An interventional study of Individualized CRPS Rehabilitation in Complex Regional Pain Syndrome (CRPS), sponsored by University Hospital of North Norway. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Treatment
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.
The study comprises two complementary work packages (WPs).
Work Package 1 (WP1) uses a prospective randomized multiple-baseline single-case experimental design (SCED) to evaluate the rehabilitation process and clinical effects in individual participants with Complex Regional Pain Syndrome (CRPS). Participants are randomized to a baseline duration of 2, 3, or 4 weeks before the intervention is introduced. The rehabilitation combines Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. Treatment is individually tailored and may be adjusted according to the participant's needs and response.
Repeated measurements of "How much has CRPS interfered with your daily activities during the past 24 hours?" and "How severe has your average pain been during the past 24 hours?" are collected throughout the study to evaluate changes within each participant and their temporal relationship to the introduction and adjustment of treatment. Validated measures of upper- or lower-limb function (QuickDASH or LEFS) are also collected repeatedly.
Additional standardized questionnaires are administered at baseline and 12 months to characterize the participants and to assess factors that may be associated with clinical and neuroimaging outcomes. These include measures of insomnia (ISI), psychological distress (HSCL-25), pain catastrophizing (PCS), self-efficacy (GSE), fatigue (CFQ), body perception disturbance (Bath CRPS Body Perception Disturbance Scale), neglect-like symptoms, and health-related quality of life (EQ-5D-5L).
Quantitative sensory testing (QST) is conducted to characterize sensory function, including thermal detection and pain thresholds. Neuropsychological testing is conducted to characterize general cognitive abilities, sustained attention, impulsivity, visuomotor reaction time, and executive functioning.
Work Package 2 (WP2) investigates brain structure and its relationship to CRPS using magnetic resonance imaging (MRI). MRI is performed at baseline and after 12 months. Structural brain characteristics, including gray matter morphology and white matter microstructure, in participants with CRPS will be compared with those of healthy controls. Longitudinal MRI will also be used to investigate structural brain changes over time in participants with CRPS and whether these changes are associated with limb function and pain intensity.
Together, the two work packages aim to improve understanding of individual clinical responses to rehabilitation and of structural brain characteristics and their potential changes over time in CRPS.
205 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
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Exclusion Criteria:
Additional Exclusion Criteria for WP2 (MRI):
Participants receive an individually tailored rehabilitation intervention combining Graded Motor Imagery (GMI) and tactile desensitization (TD) within a Psychologically Informed Care (PIC) framework. The intervention is adapted according to individual needs, treatment response, and progression throughout the rehabilitation period.
Behavioral: Individualized CRPS Rehabilitation
The 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
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 months
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 months
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 months
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 months
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 months
Gray matter brain morphology
Gray matter brain morphology assessed from structural MRI using FreeSurfer. MRI-derived measures in participants with CRPS will be compared with those of healthy controls at baseline. Longitudinal changes in participants with CRPS will also be assessed from baseline to 12 months.
Time frame: Baseline and 12 months
White matter microstructure
White matter microstructure assessed using diffusion tensor imaging (DTI), including fractional anisotropy (FA), mean diffusivity (MD), and radial diffusivity (RD). White matter measures in participants with CRPS will be compared with those of healthy controls at baseline. Longitudinal changes in white matter microstructure will also be assessed in participants with CRPS from baseline to 12 months.
Time frame: Baseline and 12 months
Plan to share: No
Started Sep 2016 (actual). Primary completion is estimated for May 2030, 164 months after the start.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 164 months is above that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Dec 2023 → May 2030 and completion Dec 2024 → Nov 2032.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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