FibromyalgiaNCT07826520
Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
An observational study of Fibromyalgia, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia is a chronic condition that commonly causes widespread pain, fatigue, and difficulty in daily activities. These symptoms may change from day to day, even when their average severity is similar. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults aged 18-65 years who attend the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital and meet the 2016 American College of Rheumatology criteria for fibromyalgia. Both female and male participants will be included. All participants must be able to complete the seven-day symptom records and provide written informed consent. No healthy control group will be included.
Who may be able to join
- Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
- Age between 18 and 65 years
- Ability to understand and complete the daily symptom records
- Ability and willingness to provide written informed consent
Who cannot join
- Active inflammatory rheumatic disease
- Major neurological disease
- Major change in fibromyalgia treatment within the previous three months
- Pregnancy, postpartum period, or breastfeeding
- Cognitive impairment or inability to provide informed consent
- Completion of less than 70% of the required daily symptom records
- Major change in fibromyalgia treatment during the seven-day monitoring period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mardin Training and Research Hospital
Mardin, 47100
Taha Yasin Yıldırım, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Relationship Between Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
Fibromyalgia is a chronic condition that commonly causes widespread pain, fatigue, and difficulty in daily activities. These symptoms may change from day to day, even when their average severity is similar.
This study aims to examine whether daily changes in pain and fatigue are related to functional impact in adults with fibromyalgia. Participants will complete clinical questionnaires at the first visit and record their pain and fatigue levels for seven days. Sleep quality and perceived control over symptoms will also be recorded. No treatment or additional medical procedure will be given as part of the study.
Read the detailed description
Fibromyalgia symptoms do not always remain at the same level. Pain and fatigue may increase or decrease between days and may also change between morning and evening. Clinical assessments usually focus on the average severity of these symptoms. However, patients with similar average pain or fatigue levels may have different levels of difficulty in daily life. This study will therefore examine whether symptom fluctuation provides additional information about functional impact beyond average symptom severity.
Adults diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria will be included. At the initial visit, demographic and clinical information will be recorded. Functional impact will be assessed using the Fibromyalgia Impact Questionnaire. Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale, and symptoms related to central sensitization will be assessed using the Central Sensitization Inventory.
After the initial visit, participants will record pain and fatigue levels every morning and evening for seven days using 0-10 numerical rating scales. They will also record their sleep quality each morning and their perceived control over symptoms once daily. These records will be used to calculate average pain and fatigue levels, daily fluctuations in these symptoms, maximum symptom levels, and the degree to which pain and fatigue change together within each participant.
The main analysis will examine the relationship between pain and fatigue fluctuations and functional impact. It will also evaluate whether symptom fluctuation is related to functional impact after considering average pain and fatigue levels, age, sex, and disease duration. Additional analyses will examine the relationships of pain-fatigue synchrony, sleep quality, maximum symptom levels, and perceived symptom control with functional impact. The study is observational and is not designed to determine cause-and-effect relationships.
- Conditions
- Fibromyalgia
- Keywords
- Symptom Fluctuation, Fibromyalgia Impact Questionnaire, Central Sensitization, Sleep Quality, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Fibromyalgia | Adults aged 18-65 years who meet the 2016 American College of Rheumatology criteria for fibromyalgia will be included. Participants will complete clinical questionnaires at the initial visit and record pain and fatigue levels for seven days. Sleep quality and perceived symptom control will also be recorded. No treatment or experimental intervention will be administered as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
Functional impact will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia. The main analysis will examine whether within-person variability in pain and fatigue over seven days is associated with the FIQ score independently of average pain and fatigue levels.
Measured: At the initial visit
Secondary outcomes (4)
Within-Person Association Between Pain and Fatigue
Participants will rate pain and fatigue every morning and evening for seven days using 0-10 numerical rating scales. The within-person correlation between paired pain and fatigue ratings will be calculated for each participant. The relationship between this correlation and the FIQ total score will be examined.
Measured: During the 7-day monitoring period
Maximum Pain and Fatigue Levels
The highest pain rating and the highest fatigue rating reported by each participant during the seven-day monitoring period will be identified separately. Both are measured on scales from 0 to 10, with higher scores indicating greater symptom severity. Their relationships with the FIQ total score will be examined.
Measured: During the 7-day monitoring period
Perceived Symptom Control
Participants will rate their perceived control over their symptoms once daily for seven days using a scale from 0 to 10. The relationship between perceived symptom control and the FIQ total score will be examined.
Measured: During the 7-day monitoring period
Sleep Quality
Participants will rate the quality of the previous night's sleep each morning for seven days using a scale from 0 to 10. The relationships of sleep quality with pain, fatigue, and the FIQ total score will be examined.
Measured: During the 7-day monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Aug 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gözde Sümer, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826520
- Sponsor's protocol ID
- MTRH-PMR-TYY3
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartley EJ, Robinson ME, Staud R. Pain and Fatigue Variability Patterns Distinguish Subgroups of Fibromyalgia Patients. J Pain. 2018 Apr;19(4):372-381. doi: 10.1016/j.jpain.2017.11.014. Epub 2017 Dec 15.
PubMed 29253551Affleck G, Urrows S, Tennen H, Higgins P, Abeles M. Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia. Pain. 1996 Dec;68(2-3):363-8. doi: 10.1016/s0304-3959(96)03226-5.
