Clinical trial NCT05481086: Pain Severity in Fibromyalgia Syndrome
Official title: The Effects Pain Severity on Individuals With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Pain, Chronic
Keywords: fibromyalgia
pain
patient reported outcome measurement
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.)

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Chronic Pain Grading Scale-Revised (CPGS-R)
timeFrame: 5 minutes
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: 10 minutes
measure: Tampa Kinesiophobia Scale
timeFrame: 10 minutes
measure: UW-Concerns About Pain
timeFrame: 5 minutes
Secondary outcomes:
measure: Short form-12 (SF-12) questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
Study officials:
affiliation: Kutahya Health Sciences University
name: İSMAİL SARAÇOĞLU, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: