Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

Small Fiber Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380804
• Other study ID #: 09.2021.111
• Status: Completed
• Start date: January 4, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Small Fiber Neuropathy
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Education and Research Hospital	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the prevalence of the small fiber neuropathy in both groups	Cutaneous silent period measurements are done for detecting small fiber neuropathy in both groups. The latency and duration of CSP are recorded.	At baseline
Secondary	Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity	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.	At baseline
Secondary	Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.	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.	At baseline
Secondary	Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.	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.	At baseline
Secondary	Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain	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.	At baseline
Secondary	Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization	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.	At baseline