Clinical trial NCT05696587: Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation
Official title: Physical and Psychological Changes in Complex Regional Pain Syndrome (CRPS) Patients Undergoing Multimodal Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: CRPS
cognitive functions
physical therapy
pain
Graded Motor Imagery
mirror therapy
rehabilitation
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
First posted: 2023-01-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
timeFrame: At baseline and in 4 weeks
Secondary outcomes:
measure: Mean change from baseline in Copy score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS
timeFrame: At baseline and in 4 weeks
measure: Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm
timeFrame: Baseline
measure: Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Reinterpreting Pain Sensations score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Praying or Hoping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Coping Self Statements score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Increased Behavioral Activity score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Control Over Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Ability to Decrease Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean score on the Mini-Mental State Examination (MMSE) at baseline.
timeFrame: Baseline
measure: Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Digit Span (DS) score in Wechsler's Adult Intelligence Scale Revised (WAIS-R) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Speed of Work score in the Attention and Perceptiveness Test (TUS) - at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Number of Mistakes score in the Attention and Perceptiveness Test (TUS) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in execution time in the Color-Trials Test part 1 (CTT-1) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in shifting attention score on the Color-Trials Test part 2 (CTT-2) at 4 weeks.
timeFrame: At baseline and in 4 weeks
Other outcomes:
measure: Mean change from baseline in Emotion-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Avoidance-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Task-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Distortions type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Omissions type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Mispacements type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Perseverations type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Rotations type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
measure: Mean change from baseline in Size error type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.
timeFrame: At baseline and in 4 weeks
Locations:
city: Warsaw
country: Poland
facility: National Institute of Geriatrics, Rheumatology and Rehabilitation
Study officials:
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Beata Tarnacka, ASSC PROF
role: STUDY_DIRECTOR
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Adam Zalewski, MD
role: PRINCIPAL_INVESTIGATOR
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