Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS). Which Are the Predictors for Return to Work and Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- patient return to work (RTW)
研究概览
简要总结
Complex regional pain syndrome (CRPS) is a post-traumatic chronic pain condition characterized by pain and other symptoms typically affecting a distal limb. Relatively little is known about the prognosis of the course of CRPS .Currently there is no specific test to diagnose CRPS.
The primary objective of the study is to investigate prospectively the evolution of CRPS and the impact of the psychosocial factors on health status, recovery, quality of life, and working status of CRPS patients.
The secondary objective of the study is to measure blood parameters in CRPS patients to investigate their evolution during the course of CRPS, and maybe to identify distinctive biomarkers associate with CRPS and that could be potential candidate for diagnosis.
详细描述
The first aim will be to monitor the evolution of the following parameters in CRPS patients:
- Quality of life
- Symptoms and signs of CRPS
- Severity of CRPS
- Working status
- Pain
- Disability
- Anxiety and depression
- Kinesiophobia
- Catastrophism
- Activity patterns with chronic pain during the two years follow-up. Every parameter will be evaluated with a questionnaire that allows assigning scores to each patient.
Additionally sociodemographic data will be collected to characterize the patients (age, gender, marital status, educational level). The health status, treatment and medication of the patients will also be recorded with a medical follow-up during the two years.
The aim is to know if the following parameters and their evolution:
- Sociodemographic factors,
- Pain,
- Disability,
- Anxiety and depression,
- Kinesiophobia,
- Catastrophism,
- Activity patterns with chronic pain
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
patient return to work (RTW)
时间窗: 2 years after inclusion
Percentage of patients return to work at T4
Recovery of CRPS
时间窗: 2 years after inclusion
Disability of the patients evaluated with DASH questionnaire for upper limb and FAMM questionnaire for lower limb at T4. For DASH the score range from 0 to 100, with 100 represent the worst disability. For FAMM the score range from 0 to 100, 100 represent the best functionality.
次要结局
- miRNAs and cytokines profile of patients and control(at T0 (after inclusion))
- miRNAs and cytokines profile of patients(1 year after inclusion)