Fatigue in Primary Sjögren's Syndrome

Bursa Yüksek İhtisas Education and Research Hospital

Status: Completed

Conditions: Fibromyalgia; Sjogren's Syndrome; Pain Syndrome; Depression; Anxiety; Fatigue

Treatments: Other: ESSDAI; Other: ESSPRI; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: FACT-F questionnaire; Other: Pain Detect Questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Insomnia severity index.

Study type: Observational

Funder types: Other

Identifiers

NCT04802577

2011-KAEK-25 2020/12-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Primary Sjögren's syndrome

Description:

The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria

Treatment:

Diagnostic Test: FACT-F questionnaire

Other: ESSDAI

Other: ESSPRI

Diagnostic Test: Beck Depression Inventory

Diagnostic Test: Insomnia severity index.

Diagnostic Test: Beck Anxiety Inventory

Other: Pain Detect Questionnaire

Healthy Controls

Description:

Healthy hospital workers without any chronic disease

Treatment:

Diagnostic Test: FACT-F questionnaire

Diagnostic Test: Beck Depression Inventory

Diagnostic Test: Insomnia severity index.

Diagnostic Test: Beck Anxiety Inventory

Other: Pain Detect Questionnaire