AdaptiveStim Objectifying Subjective Pain Questionnaires
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Disability
研究概览
简要总结
This is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the AdaptiveStim accelerometer output.
详细描述
The aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted IPG (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.
The main focus of this study is to explore the relationship between the subjective reporting of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain intensity with the NRS-diary and the objective measurement of functional positions with the AdaptiveStim in patients receiving high density spinal cord stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month)
- •Age > 18 years
排除标准
- •Patients with Parkinson's disease
- •Patients immobilised due to limb/pelvis/costal fractures
- •Stroke patients with MRS>3
研究组 & 干预措施
spinal cord stimulation(RestoreSensor)
干预措施: registration of AdaptiveStim (Other)
结局指标
主要结局
Disability
时间窗: Disability will be measured at the second assessment namely 7 days after the first assessment
Disability will be measured using the Oswestry Disability Index (ODI) questionnaire
AdaptiveStim output
时间窗: The change between baseline (T1) and the second assessment 7 days later (T1+7days)
The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.
次要结局
- Numeric Rating Scale (NRS) pain diary(Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days)))
- Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).(Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days)))
- Subjective sleep quality(Disability will be measured at the second assessment namely 7 days after the first assessment)
研究者
Moens Maarten
Prof. dr.
Universitair Ziekenhuis Brussel