Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
研究概览
简要总结
The goal of this interventional study is to learn if dorsolateral spinal cord stimulation (DL-SCS) can treat focal post-surgical, medically refractory neuropathic pain. The main question it aims to answer is:
- How does DL-SCS compare to traditional SCS and no treatment for treating post-surgical neuropathic pain?
Participants will be asked to
- trial combinations of stimulation across blocks of weeks (randomized cross-over)
- rate their pain after each stimulation trial
详细描述
Neuropathic pain resulting from injury to the somatosensory nervous system can be a persistent and debilitating condition of spontaneous and unprovoked symptoms. For patients with chronic neuropathic pain that does not respond to conservative therapy, spinal cord stimulation (SCS) may be considered. SCS has been established as an effective and sustained treatment for neuropathic pain, but may deliver treatment to more than just the pain area. Dorsolateral spinal cord stimulation (DL-SCS) may provide a more focal alternate target for spinal stimulation. The aim of this study is to investigate DL-SCS as a therapeutic option for post-surgical, medically refractory neuropathic pain. This is a prospective, randomized, double-blind controlled crossover trial to investigate the efficacy of DL-SCS and midline SCS (M-SCS) compared to sham stimulation for the diagnosis of post-surgical neuropathic pain. Each participant will be implanted with two electrodes and will crossover into each stimulation program in a randomized order to serve as their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
时间窗: Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery
The primary outcome is the self-reported difference in change from baseline of the severity of pain quantified in the Numerical Rating Scale. This will be assessed at baseline (pre-surgery) and at regular follow-up appointments.
次要结局
- Change in score on the Brief Pain Inventory Short Form(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on Oswestry Disability Index(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on EuroQol 5 Dimension Questionnaire(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in score on the 12-item Short Form Survey(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
- Change in morphine equivalents used(Baseline and at 4, 6, 8, 10, 52, 104 weeks post-surgery)
研究者
Lutz Weise
Principal Investigator
Nova Scotia Health Authority