Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
研究概览
简要总结
Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.
A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).
Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.
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
- •Age ≥ 18 years
- •With neuropathic pain:
- •confirmed (DN4 score> 4/10)
- •going back to one year at least
- •refractory to well-conducted medical treatments
- •Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)
- •Having given his non-opposition
排除标准
- •Patient with sepsis
- •Having no well-conducted prior medical treatment
- •With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe depression)
- •with somatoform disorders
- •addicted to alcohol or drugs or withdrawal syndrome
- •Deprived of liberty or under guardianship.
结局指标
主要结局
Efficacy of spinal cord stimulation on the various symptoms of neuropathic pain using the Neuropathic Pain Symptom Inventory (NPSI), change is being assessed.
时间窗: Day 0; Day 7 after surgery; 3 months, 6 months and 12 months after surgery
Neuropathic pain score obtained by the NPSI questionnaire
次要结局
- Efficacy of spinal cord stimulation on the psychological level (anxiety and depression)(Day 0 and 12 months after surgery)
- Efficacy of spinal cord stimulation on quality of life.(Day 0 and 12 months after surgery)