Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AZ Delta
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- caregiver strain index
研究概览
简要总结
Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.
详细描述
Spinal cord stimulation is an effective therapy for chronic neuropathic pain. After careful selection, the satisfaction for the patient is often considerable. The investigators want to investigate the caregiver burden for relatives of patients who are treated with spinal cord stimulation. This will be evaluated by appropriate scores at baseline, during neurostimulator trial and 3,6 and 12 months after implantation. At the same time the patient satisfaction and pain reduction will also be evaluated independently.
In this prospective cohort different parameters will be assessed at baseline, trial, 3, 6 and 12 months follow-up for the patient and their caregiver.
For the patient this will include Numeric Rating scale (NRS) for leg and back pain, Oswestry Disability Index (ODI), EuroQuality of Life-5 Dimensions score (EQ5D), opiate use and Relation Quality Index (RQI).
For the caregiver the Zarit Burden Index (ZBI), Relation Quality Index (RQI) and Modified Caregiver Strain Index (MCSI).
With regard to the research questions, subgroup analysis will be performed regarding to age, sex, education, neurostimulation pattern, surgical vs percutaneous lead placement, working status of both patient and caregiver and caregiver relation characteristics.
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
- •Patients Age > 18 years
- •Patients with an identified spousal or offspring caregiver
- •Patients receiving neurostimulator for the first time
- •Patient complies to reimbursement criteria for spinal cord stimulation in Belgium
排除标准
- •Non-spinal cord type of neuromodulation (DRG, occipital, peripheral nerve, )
- •Revision cases, previous neuromodulation
- •Patients unable to consent for this study
- •Patients without identified spousal or offspring caregiver
结局指标
主要结局
caregiver strain index
时间窗: baseline to 12 months
Zarit Burden index
时间窗: baseline to 12 months
Zarit Burden index measures the burden of a caregiver in 12 questions
relation quality index caregiver
时间窗: baseline to 12 months
次要结局
- Oswestry Disability Index(baseline to 12 months)
- NRS pain leg and back(baseline to 12 months)
- EuroQol five dimensions EQ-5D(baseline to 12 months)
- relation quality index patient(baseline to 12 months)
- analgetics dose(baseline to 12 months)