Fatigue in Primary Sjögren's Syndrome

Completed

• Conditions: Pain Syndrome; Anxiety; Fatigue; Depression; Sjogren's Syndrome; Fibromyalgia
• Interventions: Diagnostic Test: FACT-F questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: Insomnia severity index.; Other: ESSPRI; Other: ESSDAI; Other: Pain Detect Questionnaire

• Registration Number: NCT04802577
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Detailed Description

While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-03-14
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-17
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
• Healthy hospital staff

Exclusion Criteria

• Pregnant women
• Cancer patients
• Those with other connective tissue diseases other than PSS
• Multiple sclerosis patients
• Chronic obstructive pulmonary disease
• Those with heart failure and adrenal insufficiency
• Those with renal failure: GFR <60 ml/min
• Anemia: Hemoglobin <11 g / dl in women, hemoglobin <12 g / dl in men
• Hypothyroidism: TSH >5 mu / L
• Those with electrolyte disturbance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Sjögren's syndrome	Beck Depression Inventory	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Primary Sjögren's syndrome	Beck Anxiety Inventory	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Primary Sjögren's syndrome	Pain Detect Questionnaire	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Healthy Controls	Pain Detect Questionnaire	Healthy hospital workers without any chronic disease
Healthy Controls	FACT-F questionnaire	Healthy hospital workers without any chronic disease
Primary Sjögren's syndrome	FACT-F questionnaire	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Primary Sjögren's syndrome	Insomnia severity index.	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Healthy Controls	Insomnia severity index.	Healthy hospital workers without any chronic disease
Primary Sjögren's syndrome	ESSPRI	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Primary Sjögren's syndrome	ESSDAI	The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria
Healthy Controls	Beck Depression Inventory	Healthy hospital workers without any chronic disease
Healthy Controls	Beck Anxiety Inventory	Healthy hospital workers without any chronic disease

Primary Outcome Measures

Name	Time	Method
FACIT-F	day 1	FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE

Secondary Outcome Measures

Name	Time	Method
BAI	day 1	Beck Anxiety Inventory
BDI	day 1	Beck Depression Inventory
PDQ	day 1	Pain Detect Questionnaire
ISS	day 1	Insomnia Severity Scale

Trial Locations

Locations (1)

Koray Ayar; 🇹🇷 Yıldırım, Bursa, Turkey