Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04913051
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate impact of day hospital care on quality of life', 'timeFrame': '3 months after day hospital', 'description': 'Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36). A score ranging from 0 to 100 is obtained. A low score reflects a perception of poor health, loss of function, presence of pain.'}, {'measure': 'Evaluate impact of day hospital care on quality of life', 'timeFrame': '6 months after day hospital', 'description': 'Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36). A score ranging from 0 to 100 is obtained. A low score reflects a perception of poor health, loss of function, presence of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Regional Pain Syndrome', 'day hospital', 'Chronic Pain Unit'], 'conditions': ['Chronic Regional Pain Syndrome']}, 'descriptionModule': {'briefSummary': "Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders.\n\nIts pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization.\n\nThe diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination.\n\nThe treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres.\n\nThe investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic Regional Pain Syndrome referred to the Chronic Pain Facility for the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient volunteers over 18 years of age\n* Diagnosis of CRPS according to the Budapest criteria\n* Referred to pain assessment and treatment center\n\nExclusion Criteria:\n\n* Patients unable to express their wishes or understand the protocol\n* Diagnosis of CRPS not meeting Budapest criteria\n* Patients previously seen at pain assessment and treatment center for the care of CRPS'}, 'identificationModule': {'nctId': 'NCT04913051', 'briefTitle': 'Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time', 'orgStudyIdInfo': {'id': 'CHM-2020/S44/15'}}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '02 44 71 07 81'}], 'facility': 'Centre Hospitalier Du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '02 44 71 07 81'}, {'name': 'Nathalie DEROUET, MD', 'role': 'CONTACT', 'email': 'nderouet@ch-lemans.fr', 'phone': '02 43 43 43 43'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}