NCT04767646已完成不适用
Evaluation of the Relationship Between the Duration of the Evolution of the Complex Regional Pain Syndrome Type 1 (CRPS 1) and Effectiveness of the Continuous Peripheral Nerve Block (CPNB) Associated With an Intensive Rehabilitation Program
Pôle Saint Hélier2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
研究概览
简要总结
The study evaluates the relationship between the duration of evolution of SDRC1 and the efficacy of continuous peripheral nerve block (c-PNB) associated with an intensive rehabilitation program to improve the therapeutic strategy of SDRC1.
The main hypothesis of this study is that if c-PNB is proposed earlier, the recovery, measured with a scale achievement of objectives, will be better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •informed consent signed
- •Diagnosis of CRPS type 1 according to BUDAPEST criteria to the upper or lower limb
- •Affiliated to a social security scheme (beneficiary or entitled person)
- •Patients justifying the installation of a Continuous Peripheral Nerve Block (CPNB) including pain rebellious to physical and medicinal treatments, the presence of fixed dystonia, or kinesiphobia or who are no longer progressing in the rehabilitation algorithm and requiring the need for a specialised technical platform.
排除标准
- •CRPS Type 2
- •Contra-indication to the analgesics used (bupivacaine, ropivacaine, levobupivacaine)
- •Severe psychiatric decompensation
- •Under legal protection measures
- •Pregnant women
研究组 & 干预措施
C-BNP with intensive rehabilitation program
Experimental
干预措施: Intensive rehabilitation program with CPNB (Procedure)
结局指标
主要结局
The composite score (the summation of the 3 Goal Attainment Scaling (GAS) scores)
时间窗: 1 year
The improvement of the composite score following BNPc combined with intensive rehabilitation.
次要结局
- Arthrometry assessment(1 year)
- hand joint assessment(1 year)
- activity assessment(1 year)
- Pain assessment(1 year)
- gripping force assessment(1 year)
- manual dexterity test(1 year)
- Assessment of functional capacity(1 year)
- Anxiety assessment(1 year)
- Assessment of activity limitation for a block of the upper limb(1 year)
- Assessment of activity limitation for a block of the lower limb(1 year)
- Assessment of the restriction of participation in social life(1 year)
- Evaluation of the effective dose(During the CPNB)
- Evaluation of the tolerance of CPNB(During the CPNB)
研究者
研究点 (2)
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