FibromyalgiaNCT06969716
Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Geriatric Parameters
An observational study of Fibromyalgia and Old Age; Debility, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Old Age; Debility
- What is being tested?
- Detailed geriatric assessment
- How many people
- 420 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 3 Mar 2026
- Phase
- Observational
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study
Who may be able to join
- Age 80 and above
- Patients with complete detailed geriatric assessment parameters
Who cannot join
- Presence of neurodegenerative disease (dementia, parkinsonism)
- Immobilized patient
- Those who have had an acute illness (infection, fracture, cerebrovascular disease) in the last month
- Having psychotic disorders
- Having severe hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Detailed Geriatric Assessment Parameters
The aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome.
- Conditions
- Fibromyalgia, Old Age; Debility
- Being tested
- Detailed geriatric assessment
- Medical subject headings
- Fibromyalgia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed geriatric assessmentOther
The demographic characteristics of the patients, comorbid diseases, history and number of falls in the last 6 months will be questioned, and the thyroid stimulating hormone, calciferol, cobalamin, glycosylated hemoglobin, folic acid and glomerular filtration rate levels routinely requested from each patient in the last 3 months will be recorded. During the outpatient clinic application, the patients will undergo neurocognitive assessment, mood assessment, daily living activities assessment, balance and walking assessment, nutritional assessment and frailty assessment. The patients' handgrip strength from their dominant hand will be assessed with a hand dynamometer. The walking speed of the patients will be measured as the number of seconds it takes to walk 4 meters and recorded in seconds. All patients will be questioned about the presence of body pain with the numerical pain scale score and all patients will be evaluated for the presence of fibromyalgia syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Patients | Age 80 and above Receives: Other: Detailed geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of fibromyalgia syndrome
The presence of fibromyalgia will be evaluated using the 2016 American College of Rheumatology diagnostic criteria.
Measured: Baseline
Secondary outcomes (7)
Neurocognitive assessment
Neurocognitive assessment will be done with Mini Mental State Examination (MMSE). MMSE test is a short screening test with 11 questions and 30 points. MMSE is completed in approximately 10 minutes and evaluates orientation, memory, attention, calculation, recall, language, motor function and perception, visual-spatial abilities. 24-30 points is normal, 18-23 points is mild dementia, 17 and below is compatible with severe dementia.
Measured: Baseline
Mood assessment
Mood assessment will be assessed with the Geriatric Depression Scale-short form (GDS-SF). GDS-SF consists of 15 questions that patients answer yes or no. Scoring is done as the number of yes answers, and the total depression score is calculated from the sum of the scores. Scores between 0-9 are considered "normal", scores between 10-19 are considered "mild depression", and scores between 20-30 are considered "severe depression".
Measured: Baseline
Daily living activities
The assessment of daily living activities will be assessed with the Lawton-Brody Instrumental Activities of Daily Living Scale (IADLS). IADLS consists of 8 questions that include information on using the telephone, preparing meals, shopping, doing daily housework, doing laundry, being able to get on a vehicle, being able to use medications, and managing money. 0-8 points are evaluated as "dependent," 9-16 points as "semi-dependent," and 17-24 points as "independent."
Measured: Baseline
Balance and walking assessment
Balance and walking assessment will be assessed with the Tinetti Performance-Oriented Mobility Assessment (POMA). POMA assesses balance ability and walking under 2 main headings. The first 9 questions are about balance, the next 7 questions are about walking. Calculation of the survey score; the total score of the first 9 items gives the balance score, the total score of the next 7 items gives the walking score, and the sum of the balance and walking scores gives the total POMA score. Individuals with a score of 18 and below are considered to have poor balance and walking.
Measured: Baseline
Nutritional assessment
Nutritional assessment will be evaluated with the Mini Nutritional Assessment questionnaire-short form (MNA-SF). MNA-SF consists of 5 subheadings; those with 12-14 points are considered "no risk of malnutrition", those with 8-11 points are considered "at risk of malnutrition" and those with 0-7 points are considered "malnourished".