PubMed 9121825Harris RE, Williams DA, McLean SA, Sen A, Hufford M, Gendreau RM, Gracely RH, Clauw DJ. Characterization and consequences of pain variability in individuals with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3670-4. doi: 10.1002/art.21407.
PubMed 16258905
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Daily Symptom Fluctuations and Functional Impact in Fibromyalgia
- ClinicalTrials.gov ID
- NCT07826520
- Acronym / sponsor ID
- MTRH-PMR-TYY3
- Conditions
- Fibromyalgia
- Keywords
- Symptom Fluctuation, Fibromyalgia Impact Questionnaire, Central Sensitization, Sleep Quality, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 17 Sep 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 condition that commonly causes widespread pain, fatigue, and difficulty in daily activities. These symptoms may change from day to day, even when their average severity is similar.
This study aims to examine whether daily changes in pain and fatigue are related to functional impact in adults with fibromyalgia. Participants will complete clinical questionnaires at the first visit and record their pain and fatigue levels for seven days. Sleep quality and perceived control over symptoms will also be recorded. No treatment or additional medical procedure will be given as part of the study.
Detailed description
Fibromyalgia symptoms do not always remain at the same level. Pain and fatigue may increase or decrease between days and may also change between morning and evening. Clinical assessments usually focus on the average severity of these symptoms. However, patients with similar average pain or fatigue levels may have different levels of difficulty in daily life. This study will therefore examine whether symptom fluctuation provides additional information about functional impact beyond average symptom severity.
Adults diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria will be included. At the initial visit, demographic and clinical information will be recorded. Functional impact will be assessed using the Fibromyalgia Impact Questionnaire. Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale, and symptoms related to central sensitization will be assessed using the Central Sensitization Inventory.
After the initial visit, participants will record pain and fatigue levels every morning and evening for seven days using 0-10 numerical rating scales. They will also record their sleep quality each morning and their perceived control over symptoms once daily. These records will be used to calculate average pain and fatigue levels, daily fluctuations in these symptoms, maximum symptom levels, and the degree to which pain and fatigue change together within each participant.
The main analysis will examine the relationship between pain and fatigue fluctuations and functional impact. It will also evaluate whether symptom fluctuation is related to functional impact after considering average pain and fatigue levels, age, sex, and disease duration. Additional analyses will examine the relationships of pain-fatigue synchrony, sleep quality, maximum symptom levels, and perceived symptom control with functional impact. The study is observational and is not designed to determine cause-and-effect relationships.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Fibromyalgia | – | –Adults aged 18-65 years who meet the 2016 American College of Rheumatology criteria for fibromyalgia will be included. Participants will complete clinical questionnaires at the initial visit and record pain and fatigue levels for seven days. Sleep quality and perceived symptom control will also be recorded. No treatment or experimental intervention will be administered as part of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18-65 years who attend the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital and meet the 2016 American College of Rheumatology criteria for fibromyalgia. Both female and male participants will be included. All participants must be able to complete the seven-day symptom records and provide written informed consent. No healthy control group will be included.
Key inclusion criteria (4 listed)
- Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
- Age between 18 and 65 years
- Ability to understand and complete the daily symptom records
- Ability and willingness to provide written informed consent
Key exclusion criteria (7 listed)
- Active inflammatory rheumatic disease
- Major neurological disease
- Major change in fibromyalgia treatment within the previous three months
- Pregnancy, postpartum period, or breastfeeding
- Cognitive impairment or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Impact Assessed by the Fibromyalgia Impact Questionnaire
Time frame: At the initial visit
Functional impact will be assessed using the Fibromyalgia Impact Questionnaire (FIQ). The total score ranges from 0 to 100, with higher scores indicating greater impact of fibromyalgia. The main analysis will examine whether within-person variability in pain and fatigue over seven days is associated with the FIQ score independently of average pain and fatigue levels.
4 secondary outcomes
Within-Person Association Between Pain and Fatigue
Time frame: During the 7-day monitoring period
Maximum Pain and Fatigue Levels
Time frame: During the 7-day monitoring period
Perceived Symptom Control
Time frame: During the 7-day monitoring period
Sleep Quality
Time frame: During the 7-day monitoring period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 29253551Bartley EJ, Robinson ME, Staud R. Pain and Fatigue Variability Patterns Distinguish Subgroups of Fibromyalgia Patients. J Pain. 2018 Apr;19(4):372-381. doi: 10.1016/j.jpain.2017.11.014. Epub 2017 Dec 15.
- Background: PubMed 9121825Affleck G, Urrows S, Tennen H, Higgins P, Abeles M. Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia. Pain. 1996 Dec;68(2-3):363-8. doi: 10.1016/s0304-3959(96)03226-5.
- Background: PubMed 16258905Harris RE, Williams DA, McLean SA, Sen A, Hufford M, Gendreau RM, Gracely RH, Clauw DJ. Characterization and consequences of pain variability in individuals with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3670-4. doi: 10.1002/art.21407.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Mardin Artuklu 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 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Yasin YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Impact Assessed by the Fibromyalgia Impact Questionnaire (time frame: At the initial visit). 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 NCT07826520, which also lists 3 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 17 Sep 2026.