NCT05696587已完成不适用
Physical and Psychological Changes in Complex Regional Pain Syndrome (CRPS) Patients Undergoing Multimodal Rehabilitation
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
研究概览
简要总结
The goal of this clinical trial is to learn about cognitive changes during rehabilitation in CRPS patients. The main questions it aims to answer are:
- What are the cognitive changes in CRPS?
- Do cognitive functions change during multimodal rehabilitation in CRPS?
- What is the effect of multimodal rehabilitation on pain, functioning, mood, active range of motion, cognitive functions.
Participants will undergo a 4-week program of multimodal rehabilitation of physical therapy, education and Graded Motor Imagery. Assessment will be made at baseline and after 4 weeks.
Researchers will compare the interventional arm with healthy control to see if the observed psychological results are exclusive to CRPS group.
There is no expanded access scheduled for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Clinical diagnosis of CRPS (or equivalent);
- •MMSE >24 points;
- •Has signed an informed consent to the study.
排除标准
- •MMSE ≤24 points;
- •Inability to perform scheduled tasks (multimodal rehabilitation program).
结局指标
主要结局
Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
时间窗: At baseline and in 4 weeks
The RCFT is a task-based test assessing visual-spatial abilities. Reproduction score measures learning and planning on visual material. Possible scores range from 0 (significant deficit) to 36 (highest possible score). Change = (week 4 score - baseline score).
次要结局
- Mean change from baseline in Copy score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks(At baseline and in 4 weeks)
- Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks(At baseline and in 4 weeks)
- Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks(At baseline and in 4 weeks)
- Mean change from baseline in Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS(At baseline and in 4 weeks)
- Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm(Baseline)
- Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS(At baseline and in 4 weeks)
- Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks(At baseline and in 4 weeks)
- Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks(At baseline and in 4 weeks)
- Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Reinterpreting Pain Sensations score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Control Over Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Ability to Decrease Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Praying or Hoping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Coping Self Statements score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Increased Behavioral Activity score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Digit Span (DS) score in Wechsler's Adult Intelligence Scale Revised (WAIS-R) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Speed of Work score in the Attention and Perceptiveness Test (TUS) - at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in Number of Mistakes score in the Attention and Perceptiveness Test (TUS) at 4 weeks.(At baseline and in 4 weeks)
- Mean score on the Mini-Mental State Examination (MMSE) at baseline.(Baseline)
- Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in execution time in the Color-Trials Test part 1 (CTT-1) at 4 weeks.(At baseline and in 4 weeks)
- Mean change from baseline in shifting attention score on the Color-Trials Test part 2 (CTT-2) at 4 weeks.(At baseline and in 4 weeks)
研究者
研究点 (2)
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