Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

NCT ID: NCT05380804

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-02-28

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

cutaneous silent period (CSP) measurement

Intervention Type: 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

Cutaneous silent period measurement was also performed in healthy population.

cutaneous silent period (CSP) measurement

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ozge Kenis-Coskun, MD

Role: STUDY_DIRECTOR

Marmara University

Locations

Marmara University Pendik Education and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2021.111

Identifier Type: -

Identifier Source: org_study_id