[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100266863":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":50,"overallOfficials":55,"centralContacts":60,"locations":67,"responsibleParty":87,"collaborators":89,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":34,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":34,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University Hospital of North Norway","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Throughout the baseline and intervention phases, up to 12 months",[14,17,21,24,28,31],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","Repeatedly throughout the baseline and intervention phases, up to 12 months",{"measure":22,"description":23,"timeFrame":20},"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.",{"measure":25,"description":26,"timeFrame":27},"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.","Baseline and 12 months",{"measure":29,"description":30,"timeFrame":27},"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.",{"measure":32,"description":33,"timeFrame":27},"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.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"NA","SINGLE_GROUP","Prospective multiple-baseline single-case experimental design (SCED). Participants are randomized to a baseline duration of 2, 3, or 4 weeks, resulting in staggered introduction of the intervention across participants. All participants receive the same overall rehabilitation approach, individually tailored according to their needs and response. Repeated measurements are collected throughout the baseline and intervention phases, allowing each participant to serve as their own control.","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","The study comprises two complementary work packages (WPs).\n\nWork 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.\n\nRepeated 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.\n\nAdditional 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).\n\nQuantitative 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.\n\nWork 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.\n\nTogether, 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.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Individualized CRPS Rehabilitation","EXPERIMENTAL","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.",[49],"Behavioral: Individualized CRPS Rehabilitation",[51],{"type":52,"name":45,"description":53,"armGroupLabels":54,"otherNames":34},"BEHAVIORAL","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.\n\nGMI includes left\u002Fright 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.\n\nTactile 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.\n\nThe 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",[45],[56],{"name":57,"affiliation":58,"role":59},"Lena Danielsson, PhD","University Hospital og North Norway","STUDY_DIRECTOR",[61,64],{"name":57,"role":62,"phone":34,"phoneExt":34,"email":63},"CONTACT","lena.danielsson@unn.no",{"name":65,"role":62,"phone":34,"phoneExt":34,"email":66},"Kvarstein Gunnvald, PhD","Gunnvald.Kvarstein@uit.no",[68],{"facility":5,"status":69,"city":70,"state":34,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Tromsø","9038","Norway","NO",{"type":75,"coordinates":76},"Point",[77,78],18.95508,69.6489,{"lat":78,"lon":77},[81,84],{"name":82,"role":62,"phone":83,"phoneExt":34,"email":63},"Lena Danielsson","+4777669307",{"name":85,"role":62,"phone":34,"phoneExt":34,"email":86},"Gunnvald Kvarstein","gunnvald.kvarstein@unn.no",{"type":88,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[90,92,94,96],{"name":91,"class":6},"UiT The Arctic University of Norway",{"name":93,"class":6},"Örebro University, Sweden",{"name":95,"class":6},"The Royal Norwegian Ministry of Health",{"name":97,"class":6},"University of Liverpool","100266863","a-comparison-of-two-treatments-for-crps-and-changes-in-resting-state-connectivity-of-cerebral-networks-100266863",false,"NCT02753335","Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome","Clinical and Cerebral Changes Following Multifaceted Rehabilitation of Complex Regional Pain Syndrome: A Single-Case Experimental Design.","Inclusion Criteria:\n\n* Age 18 years or older. For participants included in WP2 (MRI), the maximum age is 70 years.\n* Diagnosis of Complex Regional Pain Syndrome (CRPS) according to the Budapest criteria.\n* CRPS affecting a single upper or lower limb.\n* Triggering trauma or onset of pain more than 3 months before inclusion.\n\nExclusion Criteria:\n\n* Drug abuse.\n* Malignant or progressive disease, systemic disease, or neurodegenerative disease.\n* Other severe pain conditions.\n* Severe anxiety or depression.\n* Disabling fatigue or myalgic encephalomyelitis (ME).\n* Use of opioid medication exceeding 100 mg oral morphine equivalents (OMEQ).\n\nAdditional Exclusion Criteria for WP2 (MRI):\n\n* History of seizures.\n* Neurological or neurosurgical disorders.\n* Significant cardiac or systemic illness.\n* Implanted metallic or electronic devices incompatible with MRI.\n* Diagnosis of a developmental disorder.\n* Current use of antipsychotic medications, benzodiazepines, or other pharmacological agents that may influence MRI measurements.\n* Pregnancy or lactation.\n* Phobia of MRI examination.","ALL","18 Years","70 Years",{"count":109,"type":110},12,"ESTIMATED","INTERVENTIONAL",[36],"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.",[115],"Complex Regional Pain Syndrome (CRPS)",[117],"Complex Regional Pain Syndrome, CRPS, SCED, Graded Motor Imagery, Tactile Desensitization, Psychologically Informed Care, MRI","2026-10-05",{"date":120,"type":121},"2026-10-08","ACTUAL",{"date":123,"type":121},"2016-09",{"date":125,"type":110},"2032-11-15",{"name":5,"class":6},1]