Fibromyalgia, Healthy, Neck Pain
Conditions
Keywords
kinesiophobia, physical activity, disability
Brief summary
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.
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).
Interventions
DIAGNOSTIC_TESTkinesiophobia
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.
Sponsors
Aksaray University Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale of Kinesiophobia | 4-8 minutes | 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. |
| International Physical Activity Questionnaire Short Form | 5-10 minutes | 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. |
| Beck Depression Inventory | 10 minutes | 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. |
| Fibromyalgia Impact Questionnaire | 5 minutes | 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. |
| Neck Pain Disability Index | 5-8 minutes | 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. |
| Visual Analog Scale for the Evaluation of Pain | 0.5 minutes | 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. |
| Visual Analog Scale for the Evaluation of Fatigue | 0.5 minutes | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| 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. | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Chronic Neck Pain | Healthy Controls | Fibromyalgia Syndrome | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Continuous | 38.50 years STANDARD_DEVIATION 11.65 | 35.40 years STANDARD_DEVIATION 9.95 | 42.96 years STANDARD_DEVIATION 10.88 | 38.91 years STANDARD_DEVIATION 11.15 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Turkey | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 28 Participants | 77 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 2 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Beck Depression Inventory | 18.37 score on a scale | Standard Deviation 8.07 |
| Chronic Neck Pain | Beck Depression Inventory | 12.03 score on a scale | Standard Deviation 7.09 |
| Healthy Controls | Beck Depression Inventory | 5.44 score on a scale | Standard Deviation 5.68 |
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.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Fibromyalgia Impact Questionnaire | 49.79 score on a scale | Standard Deviation 22.6 |
| Chronic Neck Pain | Fibromyalgia Impact Questionnaire | 44.44 score on a scale | Standard Deviation 15.71 |
| Healthy Controls | Fibromyalgia Impact Questionnaire | 13.79 score on a scale | Standard Deviation 10.17 |
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.
Time frame: 5-10 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fibromyalgia Syndrome | International Physical Activity Questionnaire Short Form | high | 2 Participants |
| Fibromyalgia Syndrome | International Physical Activity Questionnaire Short Form | moderate | 7 Participants |
| Fibromyalgia Syndrome | International Physical Activity Questionnaire Short Form | low | 21 Participants |
| Chronic Neck Pain | International Physical Activity Questionnaire Short Form | moderate | 11 Participants |
| Chronic Neck Pain | International Physical Activity Questionnaire Short Form | low | 14 Participants |
| Chronic Neck Pain | International Physical Activity Questionnaire Short Form | high | 5 Participants |
| Healthy Controls | International Physical Activity Questionnaire Short Form | low | 7 Participants |
| Healthy Controls | International Physical Activity Questionnaire Short Form | high | 7 Participants |
| Healthy Controls | International Physical Activity Questionnaire Short Form | moderate | 16 Participants |
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.
Time frame: 5-8 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Neck Pain Disability Index | 49.06 score on a scale | Standard Deviation 21.65 |
| Chronic Neck Pain | Neck Pain Disability Index | 6.16 score on a scale | Standard Deviation 10.21 |
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.
Time frame: 4-8 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Tampa Scale of Kinesiophobia | 41.70 score on a scale | Standard Deviation 6.3 |
| Chronic Neck Pain | Tampa Scale of Kinesiophobia | 38.33 score on a scale | Standard Deviation 7.98 |
| Healthy Controls | Tampa Scale of Kinesiophobia | 30.83 score on a scale | Standard Deviation 8.84 |
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.
Time frame: 0.5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Visual Analog Scale for the Evaluation of Fatigue | 74.66 score on a scale | Standard Deviation 28.37 |
| Chronic Neck Pain | Visual Analog Scale for the Evaluation of Fatigue | 64.33 score on a scale | Standard Deviation 24.59 |
| Healthy Controls | Visual Analog Scale for the Evaluation of Fatigue | 41.66 score on a scale | Standard Deviation 23.05 |
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.
Time frame: 0.5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia Syndrome | Visual Analog Scale for the Evaluation of Pain | 75.83 score on a scale | Standard Deviation 27.26 |
| Chronic Neck Pain | Visual Analog Scale for the Evaluation of Pain | 50.33 score on a scale | Standard Deviation 23.85 |
| Healthy Controls | Visual Analog Scale for the Evaluation of Pain | 0 score on a scale | Standard Deviation 0 |