The Role of Central Sensitization on Biopsychosocial Factors in Primary Sjögren's Syndrome

NCT06410742 | Completed

• 1 other identifier: Kahramanmaras.SU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour. In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. Evaluations of the healthy group will be made once by the researchers and will take approximately one hour. Data will be collected face to face at the Faculty of Physical Therapy and Rehabilitation, Rheumatology Unit. Data collection tool of the research:

• Information about patients will be recorded with the Demographic Information Form.
• EULAR Sjögren's Syndrome Disease Activity Index
• EULAR Sjögren's Syndrome Patient Reporting Index
• Primary Sjögren's Syndrome Quality of Life Scale
• BETY-Biopsychosocial Questionnaire
• Central Sensitization Scale
• Pain Catastrophizing Scale
• Hospital Anxiety and Depression Scale
• Multidimensional Fatigue Rating Scale
• Turkish Eating Assessment Tool
• Yale Swallow Protocol
• Test of Mastication and Swallowing Solids
• Dysphagia Limit Test
• Xerostomia inventory

Conditions

Sjogren's Syndrome

Keywords

Sjogren' Syndrome; correlation; xerostomia; dryness

Outcome Measures

Primary Outcomes (7)

• BETY-Biopsychosocial Questionnaire (BETY-BQ)

  BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.

  baseline

• Turkish Eating Assessment Tool

  Turkish Eating Assessment Tool is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered as suspicion of aspiration.

  baseline

• Xerostomia inventory

  The scale consists of 11 items. Patients will be asked to choose the best response for each item describing their symptoms over the previous two weeks. Responses are scored from 1 to 5 (1: never, 2: rarely, 3: occasionally, 4: fairly often, and 5: very often). The sum of the item scores gives a total score ranging from 11 to 55, and a higher score indicates that the symptoms are more severe.

  baseline

• Multidimensional Fatigue Rating Scale

  This scale evaluates fatigue with 16 items under 5 subheadings: degree, severity, impact on daily activities, troubles it causes, and fatigue time. The score ranges from 0 (not tired) to 50 (extremely tired).

  baseline

• Hospital Anxiety and Depression Scale (HADS)

  In this scale consisting of fourteen questions, odd-numbered questions questioning anxiety, and even questions question depression. Options range from 0 to 3, with a higher score indicating a poor emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale.

  baseline

• Test of Mastication and Swallowing Solids

  In our study, the Test of Masticating and Swallowing Solids (TOMASS) will be used. The test evaluates how many bites the individual takes to eat a biscuit while sitting upright, how many chewing cycles he makes, how many times he swallows it, and how long the total time is from biting to swallowing. Video recording will be taken during the test. The number of bites, number of chewing cycles, number of swallows and total time will be calculated on the video.

  baseline

• Dysphagia limit

  While evaluating dysphagia, individuals are given 5, 10, 15, 20, 25, 30, 35, 40 and 45 mL volumes of liquid, respectively, with a graduated syringe and are asked to swallow the liquid. The maximum amount of fluid that the thyroid cartilage can swallow during a single movement is determined. The normal dysphagia limit in healthy individuals is more than 20 mL. If a person can swallow 20 mL normally, the dysphagia limit is normal.

  baseline

Secondary Outcomes (6)

• Central Sensitization Scale

  baseline

• Pain Catastrophizing Scale

  baseline

• EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)

  baseline

• EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)

  baseline

• Primary Sjögren's Syndrome Quality of Life Scale

  baseline

Study Arms (1)

Patients with primer Sjogren's syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals diagnosed with primary Sjögren's Syndrome according to the American European Consensus Criteria in Hacettepe University, Faculty of Medicine, Rheumatology Department, and volunteers to participate in the study will recruit this study. The total number of individuals to be included in the study will be calculated with 80% power and 95% confidence interval with the data obtained after the pilot study.

You may qualify if:

• Patients diagnosed with Primary Sjögren's Syndrome
• years or older

You may not qualify if:

• Patients with Secondary Sjögren's Syndrome,
• Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
• Having a malignant condition,
• Pregnant individuals in the third trimester,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Nazli Elif Nacar

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 13, 2024
• Study Start: June 19, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)