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

NCT05850442 | Completed

• 1 other identifier: B.10.1.THK.4.34.H.GP.0.01/121
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome; Anxiety Disorders; Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Widespread Pain Index Score

  Widespread Pain Index Score, Ranging from 0-19. Higher scores mean higher pain scores.

  at the start of the study

• Symptom Severity Score

  Symptom Severity Score. Ranging from 0-12. Higher scores mean higher symptom scores.

  at the start of the study

Secondary Outcomes (2)

• Beck Anxiety Score

  at the start of the study

• WHO Short Quality of Life Score

  at the start of the study

Study Arms (1)

FIBROMIYALGIA GROUP

Patients aged between 18-65 who are diagnosed as FMS according to AACR 2016 criterias willing to take part in the study.

Diagnostic Test: Questionary

Interventions

Questionary DIAGNOSTIC_TEST

Patients will be asked to fill Fibromyalgia Impact Questionary, WHO Short Quality of Life Questionary, McGill Pain Questionary and Beck Anxiety Questionary

FIBROMIYALGIA GROUP

Eligibility Criteria

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

Study Population

Patients diagnosed with FMS according to ACR 2016 criteria

You may qualify if:

• Diagnosed as FMS according to ACR 2016 criterias

You may not qualify if:

• History of Malignity
• History of Rheumatological Disease

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Özlem Kaleoğlu

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Mood Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)