Pain Severity in Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

The Effects Pain Severity on Individuals With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481086
• Other study ID #: Fibromyalgia pain insenty
• Status: Completed
• Start date: August 15, 2022
• Est. completion date: October 28, 2023

Study information

• Verified date: November 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 28, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes
• Pain
• Pain, Chronic

Intervention

Other:
• No Interventions
There is no interventions in this study

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Tampa Kinesiophobia Scale	"Tampa Kinesiophobia Scale (TKS)" will be used to evaluate kinesiophobia. The Turkish version was created by Yilmaz et al (7). The scale consists of 17 questions developed to measure the fear of movement and/or re-injury.	10 minutes
Primary	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 Saraçoglu et al (UWCAP-TR-6). "UWCAP-TR-6" consists of 6 questions.	5 minutes
Secondary	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