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

NCT05115487 | Unknown

• 1 other identifier: SJOGRENHAND
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hand grip strength

  Hand grip strength will be measured by digital dynamometer

  1.5 years

Study Arms (2)

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.

Diagnostic Test: digital dynamometer

Healthy controls

Diagnostic Test: digital dynamometer

Interventions

digital dynamometer 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.

Also known as: ultrasonography

Healthy controls; Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed primary Sjögren's syndrome according to 2016 ACR/EULAR primary Sjögren classification criteria

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Suleyman AKGOL

CONTACT

+90332 241 50 00; slmakgol07@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 10, 2021
• Study Start: October 15, 2021
• Primary Completion: December 7, 2022
• Study Completion: May 7, 2023
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

TU (1)