Clinical trial NCT04695288: Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome
Official title: Relationship Between Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Kinesiophobia
Cognitive Dysfunction
Keywords: Fibromyalgia
Kinesiophobia
Cognition
Quality of life
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fibromyalgia Syndrome participants and healthy volunteers.

Brief summary: Although one of the most evidence-based treatment protocols is based on exercise strategies in patients with Fibromyalgia Syndrome, fear and avoidance of physical activity; named 'Kinesiophobia' may hinder the patients from the exercises. Cognitive dysfunctions are seen frequently in Fibromyalgia Syndrome. The aim of this study, to assess the relationship between kinesiophobia and cognitive functions, disease severity, quality of life, physical activity level, pain intensity, and anxiety/depression level in Fibromyalgia patients. Additionally, the investigators aimed to compare the kinesiophobia level and cognitive functions between patients with Fibromyalgia Syndrome and control subjects.

Detailed description: Cognitive dysfunction, including learning difficulties, memory, attention, and executive dysfunctions are frequent in fibromyalgia syndrome. Kinesiophobia is defined as fear and avoidance of physical activities, and it can lead to increased disability in patients with chronic pain. Although there is a relationship between cognitive functions and physical performance in Fibromyalgia Syndrome, the relationship between kinesiophobia, fibrofog, and quality of life are required to be investigated.

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.

Eligibility criteria: Inclusion Criteria:

-Fibromyalgia Syndrome

Exclusion Criteria:

* Education year \< 5
* Inflammatory rheumatic disease
* Malignancy
* Psychiatric disease
* Alcohol/substance addiction
* Central nervous system disease
* History of head trauma
* Chronic pain conditions other than Fibromyalgia Syndrome

Primary outcomes:
measure: TAMPA Kinesiophobia Scale
timeFrame: 1 year
measure: Montreal Cognitive Assessment Test
timeFrame: 1 year
Secondary outcomes:
measure: Visual Analogue scale
timeFrame: 1 year
measure: Fibromyalgia Impact Questionnaire
timeFrame: 1 year
measure: Short Form-36
timeFrame: 1 year
measure: International Physical Activity Questionnaire-Short Form
timeFrame: 1 year
measure: Hospital Anxiety/ Depression Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: University of Health Sciences Izmir Bozyaka Training and Research Hospital
state: Karabaglar
Study officials:
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Elcin Ergez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Seniz Akcay, Assoc Prof
role: STUDY_DIRECTOR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Nesibe Dogan, Specialist
role: STUDY_CHAIR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Dursun Hakan Delibas, Specialist
role: STUDY_CHAIR
References:
citation: Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.