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FibromyalgiaNCT04695288

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

An observational study of Fibromyalgia and Kinesiophobia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia, Kinesiophobia, Cognitive Dysfunction
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 25 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Fibromyalgia Syndrome participants and healthy volunteers.

Who may be able to join

  • -Fibromyalgia Syndrome

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • University of Health Sciences Izmir Bozyaka Training and Research Hospital

    Izmir, Karabaglar

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Keywords
Fibromyalgia, Kinesiophobia, Cognition, Quality of life
Medical subject headings
Fibromyalgia, Kinesiophobia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04695288
Study groupRoleWhat they receive
Fibromyalgia Syndrome100 participants with a diagnosis of Fibromyalgia Syndrome according to the 2016 revised American College of Rheumatology diagnostic criteria.
Control subjects60 healthy participants do not meet the exclusion criteria of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Secondary outcomes (5)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start1 Jan 2021
  3. Primary completion25 Jul 2022
  4. Study completion25 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04695288
Sponsor's protocol ID
01/12/2020-297
Status last verified
Aug 2022
First submitted
2 Jan 2021
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The clinical study report will be shared at the end of the study.

Publications

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

    PubMed 16078356

  • 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.

    PubMed 17043464

  • 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.

    PubMed 15363867

  • 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.

    PubMed 32851370

  • 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.

    PubMed 15556826

  • 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.

    PubMed 24481649

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Kinesiophobia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TAMPA Kinesiophobia Scale (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04695288, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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