Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKahramanmaras Sutcu Imam University
About this trial
This prospective longitudinal study will be conducted in patients diagnosed with Sjögren's disease who are followed at the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Demographic and clinical data will be collected from routine clinical assessments and medical records, including laboratory results obtained during standard care.
Participants will undergo evaluation of pressure pain threshold using a digital algometer and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity level.
All assessments will be performed at baseline and repeated at follow-up visits approximately 3 months later.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Sjögren's syndrome
Age ≥ 18 years
Willingness to participate and provide written informed consent
Disqualifiers
Presence of severe somatic or psychiatric disorders
Presence of malignancy
Pregnancy
Refusal to participate or inability to provide written informed consent
Trial population
Participants will be recruited from the rheumatology outpatient clinics of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. The study population will consist of adult patients diagnosed with Sjögren's disease who are followed in routine clinical care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Multidimensional Fatigue Inventory-20 (MFI-20)
The MFI-20 is a 20-item self-reported questionnaire assessing fatigue across five dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each item is scored on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater fatigue.
Time frame
Baseline and 3-monthSecondary outcomes
1
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI is a clinician-reported index assessing systemic disease activity in Sjögren's syndrome across multiple domains including constitutional, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, and biological features. Higher scores indicate greater disease activity.
Time frame
Baseline and 3-month2
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
ESSPRI is a patient-reported outcome measure evaluating fatigue, pain, and dryness using a 0-10 numerical rating scale. The final score is calculated as the mean of the three domains. Higher scores indicate worse symptom severity.
Time frame
Baseline and 3-month3
Pressure Pain Threshold (PPT)
PPT will be assessed using a digital pressure algometer applied at a constant rate of 50 kPa/s with a 1 cm² probe. Measurements will be taken bilaterally at predefined anatomical sites (trapezius muscle, thumb nail base, and knee). The mean of three consecutive measurements at each site will be recorded. A global PPT value will be calculated by averaging all sites. Higher values indicate lower pain sensitivity.
Time frame
Baseline and 3-month4
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item self-report questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater psychological distress.
Time frame
Baseline and 3-monthSponsors and contacts
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Source ClinicalTrials.gov