NCT07487610

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

March 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of neuropathic pain

    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 Outcomes (7)

  • Pain intensity

    Baseline

  • Mood status

    Baseline

  • Daily living activities

    Baseline

  • Activities of daily living

    Baseline

  • Neurocognitive assessment

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

patients without neuropathic pain

Patients with a total score of 4 or higher according to the Douleur Neuropathique 4 (DN4)

Other: Detailed geriatric assessment

Patients without neuropathic pain

Patients with a total DN4 score below 4

Other: Detailed geriatric assessment

Interventions

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 painpatients without neuropathic pain

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

NeuralgiaFrailtyPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Kübra Altunkalem Seydi, MD

    Sultan 1. Murat State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 17, 2026

Primary Completion

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Locations