FibromyalgiaNCT07318441
Functional Capacity Determinants in Fibromyalgia
A study testing Assessment Only in people with Fibromyalgia and Fatigue, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia is a chronic pain disorder characterized by widespread pain and multiple systemic symptoms that negatively affect functional capacity. Although common symptoms and clinical features of fibromyalgia have been well described, the factors influencing functional capacity remain unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia, Fatigue
- What is being tested?
- Assessment Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with fibromyalgia according to the American College of Rheumatology criteria
- Be 18 years of age or older
- Be a volunteer
- Be able to read and write
Who cannot join
- Having a condition that prevents communication,
- Having undergone surgery within the last 6 months
- Being an elite athlete
- Having an active infection
- Having a neurological or orthopedic problem that prevents movement
- Being a cancer patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Functional Capacity in Patients With Fibromyalgia
Fibromyalgia is a chronic pain disorder characterized by widespread pain and multiple systemic symptoms that negatively affect functional capacity. Although common symptoms and clinical features of fibromyalgia have been well described, the factors influencing functional capacity remain unclear. Therefore, this study aims to identify the determinants of functional capacity in patients with fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic pain disorder characterized by widespread pain, fatigue, sleep disturbances, cognitive problems, and mood disorders, affecting 5% of the population, predominantly women. This condition lacks objective diagnostic markers and relies on subjective symptoms and tender points for diagnosis. The etiology of fibromyalgia, which involves biological, genetic, and environmental factors, remains unclear, making diagnosis difficult due to symptom variability and comorbidities. Pathophysiological mechanisms are not fully understood, leading to difficulties in diagnosis and treatment. Historically, fibromyalgia has evolved from terms such as 'neurasthenia' to 'fibrositis', and understanding has shifted from muscle inflammation to central nervous system dysfunction. The American College of Rheumatology criteria play a crucial role in diagnosing fibromyalgia, helping to reduce patient anxiety and unnecessary testing. In the literature, pain, fatigue, sleep problems, and trigger point sensitivity are among the symptoms frequently seen in fibromyalgia patients. Studies conducted on these symptoms indicate that patients particularly experience anxiety, depression, decreased functional capacity, decreased functional mobility, postural abnormalities, decreased respiratory and peripheral muscle strength, decreased physical activity, and difficulties in daily living activities.
Although surveys conducted with fibromyalgia patients have identified symptoms, no studies have been found that examine the factors affecting functional capacity. Therefore, the aim of this study is to determine the factors affecting functional capacity in patients with fibromyalgia.
- Conditions
- Fibromyalgia, Fatigue
- Being tested
- Assessment Only
- Keywords
- fibromyalgia, functional capacity, fatigue
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment OnlyOther
No therapeutic intervention will be applied. Participants will undergo standardized clinical, functional, and self-reported assessments, including functional capacity tests, pain and fatigue evaluation, mobility and muscle strength assessments, posture analysis, psychosocial questionnaires, physical activity level, circadian rhythm, and sleep quality evaluation
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Group | Other | Patients diagnosed with fibromyalgia who attend the Physical Medicine and Rehabilitation Outpatient Clinic will undergo comprehensive assessments of functional capacity, pain, fatigue, mobility, muscle strength, posture, psychosocial factors, physical activity level, circadian rhythm, and sleep quality. No intervention will be applied. Receives: Other: Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (for Pain and Fatigue)
Pain intensity and fatigue intensity will be assessed using the visual analog scale (VAS). It is frequently preferred because it is an easy and understandable scale. Participants are asked to mark the appropriate place on a 10 cm horizontal line, where the beginning indicates no pain and the end indicates unbearable pain. The same scale will be used to assess fatigue intensity. The beginning of the line indicates no fatigue, and the end indicates extreme fatigue. To measure the intensity, the distance from the beginning of the line to the point marked by the participant will be measured with a ruler and recorded
Measured: baseline
6-Minute Walk Test
The 6-minute walk test is a reliable test for fibromyalgia patients and has been used as an indicator of cardiorespiratory fitness in patients with fibromyalgia. It is frequently used in the assessment of functional capacity. It is simple, practical, and inexpensive. It does not require special equipment or advanced training and is well tolerated by patients. The patient is asked to walk as fast as they can without running in a corridor of at least 30 meters. The distance covered in 6 minutes is measured.
