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

March 17, 2026 updated by: Alper Mengi, Sultan 1. Murat State Hospital

Evaluation of the 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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients without neuropathic pain
Patients with a total score of 4 or higher according to the Douleur Neuropathique 4 (DN4)

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.

Patients without neuropathic pain
Patients with a total DN4 score below 4

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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."
Baseline
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".
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kübra Altunkalem Seydi, MD, Sultan 1. Murat State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If requested, the data of the study will be shared by the researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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