Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

Completed

• Conditions: Primary Sjögren Syndrome; Small Fiber Neuropathy
• Interventions: Diagnostic Test: cutaneous silent period (CSP) measurement

• Registration Number: NCT05380804
• Lead Sponsor: Marmara University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2022-01-21
• Primary Completion: 2022-01-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with primary Sjögren's syndrome	cutaneous silent period (CSP) measurement	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.
Healthy population	cutaneous silent period (CSP) measurement	Cutaneous silent period measurement was also performed in healthy population.

Primary Outcome Measures

Name	Time	Method
Comparing the prevalence of the small fiber neuropathy in both groups	At baseline	Cutaneous silent period measurements are done for detecting small fiber neuropathy in both groups. The latency and duration of CSP are recorded.

Secondary Outcome Measures

Name	Time	Method
Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain	At baseline	For assessing neuropathic pain, Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is used. CSP parameters are compared between the patients with neuropathic pain according to the LANSS and the patients without neuropathic pain. This assessment is done for only pSS group.
Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity	At baseline	For assessing clinical disease severity, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is used. The correlation between ESSPRI scores and CSP parameters is investigated. This assessment is done for only pSS group.
Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.	At baseline	For assessing quality of life, Short Form-36 (SF-36) is used. The correlation between SF-36 scores and CSP parameters is investigated. This assessment is done for only pSS group.
Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization	At baseline	For assessing central sensitization, Central Sensitization Inventory (CSI) is used. CSP parameters are compared between the patients with central sensitization according to the CSI and the patients without central sensitization. This assessment is done for only pSS group.
Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.	At baseline	For assessing mood, Hospital Anxiety and Depression Scale (HADS) is used. The correlation between HADS scores and CSP parameters is investigated. This assessment is done for only pSS group.

Trial Locations

Locations (1)

Marmara University Pendik Education and Research Hospital; 🇹🇷 Istanbul, Pendik, Turkey