Measured: baseline
Timed Up and Go Test
It is a reliable test frequently used to assess agility, dynamic balance, and functional mobility in individuals with fibromyalgia. The Timed Up and Go test was developed by Podsiadlo and Richardson (1991). Participants will begin the test by sitting in a chair with back support. They will stand up from the chair, walk to a mark 3 meters away, and return to sit down, at which point the time will be recorded .
Measured: baseline
30-second sit-to-stand test
Used to measure lower body muscle strength. Participants begin the test by sitting on a chair with their arms crossed at chest level and their hands on their shoulders. From this sitting position, they must stand up until their knees are fully extended and then sit back down until their backs touch the back of the chair. The number of repetitions within 30 seconds is recorded. It is a reliable test for individuals with fibromyalgia
Measured: baseline
Hand Grip Strength
Grip strength is considered an indicator of upper extremity muscle strength. Measurements will be recorded by testing the dominant and non-dominant hand three times using the JAMAR hand dynamometer. This device is a widely used and highly reliable grip strength measurement tool. The test will be performed in a sitting position, with the upper arm parallel to the body, the elbow flexed at 90 degrees, and the forearm and hand in a neutral position.
Measured: baseline
Assessment of Tender Points
In our study, an algometer device will be used to assess tender points. The algometer device is a reliable device that can be used to assess tender points. Eighteen tender points will be assessed according to the American College of Rheumatology criteria for the classification of fibromyalgia. They will be marked with a pen before use. The tender points to be marked are: occipital, lower cervical, trapezius, supraspinatus, second rib, lateral epicondyle, gluteal, greater trochanter, and knees. Pain assessment will be performed by applying a vertical pressure of approximately 1 kg/s to the tender points with the algometer, and the person will be asked to report when the pressure becomes painful. A high algometer score indicates low pain
Measured: baseline
New York Posture Assessment
The New York Posture Assessment is a valid and reliable assessment used in posture evaluation. Posture is assessed from the lateral and posterior views. It includes a series of three-digit drawings for each of the 13 body alignment sections. These are scored as 5 (correct posture), 3 (mild deviation), or 1 (significant deviation). The highest score is 65, and the lowest is 13. A score ≥45 is "excellent," 40-44 is "good," 30-39 is "moderate," 20-29 is "poor," and ≤19 is "very poor"
Measured: baseline
Revised Fibromyalgia Impact Questionnaire
A study by Ediz and colleagues demonstrated that the Turkish version of the Revised Fibromyalgia Impact Questionnaire is a reliable and valid tool. It is a self-reported questionnaire that measures functional capacity and disease severity in patients with fibromyalgia. It is an easy and short questionnaire. It consists of 3 sections with 21 questions on function, overall impact, and symptoms. It concerns experiences in the last 7 days and is scored using an 11-point numerical rating scale. The total score for the function domain (range 0 to 90, divided by 3), the global impact domain score (range 0 to 20), and the symptoms domain score (range 0 to 100, divided by 2)
Measured: baseline
Multidimensional Fatigue Inventory
Smets et al. developed the Multidimensional Fatigue Inventory-20 (MFI-20), which consists of five fatigue subscales: general fatigue, physical fatigue, mental fatigue, decreased motivation, and decreased activity. It has been used in various descriptive and experimental studies of many different diseases, including fibromyalgia. Özilhan et al.'s study demonstrated that the Turkish oncology version of the MFI-20 is a valid and reliable measure of fatigue in cancer patients, while Başoğlu et al.'s study demonstrated that it is a valid and reliable measure of fatigue in patients with multidimensional FM. When completing the scale, individuals are asked to select the degree closest to themselves, ranging from "no, not true" to "yes, very true." It consists of 20 questions. A high score indicates severe fatigue.
