NCT03761316已完成不适用
Goal Setting in SCS Patients: a Qualitative Review (LEISURE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Goals and expectations towards spinal cord stimulation
研究概览
简要总结
This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- •FBSS patients suitable for SCS
- •Age > 18 years
- •Native Dutch or French speeking patients
排除标准
- •Expected inability of patients to receive or properly operate the spinal cord stimulation system
- •History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- •Active malignancy
- •Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- •Immune deficiency (HIV positive, immunosuppressiva, etc.)
- •Life expectancy < 1 year
- •Local infection or other skin disorder at site of incision
- •Pregnancy
- •Other implanted active medical device
结局指标
主要结局
Goals and expectations towards spinal cord stimulation
时间窗: Before spinal cord stimulation implantation
Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview
次要结局
未报告次要终点
研究者
Moens Maarten
Prof. dr.
Universitair Ziekenhuis Brussel
研究点 (1)
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