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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Anxiety Disorders; Fibromyalgia Syndrome
• Intervention / Treatment: Diagnostic test: Questionary

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 Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34000
      • Recruiting
      • Özlem Kaleoğlu
      • Contact: Özlem Kaleoğlu; Phone Number: 05321598018; Email: ozlemkaleoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with FMS according to ACR 2016 criteria

Description

Inclusion Criteria:

• Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria:

• History of Malignity
• History of Rheumatological Disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients will be asked to fill Fibromyalgia Impact Questionary, WHO Short Quality of Life Questionary, McGill Pain Questionary and Beck Anxiety Questionary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Depressive Disorder; Syndrome; Anxiety Disorders; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: B.10.1.THK.4.34.H.GP.0.01/121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No