NCT05380804

Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

Comparison of Cutaneous Silent Period Parameters in Patients With Primary Sjögren's Syndrome With the Healthy Population and Determination of Its Relationship With Clinical Parameters

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Small Fiber Neuropathy
• Primary Sjögren Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cutaneous silent period (CSP) measurement	CSP recordings are performed in the upper extremities using the same surface bar recording electrodes. Filters are set at 2 Hertz (Hz) to 10 kilo Hz, sensitivity is 200 microVolts (µV) and sweep speed is set at 200 milliseconds (ms). Stimulating electrode is placed on the index finger and recording bar electrode is placed on the abductor pollicis brevis (APB) muscle. During steady submaximal (50% of the maximal contraction) thumb abduction, 10 consecutive painful electrical stimuli of standard 80-milli Ampere (mA) intensity and 0.5-ms duration are applied to the index finger and responses are superimposed. CSP latency and duration are calculated and recorded. CSP latency is defined as the time between the stimulation and the onset of the silent period. CSP duration is calculated as the time interval between the beginning and end of the CSP.

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-01-28
• Completion: 2022-02-28
• First posted: 2022-05-19
• Last updated: 2022-05-19

Locations

1 site across 1 country: Turkey (Türkiye)