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NCT Number: NCT07544394

Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study

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.

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Key information

About this study

This prospective longitudinal study aims to investigate predictors of fatigue and its associations with clinical and biopsychosocial factors in patients with Sjögren's disease.

The study will be conducted in the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Adult patients diagnosed with Sjögren's disease and followed in routine clinical care will be included.

Baseline assessments will include demographic and clinical data collection from medical records and routine laboratory tests. In addition, participants will undergo evaluation of pain sensitivity using pressure pain threshold (PPT) measurement and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity.

Follow-up assessments will be performed approximately 3 months later and all baseline measurements will be repeated.

The primary aim of the study is to evaluate whether baseline clinical and biopsychosocial variables explain variations in fatigue over time. Secondary aims include examining the associations between fatigue and pain sensitivity, psychological status, sleep quality, and physical activity levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Sjögren's syndrome
  • Age ≥ 18 years
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Presence of severe somatic or psychiatric disorders
  • Presence of malignancy
  • Pregnancy
  • Refusal to participate or inability to provide written informed consent

Treatment and study plan

Primary outcomes

  1. Multidimensional Fatigue Inventory-20 (MFI-20)

    Time frame: Baseline and 3-month

    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.

Secondary outcomes

  1. EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)

    Time frame: Baseline and 3-month

    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.

  2. EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

    Time frame: Baseline and 3-month

    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.

  3. Pressure Pain Threshold (PPT)

    Time frame: Baseline and 3-month

    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.

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and 3-month

    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.

  5. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline and 3-month

    The PCS is a 13-item self-report questionnaire assessing catastrophic thinking related to pain. Each item is rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 52. Higher scores indicate greater levels of pain catastrophizing. The scale includes three subdomains: rumination, magnification, and helplessness.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 3-month

    The PSQI is a 19-item self-reported questionnaire assessing sleep quality over the past month. It generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The instrument evaluates seven components including sleep quality, latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction.

  7. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Time frame: Baseline and 3-month

    The IPAQ-SF is a 7-item questionnaire assessing physical activity levels over the last 7 days, including walking, moderate-intensity, and vigorous-intensity activities. Total physical activity is expressed as MET-minutes per week. Higher scores indicate higher levels of physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Nazli Elif Nacar, phd

CONTACT

[email protected]

+90 344 40 85

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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