Measured: Baseline
Frailty
Frailty will be assessed using the Clinical Frailty Scale (CFS). CFS is graded from 1 to 9. The higher the score, the greater the frailty.
Measured: Baseline
Activities of daily living
The assessment of daily living activities will be assessed with the the Barthel Index (BI) scale. BI consists of 10 questions that evaluate feeding, washing, self-care, dressing, defecation control, urinary control, going to the toilet, the ability to get from bed to a wheelchair, mobility status such as walking or being wheelchair dependent, and climbing stairs. 0-20 points are considered as completely dependent, 21-61 points as severely dependent, 62-90 points as moderately dependent, 91-99 points as slightly dependent, and 100 points as completely independent.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 May 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
- Investigators
- Kübra Altunkalem Seydi, MD, Principal investigator, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969716
- Sponsor's protocol ID
- 27/3/2025-Number:03/29
- Status last verified
- Mar 2026
- First submitted
- 3 May 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, the data of the study will be shared by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Detailed Geriatric Assessment Parameters
- ClinicalTrials.gov ID
- NCT06969716
- Acronym / sponsor ID
- 27/3/2025-Number:03/29
- Conditions
- Fibromyalgia, Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 14 May 2025 (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.
The aim of this study was to determine the prevalence of fibromyalgia syndrome in patients aged 80 years and over and to examine the relationship between detailed geriatric assessment parameters and fibromyalgia syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Patients | – | Other: Detailed geriatric assessmentAge 80 and above |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study
Key inclusion criteria (2 listed)
- Age 80 and above
- Patients with complete detailed geriatric assessment parameters
Key exclusion criteria (5 listed)
- Presence of neurodegenerative disease (dementia, parkinsonism)
- Immobilized patient
- Those who have had an acute illness (infection, fracture, cerebrovascular disease) in the last month
- Having psychotic disorders
- Having severe hearing loss
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 |
|---|---|---|
| Detailed geriatric assessmentThe demographic characteristics of the patients, comorbid diseases, history and number of falls in the last 6 months will be questioned, and the thyroid stimulating hormone, calciferol, cobalamin, glycosylated hemoglobin, folic acid and glomerular filtration rate levels routinely requested from each patient in the last 3 months will be recorded. During the outpatient clinic application, the patients will undergo neurocognitive assessment, mood assessment, daily living activities assessment, balance and walking assessment, nutritional assessment and frailty assessment. The patients' handgrip strength from their dominant hand will be assessed with a hand dynamometer. The walking speed of the patients will be measured as the number of seconds it takes to walk 4 meters and recorded in seconds. All patients will be questioned about the presence of body pain with the numerical pain scale score and all patients will be evaluated for the presence of fibromyalgia syndrome. | Other | Elderly Patients |
Primary outcome
Presence of fibromyalgia syndrome
Time frame: Baseline
The presence of fibromyalgia will be evaluated using the 2016 American College of Rheumatology diagnostic criteria.
7 secondary outcomes
Neurocognitive assessment
Time frame: Baseline
Mood assessment
Time frame: Baseline
Daily living activities
Time frame: Baseline
Balance and walking assessment
Time frame: Baseline
Nutritional assessment
Time frame: Baseline
Frailty
Time frame: Baseline
Activities of daily living
Time frame: Baseline
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 20 Mar 2026.
- Individual participant dataSharing planned: Yes. If requested, the data of the study will be shared by the researchers.
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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.
Kübra Altunkalem Seydi, MD principal investigator
Sultan 1. Murat State Hospital
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 and Old Age; Debility, run by Sultan 1. Murat State Hospital 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 2 inclusion and 5 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 20 Mar 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?
Presence of fibromyalgia syndrome (time frame: Baseline). 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 20 Mar 2026.