Frailty and Chronic Pain Profiles in Patients Aged ≥65 Years (F&P)
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cankaya
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Ankara, Cankaya, Turkey (Türkiye)
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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primary outcome
Time Frame: baseline
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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
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Secondary Outcome Measures
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.
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baseline
|
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Secondary Outcome Measure
Time Frame: baseline
|
Pain type classification (neuropathic, nociceptive, or mixed), assessed at baseline
|
baseline
|
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Secondary outcome meaaure
Time Frame: Baseline
|
Number of regularly used medications (polypharmacy status).
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Baseline
|
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Secondary outcome
Time Frame: Baseline
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Pain duration -months
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Baseline
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Secondary outcome
Time Frame: During the 3-month follow-up period.
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Type of pain treatment administered.
Categorized as pharmacological, interventional, or combined therapy.
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During the 3-month follow-up period.
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Secondary outcome
Time Frame: 3 months.
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Treatment response.
Defined as clinically meaningful pain reduction (≥50% decrease in VAS score compared to baseline).
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3 months.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- TABED-1-25-1637
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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