Sjogren's SyndromeNCT05115487
Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome
An observational study of Sjogren's Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- digital dynamometer
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 7 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with newly diagnosed primary Sjögren's syndrome according to 2016 ACR/EULAR primary Sjögren classification criteria
Who may be able to join
- 1. Patients aged 18-65 years diagnosed with Primary Sjogren's 2. Patients with normal cognitive functions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University
Konya
Suleyman akgol
About this study
Official title: Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome Patients; A Controlled Cross-sectional Study
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.
Read more
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
- Being tested
- digital dynamometer
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital dynamometerDiagnostic test
Also called ultrasonography
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: digital dynamometer | |
| Healthy controls | Not described Receives: Diagnostic Test: digital dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength will be measured by digital dynamometer
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Oct 2021
- Primary completion7 Dec 2022 (estimated)
- Study completion7 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Akgol, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115487
- Sponsor's protocol ID
- SJOGRENHAND
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome Patients; A Controlled Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05115487
- Acronym / sponsor ID
- SJOGRENHAND
- Conditions
- Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 7 Dec 2022 (estimated)
- Study completion
- 7 May 2023 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sjögren's syndrome | – | Diagnostic Test: digital dynamometerSubjects diagnosed with primary sjögren's syndrome according to the 2016 ACR/EULAR primary sjögren classification criteria will be included in the study. |
| Healthy controls | – | Diagnostic Test: digital dynamometer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed primary Sjögren's syndrome according to 2016 ACR/EULAR primary Sjögren classification criteria
Key inclusion criteria (1 listed)
- 1. Patients aged 18-65 years diagnosed with Primary Sjogren's 2. Patients with normal cognitive functions
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital dynamometerAlso: ultrasonographyHand 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. | Diagnostic test | Healthy controls, Sjögren's syndrome |
Primary outcome
Hand grip strength
Time frame: 1.5 years
Hand grip strength will be measured by digital dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suleyman AKGOL (+90332 241 50 00, slmakgol07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.