Frailty and Chronic Pain Profiles in Patients Aged ≥65 Years (F&P)

May 12, 2026 updated by: Ülkü Sabuncu, Ankara City Hospital Bilkent

Investigation of the Relationship Between Frailty Status and Pain Type, Pain Localization, and GNRI in Individuals Aged 65 Years and Older With Chronic Pain Presenting to a Pain Clinic

The primary aim of this study is to investigate the relationship between frailty status and pain type, pain localization, and the Geriatric Nutritional Risk Index (GNRI) in individuals aged 65 years and older who present to an pain clinic with chronic pain. The secondary aim is to evaluate the level of interaction among these parameters and to contribute to a holistic approach to pain management in older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is an observational, cross-sectional investigation to be conducted in individuals aged 65 years and older who present to the algology outpatient clinic with complaints of chronic pain. Participation in the study will be entirely voluntary, and written informed consent will be obtained from all participants. Data collection will be carried out through face-to-face interviews with patients and retrospective review of patient medical records.

Frailty status of the participants will be assessed using the FRAIL Scale, which is widely used in the literature and has proven validity. Alternatively, the Fried Frailty Criteria may be used according to the researcher's preference. Based on these assessments, frailty status will be classified into three categories: robust, prefrail, and frail.

The Geriatric Nutritional Risk Index (GNRI), an objective indicator of nutritional status, will be calculated using participants' serum albumin levels, current body weight, and height according to the following formula:

GNRI = (1.489 × serum albumin [g/L]) + (41.7 × current body weight / ideal body weight).

This score will be analyzed in relation to frailty status to evaluate nutritional risk.

As part of pain assessment, pain intensity will be measured using the Visual Analog Scale (VAS). To determine pain type, the DN4 (Douleur Neuropathique 4) questionnaire and the painDETECT questionnaire, both of which have established validity for neuropathic pain assessment, will be administered. In addition, pain localization will be classified using a pain localization map, and multisite pain involvement will also be recorded.

All collected data will be recorded in encrypted data forms and stored digitally with access restricted to the research team only. Personal identifying information will not be used at any stage of the study, and full compliance with the principles of confidentiality and privacy will be ensured.This study is an observational, cross-sectional investigation to be conducted in individuals aged 65 years and older who present to the algology outpatient clinic with complaints of chronic pain. Participation in the study will be entirely voluntary, and written informed consent will be obtained from all participants. Data collection will be carried out through face-to-face interviews with patients and retrospective review of patient medical records.

Frailty status of the participants will be assessed using the FRAIL Scale, which is widely used in the literature and has proven validity. Alternatively, the Fried Frailty Criteria may be used according to the researcher's preference. Based on these assessments, frailty status will be classified into three categories: robust, prefrail, and frail.

The Geriatric Nutritional Risk Index (GNRI), an objective indicator of nutritional status, will be calculated using participants' serum albumin levels, current body weight, and height according to the following formula:

GNRI = (1.489 × serum albumin [g/L]) + (41.7 × current body weight / ideal body weight).

This score will be analyzed in relation to frailty status to evaluate nutritional risk.

As part of pain assessment, pain intensity will be measured using the Visual Analog Scale (VAS). To determine pain type, the DN4 (Douleur Neuropathique 4) questionnaire and the painDETECT questionnaire, both of which have established validity for neuropathic pain assessment, will be administered. In addition, pain localization will be classified using a pain localization map, and multisite pain involvement will also be recorded.

All collected data will be recorded in encrypted data forms and stored digitally with access restricted to the research team only. Personal identifying information will not be used at any stage of the study, and full compliance with the principles of confidentiality and privacy will be ensured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
393

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Cankaya
      • Ankara, Cankaya, Turkey (Türkiye)
        • Ankara Bilkent City Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have chronical pain for more than months and older than 65 years old

Description

Inclusion Criteria:

Age 65 years or older Diagnosis of chronic pain (duration > 3 months)

Exclusion Criteria:

Acute pain complaint Pain related to malignancy Severe communication impairment

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Elderly Chronic Pain Cohort
The Elderly Chronic Pain Cohort consisted of individuals aged 65 years and older who presented to the pain outpatient clinic with complaints of chronic pain and met the study inclusion criteria. All eligible participants were consecutively enrolled during the study period. Frailty status, nutritional risk, and pain-related characteristics were systematically assessed at baseline. Subgroup analyses were performed according to frailty statu

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
primary outcome
Time Frame: baseline

Frailty status determined according to the Fried Frailty Criteria (Frailty Phenotype).

Frailty will be classified as robust (0 criteria), pre-frail (1-2 criteria), or frail (≥3 criteria) based on the presence of unintentional weight loss, exhaustion, low physical activity, slowness, and weakness.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: baseline
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain severity.
baseline
Secondary Outcome Measure
Time Frame: baseline
Pain type classification (neuropathic, nociceptive, or mixed), assessed at baseline
baseline
Secondary outcome meaaure
Time Frame: Baseline
Number of regularly used medications (polypharmacy status).
Baseline
Secondary outcome
Time Frame: Baseline
Pain duration -months
Baseline
Secondary outcome
Time Frame: During the 3-month follow-up period.
Type of pain treatment administered. Categorized as pharmacological, interventional, or combined therapy.
During the 3-month follow-up period.
Secondary outcome
Time Frame: 3 months.
Treatment response. Defined as clinically meaningful pain reduction (≥50% decrease in VAS score compared to baseline).
3 months.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TABED-1-25-1637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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