Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy in the Complex Regional Pain Syndrome of the Upper Limb : a Multicentric Randomized Open Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Compare the Visual Analogue Scale (EVA) of pain
研究概览
简要总结
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.
Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.
详细描述
The Complex Regional Painful Syndromes (CRPS) called in the past aglodystrophia, are characterized by the apparition of pain abnormally spread and intensive compared to the initial causal factor. They are usually associated to negligence of the painful limb, and avoidance movements that require care in rehabilitation that it is carried out in the physiotherapist center or functional rehabilitation unit at hospital.
Recently, mirror therapy has been proposed to correct dysfunctions : patients have to realize a movement with their two hands, observing the reflect of their healthy hand in a mirror, while their painful hand is hidden behind the mirror. After a learning phase, patients have to continue this kind of therapy independently.
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.
Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.
The primary outcome of this project is to compare analgesic effect at 8 and 16 weeks of a therapy mirror re-education program associated to a usual care (M+R), and of a usual care program (R).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Affiliation to Social Security
- •CRPS (complex regional pain syndrome) type I or II defined by the criteria of Bruehl (Table 1)
- •CRPS of the upper limb including the wrist and / or hand
- •CRPS post-surgical or post-traumatic
- •Average pain in the last 24 hours of intensity > = 30/100 on EVA (0 no pain, 100: worst pain imaginable )
- •Evolution for over 3 months and less than 2 years
- •Patients taking a stable background therapy for 15 days and not having received the following treatments in the previous months : bisphosphonate cure, infiltration, Qutenza, ketamine infusions
- •Patients accepting a rehabilitation (physiotherapists or hospital units for patients included on Saint-Etienne and hospital units for patients included in Lyon and Saint- Vallier)
排除标准
- •CRPS post stroke or drug
- •Adhesive capsulitis isolated
- •Cognitive or language difficulties preventing understanding instructions and / or a correct clinical evaluation
- •Patient who already received a rehabilitation program with the use of mirror therapy or other virtual reality technology
- •CRPS in connection with an accident caused by a third party for which a legal procedure is underway
- •Major Depressive Episode
- •Dissociative Disorders
- •Visually impaired patients
结局指标
主要结局
Compare the Visual Analogue Scale (EVA) of pain
时间窗: Week 8
Compare after 8 weeks the score of EVA of pain in the last 24 hours for patients who performed during 8 weeks : * a program of mirror therapy associated with the usual care (M+R) or * the usual care without mirror therapy
次要结局
未报告次要终点