Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome

• Conditions: Sjogren's Syndrome
• Interventions: Diagnostic Test: digital dynamometer

• Registration Number: NCT05115487
• Lead Sponsor: Selcuk University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10
• Primary Completion: 2022-12-07
• Study Completion: 2023-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 1. Patients aged 18-65 years diagnosed with Primary Sjogren's 2. Patients with normal cognitive functions

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Exclusion Criteria

• 1. Other connective tissue diseases other than primary Sjögren's 2.Pregnancy 3.Malignancy 4. Chronic diseases (DM, HT, Hypothyroidism, hyperthyroidism) 5. Cognitive disorder 6. Neurological or traumatic hand disorders leading to hand disorders (MS, Trauma, SVO) 7. 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sjögren's syndrome	digital dynamometer	Subjects diagnosed with primary sjögren's syndrome according to the 2016 ACR/EULAR primary sjögren classification criteria will be included in the study.
Healthy controls	digital dynamometer	-

Primary Outcome Measures

Name	Time	Method
Hand grip strength	1.5 years	Hand grip strength will be measured by digital dynamometer

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Turkey