Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 40
- 主要终点
- Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
研究概览
简要总结
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- •Presence of low back and leg pain
- •Moderate to crippled disability due to pain
- •Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- •Willing and able to not increase pain medications through the 3-Month visit
排除标准
- •Previously trialed or implanted with stimulator or intrathecal drug delivery system
- •Current diagnosis of moderate to severe central lumbar spinal stenosis
- •Major psychiatric comorbidity or other progressive diseases
- •Serious drug-related behavioral issues
- •Pregnant or planning on becoming pregnant
- •Unable to achieve supine position
结局指标
主要结局
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
时间窗: Baseline to 3 months
Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study.
次要结局
- Overall Pain Efficacy Responder Rate(Baseline to 3 months)
- Leg Pain Efficacy Responder Rate(Baseline to 3 months)
- Low Back Pain Efficacy Responder Rate(Baseline to 3 months)