Effectiveness and Safety of Implantable Neurostimulation Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (STIM-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
- 16
- 主要终点
- Percentage of patients with at least 50 % pain relief in the area of their predominant pain at one year.
研究概览
简要总结
Chronic pain is a prevalent condition that negatively affects patients' quality of life. Implantable neurostimulation therapies have been proposed as a treatment option for chronic 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 implantable stimulation systems for chronic pain treatment in Spain.
详细描述
All Spanish hospitals that implant neurostimulation systems for pain treatment 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 six 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 % 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% in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the neurostimulation 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
- Patient Satisfaction(Six and twelve months)
- Compared change from baseline on health-related quality of life scores (EQ Index)(Six and twelve months)
- Patient Global Impression of Improvement(Six and twelve months)
- Percentage of patients with at least 50 % pain relief in the area of their predominant pain at six months.(Six months)
- Percentage of patients with at least 50 % pain relief in the area of their non-predominant pain at one year.(Six and twelve months)
- Number of Adverse Events as a Measure of Safety(Six and twelve months)