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临床试验/NCT05115487
NCT05115487Unknown不适用

Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome Patients; A Controlled Cross-sectional Study

Selcuk University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
128
试验地点
1
主要终点
Hand grip strength

研究概览

简要总结

Hand functions are decreased in rheumatic diseases such as systemic sclerosis and rheumatoid arthritis.

Sjögren's syndrome (SS) is a chronic systemic rheumatic disease characterized by lymphoplasmacytic infiltration of exocrine glands, especially salivary and lacrimal glands.

SS may be "primary" when it occurs alone (pSS) and "secondary" (sSS) when associated with another autoimmune disease. PSS is the most common connective tissue disease after rheumatoid arthritis and affects 0.3-3% of the population. Joint involvement is the most common involvement of pSS after sicca syndrome (50% of patients). Patients may have arthralgia with inflammatory features (morning stiffness > 30 minutes) or, less frequently, true symmetric polysynovitis mimicking rheumatoid arthritis (RA). The joint involvement of PSS is usually moderate (<5 affected joints) and mostly affects the small joints of the hands and upper extremities. PSS may also be responsible for myositis. Widespread pain, similar to primary fibromyalgia, is common in about 50 percent of patients with PSS.

The hand is one of the most important components affecting the functionality of the upper extremity. Grasping is one of the hand functions, for the continuity of daily living activities.

is an important function. Studies have shown that hand grip strength is correlated with upper extremity muscle strength, as well as general body muscle strength and pulmonary muscle strength.

As far as we know, hand functions have not been evaluated in newly diagnosed patients with pSS.

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

入选标准

  • Patients aged 18-65 years diagnosed with Primary Sjogren's
  • Patients with normal cognitive functions

排除标准

  • Other connective tissue diseases other than primary Sjögren's 2.Pregnancy 3.Malignancy
  • Chronic diseases (DM, HT, Hypothyroidism, hyperthyroidism)
  • Cognitive disorder
  • Neurological or traumatic hand disorders leading to hand disorders (MS, Trauma, SVO)
  • Patients who have undergone major salivary gland surgery, have Graft Versus Host disease, have received Sarcoidosis, Head and Neck Radiotherapy, have a history of HTLV-1 or HIV

结局指标

主要结局

Hand grip strength

时间窗: 1.5 years

Hand grip strength will be measured by digital dynamometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suleyman Akgol

M.D.

Selcuk University

研究点 (1)

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