Measured: baseline
Fibromyalgia Participation Questionnaire
This is a scale that evaluates patients' social participation, daily life, and work life over the past four weeks. The questionnaire consists of 27 items. The first 16 items relate to daily life, and the following 6 items focus on the patients' social lives. Item 23 asks patients whether they are currently employed, and they can answer with "yes" or "no". Patients who answer "yes" are then asked about the level of difficulty they experience in their work life on five separate items. Patients are allowed to rate these levels on a scale of 1 to 5. The total score is calculated as the sum of the first 22 items for patients who are not employed, and as the sum of all 27 items for patients who are employed. The minimum score for those who are not employed is 22, and the maximum score is 110; for those who are employed, the minimum score is 27, and the maximum score is 135. A higher score indicates a more severe impairment (restriction).
Measured: baseline
Pain Catastrophizing Scale
This is a self-administered questionnaire used to assess the patient's feelings and thoughts about pain. It was developed by Sullivan and colleagues in 1995. It is a reliable and valid Turkish-language questionnaire that assesses specific variables such as severe pain, disability, and emotional distress following trauma or tissue damage. It consists of the subscales "helplessness" (inability to cope effectively with pain), 'magnification' (dissatisfaction caused by excessive focus on the negative consequences of pain), and "rumination" (inability to stop thinking about pain). It consists of 13 items and is scored on a scale of 0 to 4. It is a 52-point scale.
Measured: baseline
Kinesiophobia Assessment
Participants in our study will be assessed for kinesiophobia, or fear of movement/re-injury, using the Tampa Kinesiophobia Scale, whose test-retest reliability in Turkish has been demonstrated by Tunca Yılmaz and colleagues. The scale was first developed in 1991 but was not published. It was published by Vlaeyen and colleagues in 1995. The scale covers work-related activities, injury/re-injury, and fear-avoidance. It consists of 17 questions. It is scored as follows: Strongly disagree 1, Disagree 2, Agree 3, Strongly agree 4. It is scored between 17 and 68. The higher the score, the higher the fear of movement.
Measured: baseline
Hospital Anxiety and Depression Scale
It consists of 14 questions in total, 7 of which assess anxiety, 7 assess depression, and the odd-numbered questions assess anxiety symptoms while the even-numbered questions assess depression symptoms. Each question is scored between 0 and 3. Higher scores indicate higher levels of anxiety and depression.
Measured: baseline
Circadian Rhythm Assessment
The Morningness-Eveningness Questionnaire was developed by Horne and Ostberg in 1976 to behaviorally assess individuals' circadian rhythms and interpersonal biological rhythm variations [39]. It is the most commonly used measure for assessing chronotype preference.It consists of 19 self-assessment items, and scores are calculated according to five chronotype categories. A high score indicates a strong morning preference.
Measured: baseline
International Physical Activity Questionnaire Short Form (IPAQ)
It is a commonly used measure for assessing physical activity. In our study, the 7-item International Physical Activity Questionnaire Short Form will be used.The number of days and duration of vigorous physical activity, moderate physical activity, and walking activities lasting at least 10 minutes or longer in the past 7 days are assessed. The number of days and minutes are calculated by multiplying each activity's MET value. Vigorous physical activities are calculated as 8 MET, moderate physical activities as 4 MET, and walking as 3.3 MET. Time spent sitting is not included in the scoring. All are added together for the overall physical activity score. A weekly MET value below 600 is considered inactive, 601-3,000 is moderately active, and above 3,000 is active.
Measured: baseline
Pittsburgh Sleep Quality Index
This is a questionnaire consisting of 24 questions that assesses individuals' sleep quality and sleep disorders.The first 19 questions are answered by the individual themselves, while the last 5 questions are to be answered by their spouse or roommate. The last 5 questions are not included when calculating the total score. A high score indicates poor sleep quality. The first 19 questions assess a wide range of factors to estimate sleep duration, sleep onset latency, and the frequency and severity of sleep-related problems. It consists of a total of 7 subheadings: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medications, and daytime dysfunction. Each subheading is scored from 0 to 3 and has its own calculation method. The total score ranges from 0 to 21. A score of 5 or above indicates poor sleep quality .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Sep 2024
- Primary completion15 Feb 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals diagnosed with fibromyalgia according to the American College of Rheumatology criteria
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Beyzanur Beğenen Şavlı, Msc.Pt., Principal investigator, Izmir Democracy UniversityBetül Taspinar, Prof.Dr., Principal investigator, Izmir Democracy UniversityFerruh Taspinar, Prof.Dr., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318441
- Sponsor's protocol ID
- FMS-35
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Functional Capacity in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07318441
- Acronym / sponsor ID
- FMS-35
- Conditions
- Fibromyalgia, Fatigue
- Keywords
- fibromyalgia, functional capacity, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia is a chronic pain disorder characterized by widespread pain and multiple systemic symptoms that negatively affect functional capacity. Although common symptoms and clinical features of fibromyalgia have been well described, the factors influencing functional capacity remain unclear. Therefore, this study aims to identify the determinants of functional capacity in patients with fibromyalgia.
