Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

NCT05380804 | Completed

• 1 other identifier: 09.2021.111
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Fiber Neuropathy; Primary Sjögren Syndrome

Keywords

Small Fiber Neuropathy; Primary Sjögren Syndrome; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity

  At baseline

• Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.

  At baseline

• Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.

  At baseline

• Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain

  At baseline

• Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization

  At baseline

Study Arms (2)

Patients with primary Sjögren's syndrome

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.

Diagnostic Test: cutaneous silent period (CSP) measurement

Healthy population

Cutaneous silent period measurement was also performed in healthy population.

Diagnostic Test: cutaneous silent period (CSP) measurement

Interventions

cutaneous silent period (CSP) measurement DIAGNOSTIC_TEST

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.

Healthy population; Patients with primary Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population composed of two groups: the patient group including the participants diagnosed with pSS in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria and the control group including the healthy participants.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Education and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Small Fiber Neuropathy; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozge Kenis-Coskun, MD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: May 19, 2022
• Study Start: January 4, 2021
• Primary Completion: January 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

TU (1)