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

Sponsor

Umraniye Education and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05850442

Collaborator

(none)

130

Enrollment

Location

Anticipated Duration (Months)

43.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, we 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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome Anxiety Disorders Depressive Disorder	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, we 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 our 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 . They will be assed by an experienced Physical Medicine and Rehabilitation specialist for SS and WPI scores.

Study Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Widespread Pain Index Score [at the start of the study]
Widespread Pain Index Score
Symptom Severity Score [at the start of the study]
Symptom Severity Score

Secondary Outcome Measures

Beck Anxiety Score [at the start of the study]
Beck Anxiety Score
WHO Short Quality of Life Score [at the start of the study]
WHO Short Quality of Life Score
McGill Pain Score [at the start of the study]
McGill Pain Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosed as FMS according to ACR 2016 criterias

Exclusion Criteria:

History of Malignity
History of Rheumatological Disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Özlem Kaleoğlu	Istanbul	Üsküdar	Turkey	34000

Sponsors and Collaborators

Umraniye Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Özlem Kaleoğlu Aslan, M.D., Umraniye Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05850442

Other Study ID Numbers:

B.10.1.THK.4.34.H.GP.0.01/121

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Study Results

No Results Posted as of May 9, 2023