Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Physical and Psychological Changes in Complex Regional Pain Syndrome (CRPS) Patients Undergoing Multimodal Rehabilitation

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Other: Multimodal rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of CRPS (or equivalent); MMSE >24 points; Has signed an informed consent to the study. Exclusion Criteria: MMSE ≤24 points; Inability to perform scheduled tasks (multimodal rehabilitation program).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment arm will undergo a 4-week multimodal rehabilitation program with outcome measures recorded at baseline and at 4 weeks. Healthy control will be assessed for psychological outcome measures at baseline and at 4 weeks, with no intervention applied.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRPS<br>Participants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks. | Other: Multimodal rehabilitation<br>* The multimodal rehabilitation program included comprehensive therapy 5 times a week during the 4 weeks between assessments. The therapy consists of: Individual physical therapy focused on improving range of motion and alleviating pain in the affected limb; Mechanical desensitization; Transcutaneous electric nerve stimulation (TENS) electrotherapy; Aquatherapy (arm or leg whirlpool bath of the affected extremity); Graded Motor Imagery, including the Recognise™ app and mirror therapy; Psychoeducation on relaxation and coping with chronic pain.<br>|
| No Intervention: Healthy Control<br>Participants matched according to sex, age and education to experimental arm, undergoing psychological assessment at baseline and at 4 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 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). | At baseline and in 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Copy score on the Rey's Complex Figure Test (RCFT) score at 4 weeks. | The RCFT is a task-based test assessing visual-spatial abilities. Copy score measures planning on visual material. Possible scores range from 0 (significant deficit) to 36 (highest possible score). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks | The NRS is a self-reported instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (week 4 score - baseline score). | 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 | The DASH is a self-reported instrument assessing ability to perform certain upper extremity activities. Possible scores range from 0 (no disability) to 100 (complete disability). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS | The LEFS is a self-reported instrument assessing ability to perform certain lower extremity activities. Possible scores range from 0 (complete disability) to 80 (no disability). Change = (week 4 score - baseline score). | 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 | The Budapest Criteria are a set of clinical criteria used to diagnose CRPS. Possible outcomes include: CRPS-I, CRPS-II, CRPS-RSF, not meeting Budapest Criteria. Number = ((number of CRPS-I + number of CRPS-II + number of CRPS-RSF) / total Participants in CRPS arm) * 100%. | Baseline | 
| Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks | The aROM is a clinical measure calculated as an angle between extreme positions of a joint. Possible scores range from 0° (no motion) to 360° (full rotation). Change = ((week 4 score / baseline score) * 100%). | At baseline and in 4 weeks | 
| Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks | The CSI is a self-reported instrument assessing overlapping health-related symptom dimensions of central sensitization. Possible scores range from 0 (subclinical) to 100 (extreme). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks | The SF-MPQ is a self-reported instrument assessing different types of pain. Possible scores range from 0 (no pain) to 45 (severe pain). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks | The PDQ is a self-reported instrument assessing neuropathic pain. Possible scores range from -1 (neuropathic component <15%) to 38 (neuropathic component >90%). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Diverting Attention score measures the use of attention diversion as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Reinterpreting Pain Sensations score measures the use of pain sensation reinterpretation as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Catastrophizing score measures the use of catastrophising as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Ignoring Sensation score measures the use of ignoring pain sensation as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Praying or Hoping score measures the use of prayer and wishful thinking as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Coping Self Statements score measures positive self-affirmations as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Increased Behavioral Activity score measures the use of behavioral activity increase as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 36 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Control Over Pain score measures the notion of control over pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 6 (strategy significantly engaged). Change = (week 4 score - baseline score). | 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. | The CSQ is a self-reported instrument assessing different pain coping strategies. The Ability to Decrease Pain score measures the notion of being able to decrease pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 6 (strategy significantly engaged). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean score on the Mini-Mental State Examination (MMSE) at baseline. | The MMSE is a clinician-reported screening test assessing general cognitive functioning. Possible scores range from 0 (severe cognitive deficit) to 30 (no cognitive deficit). | Baseline | 
| Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks. | The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. Total Number Correct score counts correct answers. Possible scores range from 0 (significant deficit) to 10 (highest possible score). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks. | The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. Number of Errors score counts wrong answers. Possible scores range from 0 (best possible score) to infinite number of errors (worst possible score). Change = (week 4 score - baseline score). | 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. | WAIS-R is a task-based test assessing intelligence. The DS score measures attention and working memory. Possible scores range from 0 (significant deficit) to 28 (highest possible score). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks. | The BDI-II is a self-reported questionnaire assessing depression severity. Possible scores range from 0 (no depression) to 66 (severe depression). Change = (week 4 score - baseline score). | 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. | The TUS is a task-based test assessing attention. Speed of Work measures number of tasks completed in a fixed amount of time. Possible scores range from 0 (lowest possible speed) to 972 (highest possible speed). Change = (week 4 score - baseline score). | 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. | The TUS is a task-based test assessing attention. Number of Mistakes score measures resistance to distraction. Possible scores range from 0 (perfect score) to 972 (worst possible score). Change = (week 4 score - baseline score). | At baseline and in 4 weeks | 
| Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks. | The TUS is a task-based test assessing attention. Number of Omissions score measures resistance to distraction. Possible scores range from 0 (perfect score) to 349 (worst possible score). Change = (week 4 score - baseline score). | 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. | The CTT-1 is a task-based test assessing psychomotor speed in time (seconds). Possible scores range from 0s (impossibly fast) to infinite time (unable to complete). Change = (week 4 time in seconds - baseline time in seconds). | 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. | The CTT-2 is a task-based test assessing shifting attention in time (seconds). Possible scores range from 0s (impossibly fast) to infinite time (unable to complete task). Change = (week 4 time in seconds - baseline time in seconds). | At baseline and in 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRPS, cognitive functions, physical therapy, pain, Graded Motor Imagery, mirror therapy, rehabilitation