Detailed description
Fibromyalgia is a chronic pain disorder characterized by widespread pain, fatigue, sleep disturbances, cognitive problems, and mood disorders, affecting 5% of the population, predominantly women. This condition lacks objective diagnostic markers and relies on subjective symptoms and tender points for diagnosis. The etiology of fibromyalgia, which involves biological, genetic, and environmental factors, remains unclear, making diagnosis difficult due to symptom variability and comorbidities. Pathophysiological mechanisms are not fully understood, leading to difficulties in diagnosis and treatment. Historically, fibromyalgia has evolved from terms such as 'neurasthenia' to 'fibrositis', and understanding has shifted from muscle inflammation to central nervous system dysfunction. The American College of Rheumatology criteria play a crucial role in diagnosing fibromyalgia, helping to reduce patient anxiety and unnecessary testing. In the literature, pain, fatigue, sleep problems, and trigger point sensitivity are among the symptoms frequently seen in fibromyalgia patients. Studies conducted on these symptoms indicate that patients particularly experience anxiety, depression, decreased functional capacity, decreased functional mobility, postural abnormalities, decreased respiratory and peripheral muscle strength, decreased physical activity, and difficulties in daily living activities.
Although surveys conducted with fibromyalgia patients have identified symptoms, no studies have been found that examine the factors affecting functional capacity. Therefore, the aim of this study is to determine the factors affecting functional capacity in patients with fibromyalgia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals diagnosed with fibromyalgia according to the American College of Rheumatology criteria
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Group | Other | Other: Assessment OnlyPatients diagnosed with fibromyalgia who attend the Physical Medicine and Rehabilitation Outpatient Clinic will undergo comprehensive assessments of functional capacity, pain, fatigue, mobility, muscle strength, posture, psychosocial factors, physical activity level, circadian rhythm, and sleep quality. No intervention will be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals diagnosed with fibromyalgia according to the American College of Rheumatology criteria
- Be 18 years of age or older
- Be a volunteer
- Be able to read and write
Key exclusion criteria (6 listed)
- Having a condition that prevents communication,
- Having undergone surgery within the last 6 months
- Being an elite athlete
- Having an active infection
- Having a neurological or orthopedic problem that prevents movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment OnlyNo therapeutic intervention will be applied. Participants will undergo standardized clinical, functional, and self-reported assessments, including functional capacity tests, pain and fatigue evaluation, mobility and muscle strength assessments, posture analysis, psychosocial questionnaires, physical activity level, circadian rhythm, and sleep quality evaluation | Other | Fibromyalgia Group |
Primary outcome
Visual Analog Scale (for Pain and Fatigue)
Time frame: baseline
Pain intensity and fatigue intensity will be assessed using the visual analog scale (VAS). It is frequently preferred because it is an easy and understandable scale. Participants are asked to mark the appropriate place on a 10 cm horizontal line, where the beginning indicates no pain and the end indicates unbearable pain. The same scale will be used to assess fatigue intensity. The beginning of the line indicates no fatigue, and the end indicates extreme fatigue. To measure the intensity, the distance from the beginning of the line to the point marked by the participant will be measured with a ruler and recorded
6-Minute Walk Test
Time frame: baseline
The 6-minute walk test is a reliable test for fibromyalgia patients and has been used as an indicator of cardiorespiratory fitness in patients with fibromyalgia. It is frequently used in the assessment of functional capacity. It is simple, practical, and inexpensive. It does not require special equipment or advanced training and is well tolerated by patients. The patient is asked to walk as fast as they can without running in a corridor of at least 30 meters. The distance covered in 6 minutes is measured.
