Pain Severity in Fibromyalgia Syndrome

The Effects Pain Severity on Individuals With Fibromyalgia Syndrome

Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The existence and importance of the multidimensional nature of chronic pain in FMS has been demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability, and novelty of onset are all important characteristics of a chronic pain condition. Therefore, there was a need for a global measure of chronic pain severity that summarized different measures of pain and a graded classification of chronic pain was proposed. Patients with chronic pain such as FMS are known to have a greater negative impact than many chronic medical conditions. Chronic pain severity in FMS has been found to be associated with various conditions such as function and health status, and it has been shown that reduction in pain severity provides broadly beneficial results on these conditions. However; there are no studies in which chronic pain severity in FMS is classified by grading and investigating the relationship of different pain severity degrees with disease severity and other symptoms.

The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and concerns about pain differ in individuals with different pain severity by grading the severity of pain in individuals with fibromyalgia syndrome.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Pain, Chronic
• Intervention / Treatment: Other: No Interventions

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

• Study Contact: Name: ESRA AKIN, PhD(cont.); Phone Number: +905346984874; Email: esraakin1543@hotmail.com

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants who directly presented to the Physical Therapy Department of Kutahya Health Sciences University Hospital during the study period (between 15 August and 15 Nowember) with persistent and diffuse pain, will be screened for eligibility by an independent physician (M.A.L.)

Description

Inclusion Criteria:

• to be aged between 18-65,
• to be diagnosed with fibromyalgia syndrome according to the criteria of 2016 ACR
• to be volunteer to participate in the study.

Exclusion Criteria:

• Having cognitive impairment
• Illiterate people
• Diagnosed severe mental and psychological disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Individuals with fibromyalgia syndrome	Other: No Interventions; There is no interventions in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Pain Grading Scale-Revised (CPGS-R)	Pain severity and degree will be evaluated with the "Revised Graded Chronic Pain Scale (GCPS-R)". The "Graded Chronic Pain Scale" was created by Von Korff et al (1) to evaluate the severity of pain and disability related to pain in individuals with chronic pain. It has also been revised by the same authors (2). The Turkish validity and reliability study of the GCPS-R was performed by Özden et al (3).	5 minutes
Revised Fibromyalgia Impact Questionnaire	The Fibromyalgia Impact Questionnaire was developed by Burckhardt et al (4). The scale was revised by Bennett et al (5). The Turkish validity and reliability study of the FIQ-R was performed by Ediz et al (6). The structure of the FIQ-R's original questionnaire, based on function, overall effect, and severity of FM symptoms (disease severity) is the same as in the FIQ. However, questions assessing altered function, which were not part of the original FIQ, and questions measuring cognitive impairment, sensitivity, balance, and environmental sensitivity have been added to the FIQ-R. Also, some of the wording, missings, concepts and scoring problems in the original FIQ have been corrected in the FIQ-R. FIQ-R consists of 21 questions in total.	10 minutes
Tampa Kinesiophobia Scale	"Tampa Kinesiophobia Scale (TKS)" will be used to evaluate kinesiophobia. The Turkish version was created by Yılmaz et al (7). The scale consists of 17 questions developed to measure the fear of movement and/or re-injury.	10 minutes
UW-Concerns About Pain	Participants' pain concerns will be assessed with the "University of Washington Concerns About Pain (UWCAP)", which was recently developed as a pain self-efficacy measure based on modern scale development approaches. The scale was adapted to Turkish by Saraçoğlu et al (UWCAP-TR-6). "UWCAP-TR-6" consists of 6 questions.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short form-12 (SF-12) questionnaire	Turkish Short form-12 (SF-12) questionnaire, 12-item generic self-administered instrument that consists of eight subscales relating to various aspects of the QoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health.	5 minutes

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: İSMAİL SARAÇOĞLU, Ph.D., Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; fibromyalgia; patient reported outcome measurement
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Chronic Pain; Fibromyalgia; Myofascial Pain Syndromes; Pain
• Other Study ID Numbers: Fibromyalgia pain insenty

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