Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital of North Norway
About this trial
This study investigates the clinical effects of an individually tailored rehabilitation program for patients with Complex Regional Pain Syndrome (CRPS). A randomized multiple-baseline single-case experimental design (SCED) will be used to evaluate individual changes in CRPS interference with daily activities, pain, and limb function during rehabilitation. Treatment components will be adjusted according to each participant's needs and response to treatment. The study will also use magnetic resonance imaging (MRI) to investigate brain structure in patients with CRPS compared with healthy controls and to examine whether brain structure changes over time in patients with CRPS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older. For participants included in WP2 (MRI), the maximum age is 70 years.
Diagnosis of Complex Regional Pain Syndrome (CRPS) according to the Budapest criteria.
CRPS affecting a single upper or lower limb.
Triggering trauma or onset of pain more than 3 months before inclusion.
Disqualifiers
Drug abuse.
Malignant or progressive disease, systemic disease, or neurodegenerative disease.
Other severe pain conditions.
Severe anxiety or depression.
Trial design
Design model
Single group
Treatments tested in this trial
Individualized CRPS Rehabilitation
BehavioralThe rehabilitation intervention combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and adjusted according to the participant's needs, treatment response, and progression throughout the rehabilitation period. GMI includes left/right discrimination training, motor imagery, and mirror therapy. The components are introduced and progressed flexibly according to the participant's individual abilities and response to treatment. Tactile desensitization aims to reduce sensory hypersensitivity and improve tolerance of sensory input through repeated and gradually progressed tactile stimulation of the affected area using different materials and stimuli. The PIC framework integrates physical rehabilitation with psychological principles and strategies addressing cognitive, emotional, and behavioral factors relevant to pain, movement, and daily functioning. The specific treatment components
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Individualized CRPS RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CRPS interference with daily activities
Participant-reported CRPS interference with daily activities, assessed using a single-item 0-10 Numeric Rating Scale (NRS): "How much has CRPS interfered with your daily activities during the past 24 hours?" Higher scores indicate greater interference (0 = not at all; 10 = to a very great extent). Repeated measurements are collected throughout the baseline and intervention phases as the primary target variable in the multiple-baseline single-case experimental design.
Time frame
Throughout the baseline and intervention phases, up to 12 monthsSecondary outcomes
1
Average pain intensity
Participant-reported average pain intensity during the past 24 hours, assessed using a single-item 0-10 Numeric Rating Scale (NRS): "How severe has your average pain been during the past 24 hours?" The NRS ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity. Repeated measurements are collected throughout the baseline and intervention phases.
Time frame
Throughout the baseline and intervention phases, up to 12 months2
Lower extremity function (LEFS)
Lower extremity function assessed using the Lower Extremity Functional Scale (LEFS) in participants with CRPS affecting the lower extremity. The LEFS consists of 20 items assessing difficulty in performing everyday activities. Each item is scored from 0 to 4, giving a total score ranging from 0 to 80, with higher scores indicating better lower extremity function. The LEFS is assessed repeatedly throughout the study.
Time frame
Repeatedly throughout the baseline and intervention phases, up to 12 months3
Upper extremity function (QuickDASH)
Upper extremity function assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with CRPS affecting the upper extremity. The QuickDASH consists of 11 items assessing difficulty in performing activities and the impact of upper extremity symptoms. The total score ranges from 0 to 100, with higher scores indicating greater disability. The QuickDASH is assessed repeatedly throughout the study.
Time frame
Repeatedly throughout the baseline and intervention phases, up to 12 months4
CRPS severity (CRPS Severity Score)
CRPS severity assessed using the CRPS Severity Score (CSS), which comprises 16 clinical signs and symptoms of CRPS. Each item is scored as present (1) or absent (0), resulting in a total score ranging from 0 to 16, with higher scores indicating greater CRPS severity.
Time frame
Baseline and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of North Norway
Lead sponsor
UiT The Arctic University of Norway
Collaborator
Örebro University, Sweden
Collaborator
The Royal Norwegian Ministry of Health
Collaborator
University of Liverpool
Collaborator
Source ClinicalTrials.gov