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Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

M

Marmara University

Status

Completed

Conditions

Primary Sjögren Syndrome
Small Fiber Neuropathy

Treatments

Diagnostic Test: cutaneous silent period (CSP) measurement

Study type

Observational

Funder types

Other

Identifiers

NCT05380804
09.2021.111

Details and patient eligibility

About

Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. The prevalence of neurological involvement varies widely from 10% to 60% in different series.

Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in patients with pSS and has an important clinical importance because it cannot be detected by routine electrophysiological studies. Various methods can be used in the detection of SFN, and cutaneous silent period (CSP) measurement is gaining popularity recently due to its non-invasiveness and practical fashion.

In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in patients with pSS and in the healthy population and to reveal its relationship with clinical parameters.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Being between the ages of 18-65
  • For the patient group, patients followed up in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria

Exclusion criteria

  • Any comorbidities that may cause neuropathy
  • Any drugs that may cause neuropathy
  • Chronic alcohol consumption
  • A history of disease that may affect the central nervous system

Trial design

72 participants in 2 patient groups

Patients with primary Sjögren's syndrome
Description:
Cutaneous silent period measurement was performed in patients with the primary Sjögren's syndrome classified according to the 2016 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) criteria.
Treatment:
Diagnostic Test: cutaneous silent period (CSP) measurement
Healthy population
Description:
Cutaneous silent period measurement was also performed in healthy population.
Treatment:
Diagnostic Test: cutaneous silent period (CSP) measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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