Sultan 1. Murat State Hospital
Edirne, 22030, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07487610
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.
Interested in participating?
Request Info80 year and older
All sexes
Observational
Edirne, 22030, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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."
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.
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.
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.
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".
Contact information is provided by the study sponsor or research team.
Sultan 1. Murat State Hospital
Other Gov
Evaluation of the Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
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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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