Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome
NCT ID: NCT04695288
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2021-01-01
2022-07-25
Brief Summary
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Detailed Description
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The aims of this study are:
1. To compare the kinesiophobia and cognitive functions in Fibromyalgia Syndrome with healthy volunteers
2. To examine the relationship between the severity of kinesiophobia, cognitive functions, disease activity, quality of life, physical activity level, depression and anxiety severity in Fibromyalgia Syndrome.
The hypothesis is, the patients diagnosed with Fibromyalgia Syndrome have higher kinesiophobia severity and worse cognitive functions, and also that kinesiophobia severity is associated with cognitive dysfunction, disease severity, physical activity level, and psychiatric symptoms in patients with Fibromyalgia Syndrome.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Fibromyalgia Syndrome
100 participants with a diagnosis of Fibromyalgia Syndrome according to the 2016 revised American College of Rheumatology diagnostic criteria.
No interventions assigned to this group
Control subjects
60 healthy participants do not meet the exclusion criteria of the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inflammatory rheumatic disease
* Malignancy
* Psychiatric disease
* Alcohol/substance addiction
* Central nervous system disease
* History of head trauma
* Chronic pain conditions other than Fibromyalgia Syndrome
18 Years
45 Years
FEMALE
Yes
Sponsors
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Bozyaka Training and Research Hospital
OTHER
Responsible Party
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Şeniz Akçay
Study Director
Principal Investigators
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Elcin Ergez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Seniz Akcay, Assoc Prof
Role: STUDY_DIRECTOR
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Nesibe Dogan, Specialist
Role: STUDY_CHAIR
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Dursun Hakan Delibas, Specialist
Role: STUDY_CHAIR
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Locations
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University of Health Sciences Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar, Turkey (Türkiye)
Countries
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References
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Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21.
Katz RS, Heard AR, Mills M, Leavitt F. The prevalence and clinical impact of reported cognitive difficulties (fibrofog) in patients with rheumatic disease with and without fibromyalgia. J Clin Rheumatol. 2004 Apr;10(2):53-8. doi: 10.1097/01.rhu.0000120895.20623.9f.
Denison E, Asenlof P, Lindberg P. Self-efficacy, fear avoidance, and pain intensity as predictors of disability in subacute and chronic musculoskeletal pain patients in primary health care. Pain. 2004 Oct;111(3):245-252. doi: 10.1016/j.pain.2004.07.001.
KoCyIGIt BF, Akaltun MS. Kinesiophobia Levels in Fibromyalgia Syndrome and the Relationship Between Pain, Disease Activity, Depression. Arch Rheumatol. 2020 Feb 7;35(2):214-219. doi: 10.46497/ArchRheumatol.2020.7432. eCollection 2020 Jun.
Turk DC, Robinson JP, Burwinkle T. Prevalence of fear of pain and activity in patients with fibromyalgia syndrome. J Pain. 2004 Nov;5(9):483-90. doi: 10.1016/j.jpain.2004.08.002.
Russek L, Gardner S, Maguire K, Stevens C, Brown EZ, Jayawardana V, Mondal S. A cross-sectional survey assessing sources of movement-related fear among people with fibromyalgia syndrome. Clin Rheumatol. 2015 Jun;34(6):1109-19. doi: 10.1007/s10067-014-2494-5. Epub 2014 Jan 31.
Other Identifiers
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01/12/2020-297
Identifier Type: -
Identifier Source: org_study_id
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