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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850442
• Other study ID #: B.10.1.THK.4.34.H.GP.0.01/121
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria:

• History of Malignity

• History of Rheumatological Disease

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Özlem Kaleoglu	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Widespread Pain Index Score	Widespread Pain Index Score, Ranging from 0-19. Higher scores mean higher pain scores.	at the start of the study
Primary	Symptom Severity Score	Symptom Severity Score. Ranging from 0-12. Higher scores mean higher symptom scores.	at the start of the study
Secondary	Beck Anxiety Score	Beck Anxiety Score, Ranging from 0-63. Higher scores mean anxiety getting worse.	at the start of the study
Secondary	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