Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain assessment at 3 months after implant
研究概览
简要总结
In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.
详细描述
There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.
There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.
The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.
In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years of age
- •Patient with CRPS of at least one upper limb
- •Patient affiliated to a Social Security plan
- •Patient who has signed and dated the no-objection form
- •Patient with the cognitive ability to understand the treatment and complete the questionnaires
- •Patient who can be followed for a minimum of 1 year
排除标准
- •Patient with an uncontrolled infection
- •Pregnant or breastfeeding patient
- •Patient who has already undergone treatment by spinal cord stimulation
- •Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...)
- •Patient who cannot be followed regularly for psychological, social, family or geographical reasons
- •Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
结局指标
主要结局
Pain assessment at 3 months after implant
时间窗: 3 months
The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).
次要结局
- qualitatively evaluate the effectiveness of the procedure(3 months)
- procedure assesment(1 month, 3 months, 6 months and 12 months)
- Medication use(1 month, 3 months, 6 months and 12 months)
- Assessing attention and working memory(3 months and 12 months)