Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation
NCT ID: NCT05696587
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-10-10
2023-02-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CRPS
Participants meeting inclusion and exclusion criteria undergoing 4-week multimodal rehabilitation, undergoing assessment at baseline and at 4 weeks.
Multimodal rehabilitation
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.
Healthy Control
Participants matched according to sex, age and education to experimental arm, undergoing psychological assessment at baseline and at 4 weeks.
No interventions assigned to this group
Interventions
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Multimodal rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* MMSE \>24 points;
* Has signed an informed consent to the study.
Exclusion Criteria
* Inability to perform scheduled tasks (multimodal rehabilitation program).
18 Years
ALL
Yes
Sponsors
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National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
NETWORK
Responsible Party
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Principal Investigators
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Beata Tarnacka, ASSC PROF
Role: STUDY_DIRECTOR
National Institute of Geriatrics, Rheumatology and Rehabilitation
Adam Zalewski, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Geriatrics, Rheumatology and Rehabilitation
Locations
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National Institute of Geriatrics, Rheumatology and Rehabilitation
Warsaw, , Poland
Countries
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References
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Other Identifiers
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STATUT 2020
Identifier Type: -
Identifier Source: org_study_id
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