Skip to main content
OpenTrials
Completed

NCT Number: NCT05380804

Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Small Fiber Neuropathy Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Primary Sjögren Syndrome Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Education and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparing the prevalence of the small fiber neuropathy in both groups

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.