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

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland1 site in 1 country42 target enrollmentOctober 10, 2021

ConditionsComplex Regional Pain Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Complex Regional Pain Syndromes
Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Enrollment: 42
Locations: 1
Primary Endpoint: Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2021

End Date

February 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Mean change from baseline in Reproduction score on the Rey's Complex Figure Test (RCFT) score at 4 weeks.

Time Frame: 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 Outcomes

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)