Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 1:21 PM
Study NCT ID:
NCT04597866
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis', 'timeFrame': '1 day', 'description': 'Whether the subject still fulfill diagnostic criteria for CRPS'}, {'measure': 'Subjective experience', 'timeFrame': '1 day', 'description': 'A qualitative interview targeting the subjects own experience of the treatment and its effect'}], 'secondaryOutcomes': [{'measure': 'Level of pain', 'timeFrame': '1 day', 'description': 'Subjective level of pain on a Likert-scale 0-10 (NRS)'}, {'measure': 'Subjective experience of quality of life', 'timeFrame': '1 day', 'description': 'Quality of life, measured with the RAND-36 (0-100, higher scores mean a better outcome)'}, {'measure': 'Global impression of change', 'timeFrame': '1 day', 'description': 'Global impression of change measured with a single question (0-6, higher scores mean a better outcome)'}, {'measure': 'Acceptance of pain', 'timeFrame': '1 day (0-156, higher scores mean a better outcome)', 'description': 'Measured with the Chronic Pain Acceptance Questionnaire, CPAQ (0-156, higher scores mean a better outcome)'}, {'measure': 'Fear of pain', 'timeFrame': '1 day (0-52, lower scores mean a better outcome)', 'description': 'Measured with the Tampa Scale of Kinesiophobia, TSK (0-52, lower scores mean a better outcome)'}, {'measure': 'Pain catastrophizing', 'timeFrame': '1 day (0-52, lower scores mean a better outcome)', 'description': 'Measured with Pain Catastrophizing Scale, PCS (0-52, lower scores mean a better outcome)'}, {'measure': 'Avoidance of activities', 'timeFrame': '1 day (0-100, lower scores mean a better outcome)', 'description': 'Measured with the Photograph Series of Daily Activities, PHODA (0-100, lower scores mean a better outcome)'}, {'measure': 'Neglect of the affected limb', 'timeFrame': '1 day (0-36, lower scores mean a better outcome)', 'description': 'Measured with a five item questionnaire (0-36, lower scores mean a better outcome)'}, {'measure': 'Subjective experience of quality of life 2', 'timeFrame': '1 day', 'description': 'EuroQol 5D, EQ-5D (0-15, higher scores means a better outcome)'}, {'measure': 'Subjective experience of quality of life 3', 'timeFrame': '1 day', 'description': 'Life Satisfaction Questionnaire, LiSat 11 (11-66, higher scores means a better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Regional Pain Syndromes', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified.\n\nA combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS.\n\nThe present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with CRPS 1 or 2, diagnosed according to the Budapest criteria that has received in-patient treatment at Uppsala University Hospital, comprised of graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has participated in multimodal treatment for CRPS at Uppsala University Hospital\n\nExclusion Criteria:\n\n* Other serious physical or mental condition'}, 'identificationModule': {'nctId': 'NCT04597866', 'acronym': 'TORNADO', 'briefTitle': 'Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up', 'orgStudyIdInfo': {'id': '2020-03383'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRPS', 'interventionNames': ['Behavioral: Multimodal rehabilitation']}], 'interventions': [{'name': 'Multimodal rehabilitation', 'type': 'BEHAVIORAL', 'description': 'A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.', 'armGroupLabels': ['CRPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Kristoffer Bothelius, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}