Evaluation of Physiological Parameters in Patients With Complex Regional Pain Syndrome of the Lower Limbs Treated With Dorsal Root Ganglion Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AZ Delta
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
- Objective and Rationale: The study seeks to evaluate how Dorsal Root Ganglion Stimulation (DRGS) influences autonomic functions in patients suffering from Complex Regional Pain Syndrome type I (CRPS I), offering new metrics beyond pain scores to assess therapeutic efficacy.
- Innovative Approach: Continuous monitoring of patients using validated, CE-marked biosensors (Corsano Biosensor and Motionwatch8) to collect real-time physiological data during active DRGS therapy and therapy cessation periods.
- Clinical Impact: Results from this study may improve patient management strategies and refine treatment protocols for individuals living with CRPS I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Complex Regional Pain Syndrome Type I (CRPS I) of the lower limbs.
- •Currently treated with Dorsal Root Ganglion Stimulation (DRGS).
- •Patients must experience > 50% pain relief with DRGS therapy for at least three months.
- •Willingness and ability to comply with the study requirements, including wearing biosensors, and sharing their physiological parameters.
排除标准
- •Refusal or inability to wear biosensor wearables.
- •Current pregnancy.
- •Patients with other significant medical conditions that could affect autonomic function.
- •Known allergies or intolerance to materials used in biosensors.
- •Diagnosis of untreated Obstructive Sleep Apnea Syndrome (OSAS).
- •Ongoing psychiatric disorders
研究组 & 干预措施
Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I.
干预措施: dorsal root ganglion stimulation cessation (Device)
结局指标
主要结局
Heart Rate
时间窗: 1 week
Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Physical Activity
时间窗: 1 week
Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked).
Heart Rate Variability
时间窗: 1 week
Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Body Temperature
时间窗: 1 week
Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Sleep Quality
时间窗: 1 week
Sleep quality is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked). For each night of sleep, the bed times and get-up times are entered (either manually, graphically or automatically) and the software automatically determines the sleep start and end times. The analysis then utilises the night-time movement data (e.g. immobile mins and mobile mins) to determine the quality of sleep and provides a list of key sleep parameters.
Respiratory Rate
时间窗: 1 week
Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Blood Pressure
时间窗: 1 week
Non-invasive Cuffless Blood Pressure: systolic, mean and diastolic (mmHg), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Oxygen Saturation
时间窗: 1 week
Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
次要结局
- Pain intensity(1 week)
- Sleep quality(1 week)
- Pain condition-related medication usage(1 week)
- Patient Global Impression of Improvement(1 week)