- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487610
Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
Evaluation of the Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alper Mengi, MD
- Phone Number: +90 537 651 03 85
- Email: dralpmengi@gmail.com
Study Locations
-
-
-
Edirne, Turkey (Türkiye), 22030
- Recruiting
- Sultan 1. Murat State Hospital
-
Contact:
- Alper Mengi
- Phone Number: +90 5537 651 03 85
- Email: dralpmengi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Kübra Altunkalem Seydi, MD, Sultan 1. Murat State Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29/12/2025-Number:13/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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