Timed Up and Go Test
Time frame: baseline
It is a reliable test frequently used to assess agility, dynamic balance, and functional mobility in individuals with fibromyalgia. The Timed Up and Go test was developed by Podsiadlo and Richardson (1991). Participants will begin the test by sitting in a chair with back support. They will stand up from the chair, walk to a mark 3 meters away, and return to sit down, at which point the time will be recorded .
30-second sit-to-stand test
Time frame: baseline
Used to measure lower body muscle strength. Participants begin the test by sitting on a chair with their arms crossed at chest level and their hands on their shoulders. From this sitting position, they must stand up until their knees are fully extended and then sit back down until their backs touch the back of the chair. The number of repetitions within 30 seconds is recorded. It is a reliable test for individuals with fibromyalgia
Hand Grip Strength
Time frame: baseline
Grip strength is considered an indicator of upper extremity muscle strength. Measurements will be recorded by testing the dominant and non-dominant hand three times using the JAMAR hand dynamometer. This device is a widely used and highly reliable grip strength measurement tool. The test will be performed in a sitting position, with the upper arm parallel to the body, the elbow flexed at 90 degrees, and the forearm and hand in a neutral position.
Assessment of Tender Points
Time frame: baseline
In our study, an algometer device will be used to assess tender points. The algometer device is a reliable device that can be used to assess tender points. Eighteen tender points will be assessed according to the American College of Rheumatology criteria for the classification of fibromyalgia. They will be marked with a pen before use. The tender points to be marked are: occipital, lower cervical, trapezius, supraspinatus, second rib, lateral epicondyle, gluteal, greater trochanter, and knees. Pain assessment will be performed by applying a vertical pressure of approximately 1 kg/s to the tender points with the algometer, and the person will be asked to report when the pressure becomes painful. A high algometer score indicates low pain
New York Posture Assessment
Time frame: baseline
The New York Posture Assessment is a valid and reliable assessment used in posture evaluation. Posture is assessed from the lateral and posterior views. It includes a series of three-digit drawings for each of the 13 body alignment sections. These are scored as 5 (correct posture), 3 (mild deviation), or 1 (significant deviation). The highest score is 65, and the lowest is 13. A score ≥45 is "excellent," 40-44 is "good," 30-39 is "moderate," 20-29 is "poor," and ≤19 is "very poor"
Revised Fibromyalgia Impact Questionnaire
Time frame: baseline
A study by Ediz and colleagues demonstrated that the Turkish version of the Revised Fibromyalgia Impact Questionnaire is a reliable and valid tool. It is a self-reported questionnaire that measures functional capacity and disease severity in patients with fibromyalgia. It is an easy and short questionnaire. It consists of 3 sections with 21 questions on function, overall impact, and symptoms. It concerns experiences in the last 7 days and is scored using an 11-point numerical rating scale. The total score for the function domain (range 0 to 90, divided by 3), the global impact domain score (range 0 to 20), and the symptoms domain score (range 0 to 100, divided by 2)
Multidimensional Fatigue Inventory
Time frame: baseline
Smets et al. developed the Multidimensional Fatigue Inventory-20 (MFI-20), which consists of five fatigue subscales: general fatigue, physical fatigue, mental fatigue, decreased motivation, and decreased activity. It has been used in various descriptive and experimental studies of many different diseases, including fibromyalgia. Özilhan et al.'s study demonstrated that the Turkish oncology version of the MFI-20 is a valid and reliable measure of fatigue in cancer patients, while Başoğlu et al.'s study demonstrated that it is a valid and reliable measure of fatigue in patients with multidimensional FM. When completing the scale, individuals are asked to select the degree closest to themselves, ranging from "no, not true" to "yes, very true." It consists of 20 questions. A high score indicates severe fatigue.
Fibromyalgia Participation Questionnaire
Time frame: baseline
This is a scale that evaluates patients' social participation, daily life, and work life over the past four weeks. The questionnaire consists of 27 items. The first 16 items relate to daily life, and the following 6 items focus on the patients' social lives. Item 23 asks patients whether they are currently employed, and they can answer with "yes" or "no". Patients who answer "yes" are then asked about the level of difficulty they experience in their work life on five separate items. Patients are allowed to rate these levels on a scale of 1 to 5. The total score is calculated as the sum of the first 22 items for patients who are not employed, and as the sum of all 27 items for patients who are employed. The minimum score for those who are not employed is 22, and the maximum score is 110; for those who are employed, the minimum score is 27, and the maximum score is 135. A higher score indicates a more severe impairment (restriction).
