Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation

NCT05696587 | Completed

• 1 other identifier: STATUT 2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes

Keywords

CRPS; cognitive functions; physical therapy; pain; Graded Motor Imagery; mirror therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• 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 Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS

  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

  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

Other Outcomes (9)

• Mean change from baseline in Emotion-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

  At baseline and in 4 weeks

• Mean change from baseline in Avoidance-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

  At baseline and in 4 weeks

• Mean change from baseline in Task-oriented Coping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

  At baseline and in 4 weeks

Study Arms (2)

CRPS

EXPERIMENTAL

Participants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks.

Other: Multimodal rehabilitation

Healthy Control

NO INTERVENTION

Participants matched according to sex, age and education to experimental arm, undergoing psychological assessment at baseline and at 4 weeks.

Interventions

Multimodal rehabilitation OTHER

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.

CRPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of CRPS (or equivalent);
• MMSE \>24 points;
• Has signed an informed consent to the study.

You may not qualify if:

• MMSE ≤24 points;
• Inability to perform scheduled tasks (multimodal rehabilitation program).

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead

Study Sites (1)

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, 02-637, Poland

Location

Related Publications (28)

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MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beata Tarnacka, ASSC PROF

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  STUDY DIRECTOR

• Adam Zalewski, MD

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: October 10, 2021
• Primary Completion: January 20, 2023
• Study Completion: February 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

PL (1)