Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation
- Conditions
- Complex Regional Pain Syndromes
- Interventions
- Other: Multimodal rehabilitation
- Registration Number
- NCT05696587
- Lead Sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Clinical diagnosis of CRPS (or equivalent);
- MMSE >24 points;
- Has signed an informed consent to the study.
- MMSE ≤24 points;
- Inability to perform scheduled tasks (multimodal rehabilitation program).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRPS Multimodal rehabilitation Participants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks.
- Primary Outcome Measures
Name Time Method Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks. 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).
- Secondary Outcome Measures
Name Time Method 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 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).
Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks At baseline and in 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).
Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks At baseline and in 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).
Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks At baseline and in 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%).
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 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).
Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm Baseline 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%.
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 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).
Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks At baseline and in 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).
Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks At baseline and in 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).
Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. At baseline and in 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).
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 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).
Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. At baseline and in 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).
Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks. At baseline and in 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).
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 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).
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 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).
Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks. At baseline and in 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).
Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks. At baseline and in 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).
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 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).
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 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).
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 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).
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 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).
Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks. At baseline and in 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).
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 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).
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 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).
Mean score on the Mini-Mental State Examination (MMSE) at baseline. 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).
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 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).
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 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).
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 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).
Trial Locations
- Locations (1)
National Institute of Geriatrics, Rheumatology and Rehabilitation
🇵🇱Warsaw, Poland