Clinical trial NCT05380804: Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Fiber Neuropathy
Primary Sjögren Syndrome
Keywords: Small Fiber Neuropathy
Primary Sjögren Syndrome
Neuropathic Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Comparing the prevalence of the small fiber neuropathy in both groups
timeFrame: At baseline
Secondary outcomes:
measure: Correlation between the number of the patients with small fiber neuropathy and score of the clinical disease severity
timeFrame: At baseline
measure: Correlation between the number of the patients with small fiber neuropathy and scores of quality of life assessment.
timeFrame: At baseline
measure: Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.
timeFrame: At baseline
measure: Correlation between the number of the patients with small fiber neuropathy and number of patients with neuropathic pain
timeFrame: At baseline
measure: Correlation between the number of the patients with small fiber neuropathy and number of patients with central sensitization
timeFrame: At baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Education and Research Hospital
state: Pendik
Study officials:
affiliation: Marmara University
name: Ozge Kenis-Coskun, MD
role: STUDY_DIRECTOR
References: