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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Comparing the prevalence of the small fiber neuropathy in both groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparing the prevalence of the small fiber neuropathy in both groups
时间窗: At baseline
Cutaneous silent period measurements are done for detecting small fiber neuropathy in both groups. The latency and duration of CSP are recorded.
次要结局
- 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 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 number of patients with central sensitization(At baseline)
- Correlation between the number of the patients with small fiber neuropathy and scores of mood assessments.(At baseline)