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

NCT04695288 | Completed

• 1 other identifier: 01/12/2020-297
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Kinesiophobia; Cognitive Dysfunction

Keywords

Fibromyalgia; Kinesiophobia; Cognition; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Visual Analogue scale

  1 year

• Fibromyalgia Impact Questionnaire

  1 year

• Short Form-36

  1 year

• International Physical Activity Questionnaire-Short Form

  1 year

• Hospital Anxiety/ Depression Questionnaire

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Fibromyalgia Syndrome participants and healthy volunteers.

You may qualify if:

• Fibromyalgia Syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, Turkey (Türkiye)

Location

Related Publications (6)

• Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21.

  PMID: 16078356 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.

  PMID: 17043464 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.

  PMID: 15363867 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.

  PMID: 32851370 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.

  PMID: 15556826 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.

  PMID: 24481649 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Kinesiophobia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 5, 2021
• Study Start: January 1, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)