Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:52 AM
Study NCT ID:
NCT07373860
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty and Chronic Pain Profiles in Patients Aged ≥65 Years
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
F&P
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: