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

NCT ID: NCT05115487

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2023-05-07

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.

Conditions

Sjogren's Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sjögren's syndrome

Subjects diagnosed with primary sjögren's syndrome according to the 2016 ACR/EULAR primary sjögren classification criteria will be included in the study.

digital dynamometer

Intervention Type: DIAGNOSTIC_TEST

Hand grip strength will be measured using a hand-held digital dynamometer with the patient sitting in a hard chair and elbow flexed to 90°. All assessments and measurements will be made by the same experienced physician blinded to patients' clinical data.

Healthy controls

digital dynamometer

Intervention Type: DIAGNOSTIC_TEST

Hand grip strength will be measured using a hand-held digital dynamometer with the patient sitting in a hard chair and elbow flexed to 90°. All assessments and measurements will be made by the same experienced physician blinded to patients' clinical data.

Interventions

digital dynamometer

Hand grip strength will be measured using a hand-held digital dynamometer with the patient sitting in a hard chair and elbow flexed to 90°. All assessments and measurements will be made by the same experienced physician blinded to patients' clinical data.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ultrasonography

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Suleyman Akgol

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Selcuk University

Konya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Suleyman AKGOL

Role: CONTACT

Phone: +90332 241 50 00

Email: slmakgol07@gmail.com

Facility Contacts

Suleyman akgol

Role: primary

Other Identifiers

SJOGRENHAND

Identifier Type: -

Identifier Source: org_study_id