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NCT Number: NCT05850442

The Relationship Between Fibromyalgia Syndrome Parameters With Disease-Pain Severity 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.

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Key information

Conditions

Fibromyalgia Syndrome Anxiety Disorders Depressive Disorder Fibromyalgia Mental Disorders Mood Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Özlem Kaleoğlu

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as FMS according to ACR 2016 criterias

Exclusion criteria

  • History of Malignity
  • History of Rheumatological Disease

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. Symptom Severity Score

    Time frame: at the start of the study

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

Secondary outcomes

  1. Beck Anxiety Score

    Time frame: at the start of the study

    Beck Anxiety Score, Ranging from 0-63. Higher scores mean anxiety getting worse.

  2. WHO Short Quality of Life Score

    Time frame: at the start of the study

    WHO Short Quality of Life Score, Ranging from 0-100. Higher scores mean better quality of life.

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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