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Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy

Recruitingn/aAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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%). However, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on: * The impact of SFN on the quality of life of patients with Sjögren's syndrome. * The med

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📋 Eligibility rules (as published)
Inclusion Criteria: * Definite primary Sjögren syndrome * Age over 18 years * No biologics nor immunoglobulin therapy during the 6 months before study onset Arm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality * (i) Clinical signs of small fibers involvement: thermo-algic sensory deficit or autonomic dysfunction or neuropathic pain with DN4 ≥4; * AND * (ii) Small fibers neurophysiological abnormalities (QST, laser evoked potentials, autonomic nervous system tests (sympathetic skin response test or Sudoscan®) * OR * (iii) abnormal intraepidermal nerve fiber density (skin biopsy) Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber) Exclusion Criteria: * Presence of other causes of peripheral neuropathy * Acquired: Diabetes, AL amyloidosis, Alcoholism, celiac disease, Drugs, toxic, HIV, Sarcoidosis, systemic vasculitis, Guillain-Barré syndrome. * Hereditary: Transthyretin hereditary amyloidosis (TTR), hereditary sensory and autonomic neuropathy (HSAN), Fabry's disease * Patients with impaired thermo-algic sensitivity and / or dysautonomia and / or pain with DN4 ≥ 4 AND normal diagnostic tests (normal neurophysiological tests AND normal skin biopsy) are excluded.
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What it tests

  • Collection sheet
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Where

1 site
Département de Médecine Interne - Hôpital Lariboisière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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