Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
研究概览
简要总结
Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Planning of the study :
- Total duration: 34 months
- Recruitment period: 24 months.
- Follow-up time per patients : 7-10 months
Expected number of cases : 12
Treatment, procedure, combination of procedures under consideration :
During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.
There will be a random draw on the order of the stimulation program:
- the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
- burst stimulation (or "burst")
- high frequency" stimulation (1000 Hz) "High frequency: HF".
- combined tonic + burst stimulation
- combined tonic + high frequency stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will only know the stimulation modes
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
时间窗: 6 Months
Comparison of the average of the visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)score collected during the 7 days of stimulation by the Tonic+Burst mode to the average of the visual analogic scale score collected during the 7 days in tonic stimulation
Evaluating the overall satisfaction with the stimulation mode
时间窗: 6 Months
Daily collection of the patient's evaluation of his satisfaction on the remote control - the patient's logbook by a number of stars: 1\* (one star) not satisfied and 5\* (five stars) very satisfied
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
时间窗: 6 Months
Comparison of the average visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome) score of the 7 days of the Tonic+Burst mode compared to the average visual analogic scale scores collected in Tonic stimulation alone.
次要结局
- Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode(6 Months)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency(6 Months)
- Evaluating average daily analgesic consumption at 1 month(1 month)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency(6 Months)
- Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only(6 Months)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort(6 Months)
- Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the pain criteria(6 Months)
- Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.(6 Months)
- Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the satisfaction(6 Months)
- Evaluating average daily analgesic consumption at inclusion.(0 month)
- Evaluating average daily analgesic consumption at 3 months(3 month)
- Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only(6 Months)
- Comparison of the number of recharges of the device according to the stimulation modes(6 Months)
- Evaluating average daily analgesic consumption at 6 months(6 month)
- Evaluating the change in the quality of life of patients at 1 month(1 month)
- Evaluating the change in the quality of life of patients at 3 months(3 months)
- Evaluating the change in the quality of life of patients at 6 months(6 months)