- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778801
Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain
Evaluation of Kinesiophobia and Physical Activity Levels in Patients With Fibromyalgia Syndrome and Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To evaluate pain, kinesiophobia, physical activity, depression, disease severity, and fatigue in patients with fibromyalgia syndrome or chronic neck pain and healthy controls.
Design: Cross-sectional study. Setting: Tertiary Health Care Center, Aksaray, Turkey Participants: 30 patients with fibromyalgia syndrome (Group 1), 30 patients with chronic neck pain (Group 2), and 30 healthy individuals (Group 3) were included.
Main Outcome Measures: Outcome measures were Visual Analogue Scale (VAS)-pain and fatigue, Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ) Short Form, Fibromyalgia Impact Questionnaire (FIQ), Neck Pain Disability Index (NPDI).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aksaray, Turkey
- Aksaray University Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Participants with a clinical diagnosis of fibromyalgia syndrome Participants with a clinical diagnosis of chronic neck pain Healthy participants Participants with fibromyalgia syndrome and chronic neck pain has had a disease duration more than three months
Exclusion Criteria:
Malignant disease Systemic infectious disease Rheumatic disease Operation Pregnancy Psychological or cognitive disorder History of physical therapy within the last three months History of intra-articular or intra-ligamentary injection within the last three months
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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fibromyalgia syndrome
Thirty patients with a diagnosis of fibromyalgia syndrome according to the 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria and a disease duration of longer than three months
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The investigators assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
Other Names:
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chronic neck pain
30 patients with chronic neck pain lasting for more than three months and didn't meet 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria.
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The investigators assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
Other Names:
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healthy controls
30 healthy controls without pain or additional disease
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The investigators assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Beck Depression Inventory
Time Frame: 10 minutes
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This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression.
A score of 10 or higher indicates depression.
Minimal and maximal scores can be 0-63 points.
Higher scores indicate higher levels of depression.
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10 minutes
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Neck Pain Disability Index
Time Frame: 5-8 minutes
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This index consists of 20 questions that assess severity of neck pain and the extent to which the pain affects the social, professional and daily activities of patients.Final score should range from 0 to 100.
Higher scores indicate greater levels of disability.
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5-8 minutes
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Tampa Scale of Kinesiophobia
Time Frame: 4-8 minutes
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Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity.
A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia.
Minimal and maximal scores could be between 17-68 points.
Higher scores indicate higher levels of kinesiophobia.
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4-8 minutes
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International Physical Activity Questionnaire Short Form
Time Frame: 5-10 minutes
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This questionnaire consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit.
3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week are proposed to be moderate level.
Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 MET-minutes/week are proposed to be high level.
Some activity is reported but not enough to meet categories of moderate or high levels, it is proposed to be low level.
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5-10 minutes
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Fibromyalgia Impact Questionnaire
Time Frame: 5 minutes
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Fibromyalgia Impact Questionnaire 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.
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5 minutes
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Visual Analog Scale for the Evaluation of Pain
Time Frame: 0.5 minutes
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For this evaluation, the patient is asked to mark his/her severity of pain on a horizontal 100-mm line with 0 on one end representing no pain and 100 on the other end represent very severe pain.
Higher scores indicate higher levels of pain intensity.
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0.5 minutes
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Visual Analog Scale for the Evaluation of Fatigue
Time Frame: 0.5 minutes
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For this evaluation, the patient is asked to mark his/her severity of fatigue on a horizontal 100-mm line with 0 on one end representing no fatigue and 100 on the other end represent very severe fatigue.
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0.5 minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Melek A Selçuk, Aksaray University Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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