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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia Syndrome | 100 participants with a diagnosis of Fibromyalgia Syndrome according to the 2016 revised American College of Rheumatology diagnostic criteria. | ||
| Control subjects | 60 healthy participants do not meet the exclusion criteria of the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| TAMPA Kinesiophobia Scale | The TAMPA Kinesiophobia Scale consists of 17 questions. Each question is scored between 1-4. The maximum score is 68, with high scores indicating an increased severity of kinesiophobia. A score of more than 37 indicates high severity of kinesiophobia. | 1 year |
| Montreal Cognitive Assessment Test | This test evaluates eight separate cognitive functions: Attention, working memory, short-term memory, delayed memory, visuospatial abilities, executive functioning, language, and orientation to time and place. Scores of 21 and above are considered normal, with the highest test score being 30. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue scale | The patient is asked to mark her severity of pain on a horizontal 10-cm line with number 0 on one end representing "no" and number 10 on the other end indicating "very severe pain". Higher scores indicate higher levels of pain intensity. | 1 year |
| Fibromyalgia Impact Questionnaire |
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Inclusion Criteria:
-Fibromyalgia Syndrome
Exclusion Criteria:
Fibromyalgia Syndrome is more common in women than in men. For this reason, we predicted that there might be inequality in the distribution of male/female in the participant group included.
Physical activity level and psychiatric scales may differ between genders.
Fibromyalgia Syndrome participants and healthy volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Elcin Ergez, MD | University of Health Sciences Izmir Bozyaka Training and Research Hospital | Principal Investigator |
| Seniz Akcay, Assoc Prof | University of Health Sciences Izmir Bozyaka Training and Research Hospital | Study Director |
| Nesibe Dogan, Specialist | University of Health Sciences Izmir Bozyaka Training and Research Hospital | Study Chair |
| Dursun Hakan Delibas, Specialist | University of Health Sciences Izmir Bozyaka Training and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Izmir Bozyaka Training and Research Hospital | Izmir | Karabaglar | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16078356 | Background | Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21. | |
| 17043464 | Background | 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. |
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The clinical study report will be shared at the end of the study.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D000092442 | Kinesiophobia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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It aims to evaluate the arthritis symptoms and functional status of patients with fibromyalgia syndrome through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue. Higher scores indicate greater impact of fibromyalgia on functioning. Final score should range from 0 to 80. |
| 1 year |
| Short Form-36 | Short Form-36 (SF-36) is a widely used and validated scale for evaluating the quality of life. It is not specific to any disease group. It consists of thirty six items. It consists of 8 subscales related to physical health (physical function, physical role, pain, general health) and mental health (energy, social function, emotional role difficulty, mental health) factors. Each sub-scale chart is evaluated between 0 and 100 points. Higher scores indicate good health. | 1 year |
| International Physical Activity Questionnaire-Short Form | Physical activity levels in the last 7 (seven) days will be evaluated with the International Physical Activity Questionnaire-Short form. This short form consists of seven questions and provides information about the durations of physical activities, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. | 1 year |
| Hospital Anxiety/ Depression Questionnaire | Hospital Anxiety/ Depression Questionnaire determines the risk in terms of anxiety and depression in the patient and to measure its level and severity. It is used to diagnose anxiety and depression in a short time and determine the risk group for patients with physical diseases and those who apply to primary health care. Seven (odd numbers) of 14 questions measure anxiety and seven (even numbers) measure depression. Answers are scored in a four-point Likert scale between 0 and 3. The lowest score that patients can get from both subscales is 0, the highest score is 21. | 1 year |
| 15363867 | Background | 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. |
| 32851370 | Background | 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. |
| 15556826 | Background | 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. |
| 24481649 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |