De Jaeger Mats, van Hooff Robbert-Jan, Goudman Lisa, Valenzuela Espinoza Alexis, Brouns Raf, Puylaert Martine, Duyvendak Wim, Moens Maarten
Department of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium.
Department of Radiology, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium.
Anesth Pain Med. 2017 May 30;7(3):e13640. doi: 10.5812/aapm.13640. eCollection 2017 Jun.
Spinal cord stimulation (SCS) is a proven and effective treatment for neuropathic pain conditions such as failed back surgery syndrome (FBSS). The hypothesis that different settings for SCS parameters activate unique, pain-relieving mechanisms has boosted the development of various SCS paradigms. High density spinal cord stimulation (HD-SCS) is one of those promising, novel stimulation forms characterized by subthreshold stimulation, delivering more pulses per second and a higher pulse density to the spinal cord than conventional SCS.
The aim of DISCOVER is to gather evidence about the effectiveness, feasibility, and (possible) side effects of HD stimulation.
The prospective, non-interventional, multi-center, clinical study, DISCOVER, is currently restricted to Belgium where 19 neuromodulation centers were selected. Patient recruitment started in October 2016 and is expected to end in October 2017. Subjects included are (1) patients with insufficient pain relief from conventional SCS or (2) neurostimulation-naïve patients suited for SCS. Patients will be assessed 1 month, 3 months, and 12 months after conversion to HD-SCS settings. Each patient's visit will include: a numerical rating scale (NRS), Oswestry disability index (ODI), Pittsburgh sleep quality index (PSQI), EQ-5D, a pain map, registration of SCS settings, and a list of used pain medication.
Although promising results have been reported, adequate registration of its effectiveness and (possible) side-effects remains an unmet need. Main results are expected in 2019.
脊髓刺激（SCS）是治疗诸如腰椎手术失败综合征（FBSS）等神经性疼痛疾病的一种经证实有效的疗法。不同SCS参数设置激活独特的止痛机制这一假说推动了各种SCS模式的发展。高密度脊髓刺激（HD-SCS）是那些有前景的新型刺激形式之一，其特点是阈下刺激，每秒向脊髓传递更多脉冲且脉冲密度高于传统SCS。
DISCOVER研究的目的是收集关于HD刺激的有效性、可行性及（可能的）副作用的证据。
前瞻性、非干预性、多中心临床研究DISCOVER目前仅限于比利时，在该国选择了19个神经调节中心。患者招募于2016年10月开始，预计于2017年10月结束。纳入的受试者为：（1）传统SCS止痛效果不佳的患者或（2）适合SCS但未接受过神经刺激治疗的患者。患者在转换为HD-SCS设置后1个月、3个月和12个月将接受评估。每位患者的访视将包括：数字评分量表（NRS）、Oswestry功能障碍指数（ODI）、匹兹堡睡眠质量指数（PSQI）、EQ-5D、疼痛图谱、SCS设置记录以及所用止痛药物清单。
尽管已有报道称取得了有前景的结果，但对其有效性和（可能的）副作用进行充分记录仍是一项未满足的需求。预计2019年得出主要结果。
