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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:
EXPECTED RESULTS
Full description
Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjögren's syndrome and small fiber neuropathy (SFN).
Secondary objectives :
PATIENTS AND METHODS / Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Patients are classified into 2 arms:
Arm1: patients with Sjögren's syndrome and definite SFN
Arm2 ( Control Group) : patients with Sjögren's syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires (collection sheet) in chronic diseases, pains or Sjögren's syndrome:
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Inclusion criteria
Arm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality
Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)
Exclusion criteria
Presence of other causes of peripheral neuropathy
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.
100 participants in 2 patient groups
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Central trial contact
Damien SÈNE, MD, PhD
Data sourced from clinicaltrials.gov
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