[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100324827":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1: Patients with small fiber neuropathy",null,"patients with Sjogren syndrome have a definite small fiber neuropathy",[13],"Other: Collection sheet",{"label":15,"type":10,"description":16,"interventionNames":10},"2: Patients without peripheral neuropathy","patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber)",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Collection sheet","Using EQ5D questionnaire and a collection of care resources consumed by the patients during a period of 6 months associated by using validated scales (SF36, DN4, PROFAD SSI, ESPRI) : collection sheet",[9],[23],{"name":24,"affiliation":5,"role":25},"Damien SÈNE","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Damien SÈNE, MD, PhD","CONTACT","+33149956380","damien.sene@aphp.fr",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Département de Médecine Interne - Hôpital Lariboisière","RECRUITING","Paris","75010","France","FR",{"type":41,"coordinates":42},"Point",[43,44],2.3488,48.85341,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[51],{"name":52,"class":53},"LFB BIOMEDICAMENTS","UNKNOWN","100324827","medico-economic-and-quality-of-life-impact-of-sjogren-associated-small-fiber-neuropathy-100324827",false,"NCT03509064","Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy","The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)","SFINESS-QoLEco","Inclusion Criteria:\n\n* Definite primary Sjögren syndrome\n* Age over 18 years\n* No biologics nor immunoglobulin therapy during the 6 months before study onset\n\nArm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality\n\n* (i) Clinical signs of small fibers involvement: thermo-algic sensory deficit or autonomic dysfunction or neuropathic pain with DN4 ≥4;\n* AND\n* (ii) Small fibers neurophysiological abnormalities (QST, laser evoked potentials, autonomic nervous system tests (sympathetic skin response test or Sudoscan®)\n* OR\n* (iii) abnormal intraepidermal nerve fiber density (skin biopsy)\n\nArm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)\n\nExclusion Criteria:\n\n* Presence of other causes of peripheral neuropathy\n\n  * Acquired: Diabetes, AL amyloidosis, Alcoholism, celiac disease, Drugs, toxic, HIV, Sarcoidosis, systemic vasculitis, Guillain-Barré syndrome.\n  * Hereditary: Transthyretin hereditary amyloidosis (TTR), hereditary sensory and autonomic neuropathy (HSAN), Fabry's disease\n* Patients with impaired thermo-algic sensitivity and \u002F or dysautonomia and \u002F or pain with DN4 ≥ 4 AND normal diagnostic tests (normal neurophysiological tests AND normal skin biopsy) are excluded.","ALL","18 Years",{"count":65,"type":66},100,"ESTIMATED","OBSERVATIONAL","BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects women (90%) between 40 and 60 years of age and main manifestations are generalized sicca syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is associated with peripheral neuropathies, and the most common form is painful small fiber neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%), numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also autonomic disorders (50 to 70%).\n\nHowever, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on:\n\n* The impact of SFN on the quality of life of patients with Sjögren's syndrome.\n* The medico-economic impact of the SFN taking into account the repercussions on the quality of life, including professional life, usual care cost (analgesics, medical and paramedical consultations, hospitalizations or emergency).\n\nEXPECTED RESULTS\n\n* Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN\n* Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment.\n* Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.",[70,71,72,73],"Primary Sjögren Syndrome","Small Fiber Neuropathy","Quality of Life","Medico-economic Impact",[75,76,77,78],"Primary sjogren syndrome","Small fiber neuropathy","Quality of life","Medico-economic impact","2026-02-04",{"date":81,"type":82},"2026-02-05","ACTUAL",{"date":84,"type":82},"2019-01-14",{"date":86,"type":66},"2027-01-14",{"name":5,"class":6},1]