Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.
研究概览
简要总结
Assessing the long-term efficacy, complications, revision rates and final explantation of the device
详细描述
Longitudinal study with a follow-up of 2 years in patients implanted with the Precision neurostimulator.
This study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)
排除标准
- •Refusal of patient
- •Patient whose long-term monitoring will not be possible
结局指标
主要结局
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.
时间窗: From baseline until the end of the study at 24 months.
Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.
时间窗: From baseline until the end of the study at 24 months.
The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.
次要结局
- Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale(From baseline until the end of the study at 24 months)
- Patients' Opinion on the Evolution of Pain(From baseline until the end of the study at 24 months)
- Evolution of Quality of Life (SF-12) - Physical Score(From baseline until the end of the study at 24 months)
- Percentage of Patients With Anxiety and Depression Disorders(From baseline until the end of the study at 24 months)
- Patients' Willingness to Restart the Treatment(From baseline until the end of the study at 24 months)
- Evolution of Quality of Life (SF-12) - Mental Score(From baseline until the end of the study at 24 months)
- Evolution of the Use of Level 3 Analgesics(From baseline until the end of the study at 24 months)
- Evolution of the Use of Other Pain Treatments(From baseline until the end of the study at 24 months)