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

Sponsor
Selcuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05115487
Collaborator
(none)
128
1
18.7
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: digital dynamometer

Study Design

Study Type:
Observational
Anticipated Enrollment :
128 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome Patients; A Controlled Cross-sectional Study
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Dec 7, 2022
Anticipated Study Completion Date :
May 7, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • ultrasonography
  • Healthy controls

    Diagnostic Test: 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.
    Other Names:
  • ultrasonography
  • Outcome Measures

    Primary Outcome Measures

    1. Hand grip strength [1.5 years]

      Hand grip strength will be measured by digital dynamometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Selcuk University Konya Turkey

    Sponsors and Collaborators

    • Selcuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suleyman Akgol, M.D., Selcuk University
    ClinicalTrials.gov Identifier:
    NCT05115487
    Other Study ID Numbers:
    • SJOGRENHAND
    First Posted:
    Nov 10, 2021
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2021