Pain Catastrophizing Scale
Time frame: baseline
This is a self-administered questionnaire used to assess the patient's feelings and thoughts about pain. It was developed by Sullivan and colleagues in 1995. It is a reliable and valid Turkish-language questionnaire that assesses specific variables such as severe pain, disability, and emotional distress following trauma or tissue damage. It consists of the subscales "helplessness" (inability to cope effectively with pain), 'magnification' (dissatisfaction caused by excessive focus on the negative consequences of pain), and "rumination" (inability to stop thinking about pain). It consists of 13 items and is scored on a scale of 0 to 4. It is a 52-point scale.
Kinesiophobia Assessment
Time frame: baseline
Participants in our study will be assessed for kinesiophobia, or fear of movement/re-injury, using the Tampa Kinesiophobia Scale, whose test-retest reliability in Turkish has been demonstrated by Tunca Yılmaz and colleagues. The scale was first developed in 1991 but was not published. It was published by Vlaeyen and colleagues in 1995. The scale covers work-related activities, injury/re-injury, and fear-avoidance. It consists of 17 questions. It is scored as follows: Strongly disagree 1, Disagree 2, Agree 3, Strongly agree 4. It is scored between 17 and 68. The higher the score, the higher the fear of movement.
Hospital Anxiety and Depression Scale
Time frame: baseline
It consists of 14 questions in total, 7 of which assess anxiety, 7 assess depression, and the odd-numbered questions assess anxiety symptoms while the even-numbered questions assess depression symptoms. Each question is scored between 0 and 3. Higher scores indicate higher levels of anxiety and depression.
Circadian Rhythm Assessment
Time frame: baseline
The Morningness-Eveningness Questionnaire was developed by Horne and Ostberg in 1976 to behaviorally assess individuals' circadian rhythms and interpersonal biological rhythm variations [39]. It is the most commonly used measure for assessing chronotype preference.It consists of 19 self-assessment items, and scores are calculated according to five chronotype categories. A high score indicates a strong morning preference.
International Physical Activity Questionnaire Short Form (IPAQ)
Time frame: baseline
It is a commonly used measure for assessing physical activity. In our study, the 7-item International Physical Activity Questionnaire Short Form will be used.The number of days and duration of vigorous physical activity, moderate physical activity, and walking activities lasting at least 10 minutes or longer in the past 7 days are assessed. The number of days and minutes are calculated by multiplying each activity's MET value. Vigorous physical activities are calculated as 8 MET, moderate physical activities as 4 MET, and walking as 3.3 MET. Time spent sitting is not included in the scoring. All are added together for the overall physical activity score. A weekly MET value below 600 is considered inactive, 601-3,000 is moderately active, and above 3,000 is active.
Pittsburgh Sleep Quality Index
Time frame: baseline
This is a questionnaire consisting of 24 questions that assesses individuals' sleep quality and sleep disorders.The first 19 questions are answered by the individual themselves, while the last 5 questions are to be answered by their spouse or roommate. The last 5 questions are not included when calculating the total score. A high score indicates poor sleep quality. The first 19 questions assess a wide range of factors to estimate sleep duration, sleep onset latency, and the frequency and severity of sleep-related problems. It consists of a total of 7 subheadings: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medications, and daytime dysfunction. Each subheading is scored from 0 to 3 and has its own calculation method. The total score ranges from 0 to 21. A score of 5 or above indicates poor sleep quality .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beyzanur Beğenen Şavlı, Msc.Pt. principal investigator
Izmir Democracy University
Betül Taspinar, Prof.Dr. principal investigator
Izmir Democracy University
Ferruh Taspinar, Prof.Dr. principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment Only in people with Fibromyalgia and Fatigue, run by Izmir Democracy University 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 4 inclusion and 6 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 8 Jan 2026. 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?
Visual Analog Scale (for Pain and Fatigue) (time frame: baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.