Graded Motor Imagery Effects on Body Perception Disturbance in Complex Regional Pain Syndrome : a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- Body perception disorders (Bath Scale)
研究概览
简要总结
Complex Regional Pain Syndrome (CRPS) is a debilitating pain condition that usually develops following trauma. Patients with CRPS experience intense, continuing, disproportionate pain and multiple symptoms such as changes or asymmetry in colour, temperature or oedema, as well as stiffness, tremors or dystonia and body perception disturbances. Body perception disturbances are now recognised as part of the typical presentation of CRPS and have been shown to correlate, in particular, with pain intensity.
Managing CRPS is challenging and treatment options are limited. Among these, treatments aimed at cortical reorganisation, such as Graded Motor Imagery (GMI), have shown evidence of efficacy in terms of pain and function. However, with regard to body perception disorders, the evidence is limited and emerging.
Our aim is to evaluate the effects of Graded Motor Imagery on body perception disorders in patients with upper limb CRPS. Method: a randomised controlled trial comparing an intervention group - therapeutic exercises plus GMI for 6 weeks (implicit motor imagery, explicit motor imagery followed by mirror therapy) - with a control group - therapeutic exercises plus sham-GMI (non-motor mental imagery) for 6 weeks.
Outcome measures: body perception disorders (Bath Scale), pain intensity (Numerical Rating Scale), quality of life (PROMIS 29), catastrophising (PCS), fear of pain, CRPS Severity Score, patient-reported global impression of change, medication use and self-efficacy. Interventions are carried out in private practice by independent physiotherapists. Assessors are blinded for the primary outcome. A qualitative component will explore the experiences and perceptions of patients and therapists regarding body perception disturbances, GMI and participation in a research project.
This study aims are to improve treatment options for the management of SDRC and to improve the recognition and treatment of body perception disorders in SDRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Over 18 years
- •Upper limb unilateral CRPS (Budapest criteria)
- •No prior use of GMI
排除标准
- •Psychiatric disorders
- •Not confident with written/spoken French
- •Not confident with smartphone use
研究组 & 干预措施
Group "Graded Motor Imagery + Therapeutic exercises"
Graded Motor Imagery (left/right discrimination, explicit motor imagery, mirror therapy) and exercises (15 minutes, 3 times per day, 6 weeks)
干预措施: Graded Motor Imagery + Therapeutic exercises (Other)
Group "Sham-GMI (non-motor mental imagery) + Therapeutic exercises"
Sham-GMI (non-motor mental imagery) + Therapeutic exercises
干预措施: Sham-GMI (non-motor mental imagery) + Therapeutic exercises (Other)
结局指标
主要结局
Body perception disorders (Bath Scale)
时间窗: End of intervention (Week 6)
Assessment of body perception disturbances; 7 items
次要结局
- Body perception disorders (Bath Scale)(3 months after intervention (M3))
- Mean pain intensity (Numeric rating scale)(End of intervention (Week 6), 3 months after intervention (M3))
- QuickDash(End of intervention (Week 6), 3 months after intervention (M3))
- PROMIS 29(End of intervention (Week 6), 3 months after intervention (M3))
- Pain Catastrophizing Scale (PCS)(End of intervention (Week 6), 3 months after intervention (M3))
- Tampa Scale of Kinesiophobia (short form)(End of intervention (Week 6), 3 months after intervention (M3))
- Pain Self Efficacy Questionnaire (PSEQ)(End of intervention (Week 6), 3 months after intervention (M3))
- Patient Global Impression of Change (PGIC)(End of intervention (Week 6), 3 months after intervention (M3))
- Medication Quantification Scale (MQS)(End of intervention (Week 6), 3 months after intervention (M3))