NCT01778426已完成不适用
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
研究概览
简要总结
Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.
This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.
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
- 否
入选标准
- •Patient indicated for Spinal Cord Stimulation (pain therapy)
- •Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
- •primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
- •device replacement of a Medtronic neurostimulator used for Pain Therapy
- •Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.
- •Treatments must also be available
- •Patient read and signed the data release form
排除标准
- •Patient declined participation
- •Patient is not available for follow up
- •Stimulation of other body part than spinal
结局指标
主要结局
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
时间窗: 2 years
Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).
次要结局
- Dose of Analgesics Level 3 (Morphinics)(Baseline, 1 and 2 years)
- Return to Work(1 and 2 years)
- Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year(1 year)
- Patient Satisfaction(1 and 2 years)
- Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain(1 year and 2 years)
- Concomitant Pain Relief Medication(Baseline, 1 and 2 years)
研究者
研究点 (1)
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