓦捷大学医院、尼奥尔和拉罗谢尔医院招募。纳入标准为术后腰痛伴腿痛，平均视觉模拟评分（VAS）≥5 分的患者植入 SCS，并随机分为 6 组（1:1:1:1:1:1 比例），每组接受 3 个月的 TCS、BURST 和 HF 联合治疗，每月接受一种治疗模式，并在 6 种可能的组合中改变接受模式的顺序。接受鞘内药物输送、周围神经刺激和与原腰痛投诉相关的后路手术以及实验性治疗的患者被排除在本研究之外。纳入 SCS 组的患者接受试验性刺激，所有患者均接受 2 个月的 TCS 治疗，作为金标准模式。此后，患者随机分配至 6 组中的一组进行 3 个月的交叉期。然后，患者选择他们喜欢的刺激模式（TCS、BURST 或 HF）进行 12 个月的随访期。在基线（首次植入）、随机分组前（基线后 2 个月）和随机分组后 1、2、3、6、9 和 15 个月进行结果评估。我们的主要结果是在基线和每次刺激期之间的 5 天疼痛日记期间疼痛的平均总体 VAS。其他结果包括腿部和背部疼痛强度、功能障碍、生活质量、心理状态、感觉异常强度感知、患者满意度和不良事件的变化。
招募工作于 2017 年 2 月开始，将持续到 2019 年。
Clinicaltrials.gov NCT03014583。2017 年 1 月 9 日注册。
