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Completed

NCT Number: NCT05696587

Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation

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.

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Key information

Conditions

Complex Regional Pain Syndromes Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, 02-637, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Mean change from baseline in Copy 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. 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).

  2. Mean change from baseline in pain score on the Numeric Rating Scale (NRS) at 4 weeks

    Time frame: 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).

  3. Mean change from baseline in Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) at 4 weeks in Participants with upper extremity CRPS

    Time frame: 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).

  4. Mean change from baseline in Lower Extremity Functional Scale (LEFS) at 4 weeks in Participants with lower extremity CRPS

    Time frame: 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).

  5. Number of Participants meeting the Budapest Criteria for CRPS at baseline as percent of Participants in the CRPS arm

    Time frame: 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%.

  6. Mean change from baseline in active range of motion (aROM) of affected joint at 4 weeks

    Time frame: 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%).

  7. Mean change from baseline in Central Sensitization Inventory (CSI) part A at 4 weeks

    Time frame: 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).

  8. Mean change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) part A score at 4 weeks

    Time frame: 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).

  9. Mean change from baseline in PainDetect Questionnaire (PDQ) score at 4 weeks

    Time frame: 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).

  10. Mean change from baseline in Diverting Attention score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  11. Mean change from baseline in Reinterpreting Pain Sensations score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  12. Mean change from baseline in Catastrophizing score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  13. Mean change from baseline in Ignoring Sensation score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  14. Mean change from baseline in Praying or Hoping score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  15. Mean change from baseline in Coping Self Statements score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  16. Mean change from baseline in Increased Behavioral Activity score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  17. Mean change from baseline in Control Over Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  18. Mean change from baseline in Ability to Decrease Pain score in The Pain Coping Strategy Questionnaire (CSQ) at 4 weeks.

    Time frame: 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).

  19. Mean score on the Mini-Mental State Examination (MMSE) at baseline.

    Time frame: 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).

  20. Mean change from baseline in Total Number Correct score in Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: 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).

  21. Mean change from baseline in Number of Errors score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: 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).

  22. Mean change from baseline in Digit Span (DS) score in Wechsler's Adult Intelligence Scale Revised (WAIS-R) at 4 weeks.

    Time frame: 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).

  23. Mean change from baseline in Beck Depression Inventory - II (BDI-II) score at 4 weeks.

    Time frame: 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).

  24. Mean change from baseline in Speed of Work score in the Attention and Perceptiveness Test (TUS) - at 4 weeks.

    Time frame: 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).

  25. Mean change from baseline in Number of Mistakes score in the Attention and Perceptiveness Test (TUS) at 4 weeks.

    Time frame: 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).

  26. Mean change from baseline in Number of Omissions in the Attention and Perceptiveness Test (TUS) at 4 weeks.

    Time frame: 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).

  27. Mean change from baseline in execution time in the Color-Trials Test part 1 (CTT-1) at 4 weeks.

    Time frame: 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).

  28. Mean change from baseline in shifting attention score on the Color-Trials Test part 2 (CTT-2) at 4 weeks.

    Time frame: 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).

Other outcomes

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

    Time frame: At baseline and in 4 weeks

    The CSQ is a self-reported instrument assessing 3 targets for pain-coping. The Emotion-oriented Coping score measures the tendency to have a strong emotional response to pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 72 (strategy significantly engaged). Change = (week 4 score - baseline score).

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

    Time frame: At baseline and in 4 weeks

    The CSQ is a self-reported instrument assessing 3 targets for pain-coping. The Avoidance-oriented Coping score measures the tendency to avoid the source of pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 72 (strategy significantly engaged). Change = (week 4 score - baseline score).

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

    Time frame: At baseline and in 4 weeks

    The CSQ is a self-reported instrument assessing 3 targets for pain-coping. The Task-oriented Coping score measures the tendency to address the source of pain as a pain-coping strategy. Possible scores range from 0 (strategy not engaged) to 108 (strategy significantly engaged). Change = (week 4 score - baseline score).

  4. Mean change from baseline in Distortions type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. The BVRT Distortions type of error means wrong answers in figure distortion. Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

  5. Mean change from baseline in Omissions type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. The BVRT Omissions type of error means wrong answers in figure omission. Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

  6. Mean change from baseline in Mispacements type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. The BVRT Mispacements type of error means wrong position of figure. Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

  7. Mean change from baseline in Perseverations type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. The BVRT Perseverations type of error means wrong figure repetition. Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

  8. Mean change from baseline in Rotations type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. The BVRT Rotations type of error means wrong answers in figure rotation. Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

  9. Mean change from baseline in Size error type of error in the score in the Benton Visual Retention Test (BVRT) at 4 weeks.

    Time frame: At baseline and in 4 weeks

    The BVRT is a task-based test assessing visual-spatial working memory and visual-spatial abilities. he BVRT Size error type of error means changing the figure size in wrong way.

    Possible scores range from 0 (best possible score) to infinite number (worst possible score). Change = (week 4 score - baseline score).

Sponsors and collaborators

Lead sponsor

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Network

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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