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Completed

NCT Number: NCT06969716

Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Geriatric 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.

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 80 and above
  • Patients with complete detailed geriatric assessment parameters

Exclusion criteria

  • 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

Treatment and study plan

Detailed geriatric assessment

Other

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.

Primary outcomes

  1. Presence of fibromyalgia syndrome

    Time frame: Baseline

    The presence of fibromyalgia will be evaluated using the 2016 American College of Rheumatology diagnostic criteria.

Secondary outcomes

  1. Neurocognitive assessment

    Time frame: Baseline

    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.

  2. Mood assessment

    Time frame: Baseline

    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".

  3. Daily living activities

    Time frame: Baseline

    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."

  4. Balance and walking assessment

    Time frame: Baseline

    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.

  5. Nutritional assessment

    Time frame: Baseline

    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".

  6. Frailty

    Time frame: Baseline

    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.

  7. Activities of daily living

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Sultan 1. Murat State Hospital

Other Gov

Registry information

Official study title

Frequency of Fibromyalgia Syndrome in Elderly Patients Aged 80 and Above and Its Relationship With Detailed Geriatric Assessment Parameters

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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