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Kinesiophobia which is described as fear of movement reduces physical activity levels and increases the risk of chronic pain. The investigators consider that kinesiophobia levels are higher in patients with fibromyalgia syndrome and chronic neck pain so that physical activity levels are lower in this patient groups. Because there are not enough studies, the investigators aimed to evaluate kinesiophobia and physical activity levels in this patients.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
| |
| healthy controls | 30 healthy controls without pain or additional disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kinesiophobia | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tampa Scale of Kinesiophobia | 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. | 4-8 minutes |
| International Physical Activity Questionnaire Short Form | 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. | 5-10 minutes |
| Beck Depression Inventory | 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. | 10 minutes |
| Fibromyalgia Impact Questionnaire | 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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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
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The patients were recruited from a physical medicine and rehabilitation outpatient clinic of Aksaray University Training and Research Hospital, Aksaray, Turkey. The healthy control group was consisting of doctors, nurses, medical secretaries who work in Aksaray University Training and Research Hospital, and patient care providers that have no pain and additional diseases
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| Name | Affiliation | Role |
|---|---|---|
| Melek A Selçuk | Aksaray University Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aksaray University Training and Research Hospital | Aksaray | Turkey (Türkiye) |
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The patients were recruited from a physical medicine and rehabilitation outpatient clinic of Aksaray University Training and Research Hospital, Aksaray, Turkey. The healthy control group was consisting of doctors, nurses, medical secretaries who work in Aksaray University Training and Research Hospital, and patient care providers that have no pain
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 kinesiophobia: 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. |
| FG001 | 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. kinesiophobia: 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. |
| FG002 | Healthy Controls | 30 healthy controls without pain or additional disease kinesiophobia: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 kinesiophobia: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tampa Scale of Kinesiophobia | 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. | Posted | Mean | Standard Deviation | score on a scale | 4-8 minutes |
|
Adverse Events were not monitored/assessed
Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 kinesiophobia: 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. |
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Small sample size, presence of a difference between the fibromyalgia syndrome and control groups in terms of age and gender, and lack of Neck Pain Disability Index evaluation in the fibromyalgia syndrome group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Aksaray University training and Research Hospital | 905555289493 | mlk.aykut@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Mar 13, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D019547 | Neck Pain |
| D000092442 | Kinesiophobia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D010147 | Pain Measurement |
| D004185 | Disability Evaluation |
| ID | Term |
|---|---|
| D009460 | Neurologic Examination |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 5 minutes |
| Neck Pain Disability Index | 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. | 5-8 minutes |
| Visual Analog Scale for the Evaluation of Pain | 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. | 0.5 minutes |
| Visual Analog Scale for the Evaluation of Fatigue | 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. | 0.5 minutes |
| BG001 | 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. kinesiophobia: 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. |
| BG002 | Healthy Controls | 30 healthy controls without pain or additional disease kinesiophobia: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. kinesiophobia: 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. |
| OG002 | Healthy Controls | 30 healthy controls without pain or additional disease kinesiophobia: 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. |
|
|
| Primary | International Physical Activity Questionnaire Short Form | 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. | Posted | Count of Participants | Participants | 5-10 minutes |
|
|
|
| Primary | Beck Depression Inventory | 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. | Posted | Mean | Standard Deviation | score on a scale | 10 minutes |
|
|
|
| Primary | Fibromyalgia Impact Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale | 5 minutes |
|
|
|
| Primary | Neck Pain Disability Index | 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. | Posted | Mean | Standard Deviation | score on a scale | 5-8 minutes |
|
|
|
| Primary | Visual Analog Scale for the Evaluation of Pain | 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. | Posted | Mean | Standard Deviation | score on a scale | 0.5 minutes |
|
|
|
| Primary | Visual Analog Scale for the Evaluation of Fatigue | 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. | Posted | Mean | Standard Deviation | score on a scale | 0.5 minutes |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. kinesiophobia: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Healthy Controls | 30 healthy controls without pain or additional disease kinesiophobia: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| high |
|