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

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    100
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 5 September 2021
analgesics
skin biopsy
numbness

Summary

BACKGROUND Sjgren'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, Sjgren'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 Sjgren's syndrome.
  • 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).

EXPECTED RESULTS

  • Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN
  • Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment.
  • Evaluation of the cost attributed to the presence of an SFN in patients with Sjgren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.

Description

Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjgren's syndrome and small fiber neuropathy (SFN).

Secondary objectives :

  1. Hospital, drug and city-care costs
  2. Distribution of cost items
  3. Part of costs attributable to pSS-associated SFN
  4. Loss of quality of life attributable to pSS-associated SFN
  5. Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
  6. Association of the EQ 5D and other questionnaires with the costs (part of the costs variance that might be explained by the quality of life).

PATIENTS AND METHODS / Study population

Monocentric study in the Department of Internal Medicine of Lariboisire Fernand Widal Hospital.

All included patients fulfilled 2002-criteria of primary Sjogren syndrome.

Patients are classified into 2 arms:

Arm1: patients with Sjgren's syndrome and definite SFN

Arm2 ( Control Group) : patients with Sjgren'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 Sjgren's syndrome:

  • SF-36 for quality of life,
  • DN4 questionnaire to estimate the probability of neuropathic pain
  • EQ5D Health questionnaire
  • ESSPRI (4 questions): Sjogren-patient questionnaire
  • PROFAD-SSI (19 questions), to assess tiredness, discomfort, pain and dryness symptoms associated with Sjgren's syndrome.
  • The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months

Details
Condition Peripheral Neuropathy, Quality of life, Small Fiber Neuropathy, Primary Sjögren Syndrome, Medico-economic Impact, Primary Sjögren Syndrome, Medico-economic Impact, Primary Sjögren Syndrome, Medico-economic Impact, quality-of-life, Primary Sjögren Syndrome, Medico-economic Impact, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Medico-economic Impact, Medico-economic Impact, Primary Sjögren Syndrome, Medico-economic Impact
Treatment Collection sheet
Clinical Study IdentifierNCT03509064
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Definite primary Sjgren 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-Barr 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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