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Clinical Trials/NCT05850442
NCT05850442
Completed
Not Applicable

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

Umraniye Education and Research Hospital1 site in 1 country130 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia Syndrome
Sponsor
Umraniye Education and Research Hospital
Enrollment
130
Locations
1
Primary Endpoint
Symptom Severity Score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Umraniye Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Özlem Kaleoğlu, MD

Principle Investigator

Umraniye Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria

  • History of Malignity
  • History of Rheumatological Disease

Outcomes

Primary Outcomes

Symptom Severity Score

Time Frame: at the start of the study

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

Widespread Pain Index Score

Time Frame: at the start of the study

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

Secondary Outcomes

  • Beck Anxiety Score(at the start of the study)
  • WHO Short Quality of Life Score(at the start of the study)

Study Sites (1)

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