Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (Pain)
研究概览
简要总结
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
详细描述
Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •spinal cord stimulator implant within last 3 weeks
- •at least 22 years old
- •patients who agree not to add or increase their pain medications during the study
排除标准
- •patients with prior spinal cord stimulators
- •pregnancy
- •infusion pump
- •history of substance abuse or dependency in last 6 months
结局指标
主要结局
Numeric Rating Scale (Pain)
时间窗: Weeks 4, 6 and 8
0 (no pain)- 10 (worst pain imaginable)
次要结局
- Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.(weeks 4, 6, and 8)
研究者
Eugene Mironer, M.D.
PI
Carolinas Center for Advanced Management of Pain