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NCT Number: NCT07487610

Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older

This study aimed to determine the frequency of neuropathic pain in individuals aged 80 years and older and to evaluate the relationship between neuropathic pain and comprehensive geriatric assessment parameters.

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 80 years or older
  • Full cooperation
  • Complete comprehensive geriatric assessment parameters

Exclusion criteria

  • Patients with dementia classified as CDR-2 or CDR-3 according to the Clinical Dementia Rating (CDR) Scale
  • Patients who have experienced an acute illness within the last 1 month (e.g., infection, fracture, or cerebrovascular disease)
  • Patients with a psychotic disorder
  • Patients with severe hearing loss
  • Patients with a history of malignancy

Treatment and study plan

Detailed geriatric assessment

Other

The patients' demographic characteristics, comorbid diseases, and laboratory parameters routinely requested from each patient within the last 3 months, including TSH, vitamin D, vitamin B12, HbA1c, hemoglobin, folic acid, and GFR levels, will be recorded.

During the outpatient clinic visit, the presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and the average pain severity over the last week will be recorded. The use of medications that may affect pain severity and that have been used regularly by the patients for the last 3 months will also be assessed (antiepileptics, nonsteroidal anti-inflammatory drugs, paracetamol, and antidepressants).

The patients will undergo mood assessment, evaluation of basic and instrumental activities of daily living, neurocognitive assessment, frailty assessment, and nutritional assessment.

Primary outcomes

  1. Presence of neuropathic pain

    Time frame: Baseline

    The presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. The DN4 consists of 10 items. The first 7 items evaluate the characteristics and sensory quality of pain, whereas the remaining 3 items are based on physical examination findings. A total score of 4 or higher is defined as the presence of neuropathic pain, while a score below 4 is defined as the absence of neuropathic pain.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline

    Patients' pain intensity will be assessed using the Visual Analog Scale (VAS). In the VAS assessment, a 10-cm horizontal straight line will be used, where 0 indicates no pain and 10 indicates unbearable pain. Using the VAS, the average pain intensity during the last week will be recorded.

  2. Mood status

    Time frame: Baseline

    Mood status will be assessed using the short form of the Yesavage Geriatric Depression Scale. The short form consists of 15 questions to which patients respond with "yes" or "no." Scoring is based on the number of depressive responses, and the total score is used to determine the level of depression. Scores of 0-9 are considered "normal," scores of 10-19 indicate "mild depression," and scores of 20-30 indicate "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. 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.

  5. 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.

  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. 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Alper Mengi, MD

CONTACT

[email protected]

+90 537 651 03 85

Sponsors and collaborators

Lead sponsor

Sultan 1. Murat State Hospital

Other Gov

Registry information

Official study title

Evaluation of the Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 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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