Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain: Study Protocol for a Prospective, Multicentric Observational Study (the PROSTIM Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Back pain
研究概览
简要总结
The PROSTIM study is an ongoing prospective, multicentric and observational clinical study. Patients are recruited in three different centers in Eastern Belgium from May 2018 onwards. This real-world data collection approaches the outcome assessment of daily medical practice. A hierarchical cluster analysis is used to identify significant patient clusters based on the Visual Analogue Scale (VAS), Oswestry disability index (ODI), Pain Vigilance and Awareness Questionnaire (PVAQ), Pain Catastrophizing Scale (PCS) and EuroQol with five dimensions for health-related quality of life (EQ-5D). Patient clusters will be assessed on the change in biopsychosocial variables after six weeks, three and twelve months. Secondary outcomes include the comparison of pain medication use, SCS parameters, treatment satisfaction and return to work.
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
- •Male/female over 18 years old.
- •Chronic intractable back and/or leg pain (PSPS T2), refractory to conservative treatment measures.
- •Positive recommendation after multidisciplinary assessment including psychiatric assessment.
- •Patients are capable of giving written informed consent.
排除标准
- •Negative recommendation after multidisciplinary assessment (ex. psychiatric disorders).
- •Insufficient improvement during trial period.
- •Previous SCS implantation.
- •Removal due to complication (infection, loss of function,...)
- •Surgical contraindication (infection of surgical site, coagulation disorders,..)
- •Pregnancy.
结局指标
主要结局
Back pain
时间窗: 12 months
Visual analogue scale back (0-10)
Disability
时间窗: 12 months
Oswestry Disability Index, ODI (0-100)
Leg pain
时间窗: 12 months
Visual analogue scale back (0-10)
Health-related quality of life
时间窗: 12 months
EQ-5D-3L
次要结局
- Spinal cord stimulation type(12 months)
- Satisfied with current treatment(12 months)
- Rate of return to work(12 months)
- Pain medication(12 months)
研究者
Mark Plazier
Prof. Dr. Plazier
Studie- & Opleidingscentrum Neurochirurgie Virga Jesse