Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Relationship Between Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695288
• Other study ID #: 01/12/2020-297
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: August 2022
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Fibromyalgia
• Kinesiophobia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Turkey	University of Health Sciences Izmir Bozyaka Training and Research Hospital	Izmir	Karabaglar

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Denison E, Åsenlöf 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. — View 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. — View Citation

KoÇyIGIt 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. — View Citation

Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21. Review. Erratum in: J Rheumatol Suppl. 2005 Oct;32(10):2063. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Fibromyalgia Impact Questionnaire	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
Secondary	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
Secondary	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
Secondary	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