Effectiveness and Safety of Implantable Intrathecal Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (INTRATHECAL-RENASED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 504
- 试验地点
- 9
- 主要终点
- Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year
研究概览
简要总结
Refractory pain is a prevalent condition that negatively affects patients' quality of life. Intrathecal implantable systems have been proposed as a treatment option for refractory pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of intrathecal implantable systems for refractory pain treatment in Spain.
详细描述
All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to participate in the study. Patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. Demographic data related to the pathology and procedure will be collected. Follow-up will be conducted at three and twelve months after the procedure.
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
- •Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
- •Accept to participate in the study and sign informed consent.
排除标准
- •Patients in whom it would be difficult to complete follow-up.
- •Insufficient understanding of the Spanish language.
- •Pregnancy.
结局指标
主要结局
Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year
时间窗: Twelve months
Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)
次要结局
- Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months(Three months)
- Compared change from baseline on health-related quality of life scores (EQ Index)(Three and twelve months)
- Patient Satisfaction(Three and twelve months)
- Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year(Twelve months)
- Patient Global Impression of Improvement (PGI-I)(Three and twelve months)
- Number of Adverse Events as a Measure of Safety(Three and twelve months)