Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in pain relief
研究概览
简要总结
The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.
详细描述
This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors
排除标准
- 未提供
结局指标
主要结局
Change in pain relief
时间窗: 12 months
Percent of patient who show a change in Pain Scale (PIPS) \>50% at the end of follow up period of 12 months
次要结局
未报告次要终点