The Relationship Between Fibromyalgia Syndrome Parameters With Disease-Pain Severity and the Quality Of Life

Completed

• Conditions: Depressive Disorder; Anxiety Disorders; Fibromyalgia Syndrome

• Registration Number: NCT05850442
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

In this study, the investigators aim to evaluate the relationship between disease severity, quality of life, anxiety and pain level in patients diagnosed with Fibromyalgia Syndrome (FMS) with the parameters according to the American College of Rheumatology (ACR) 2016 diagnostic criteria. According to the 2016 ACR diagnostic criteria, there are 2 separate scales: Widespread Pain Index (WPI) and Symptom Severity (SS) . The relationship between these 2 parameters and the Fibromyalgia Impact Questionnaire, the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire will be examined.

Detailed Description

The aim of this study is to observe the relationship between the WPI and SS parameters in the ACR 2016 criteria for fibromyalgia, separately, with the severity of the disease, pain level, quality of life and anxiety level. Accordingly, the investigators aim to evaluate whether WPI or SS has priority in assessing the severity of the disease. There is no study in the literature comparing the importance of the 2016 ACR diagnostic parameters on the disease effect. In this context, this study will be the first study in the literature and will be very valuable. Patients visiting the outpatient clinic with FMS diagnosis will be evaluated. Patients will be asked to fill the World Health Organization Short Quality of Life Questionnaire, and the McGill Melzack Pain Questionnaire and Beck Anxiety Questionnaire . The patients will be assed by an experienced Physical Medicine and Rehabilitation specialist for SS and WPI scores.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria

• History of Malignity
• History of Rheumatological Disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom Severity Score	at the start of the study	Symptom Severity Score. Ranging from 0-12. Higher scores mean higher symptom scores.
Widespread Pain Index Score	at the start of the study	Widespread Pain Index Score, Ranging from 0-19. Higher scores mean higher pain scores.

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Score	at the start of the study	Beck Anxiety Score, Ranging from 0-63. Higher scores mean anxiety getting worse.
WHO Short Quality of Life Score	at the start of the study	WHO Short Quality of Life Score, Ranging from 0-100. Higher scores mean better quality of life.

Trial Locations

Locations (1)

Özlem Kaleoğlu; 🇹🇷 Istanbul, Üsküdar, Turkey