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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05850442

Enrollment

130

Registered

2023-05-09

Start date

2023-04-01

Completion date

2024-12-01

Last updated

2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depressive Disorder, Fibromyalgia Syndrome

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.

Interventions

DIAGNOSTIC_TESTQuestionary

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Diagnosed as FMS according to ACR 2016 criterias

Exclusion criteria

* History of Malignity * History of Rheumatological Disease

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026