Ankara Bilkent City Hospital
Ankara, Cankaya, Turkey (Türkiye)
NCT Number: NCT07373860
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.
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Notify Me65 year and older
All sexes
Observational
Ankara, Cankaya, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
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.
Time frame: baseline
Pain type classification (neuropathic, nociceptive, or mixed), assessed at baseline
Time frame: Baseline
Number of regularly used medications (polypharmacy status).
Time frame: Baseline
Pain duration -months
Time frame: During the 3-month follow-up period.
Type of pain treatment administered. Categorized as pharmacological, interventional, or combined therapy.
Time frame: 3 months.
Treatment response. Defined as clinically meaningful pain reduction (≥50% decrease in VAS score compared to baseline).
Ankara City Hospital Bilkent
Other
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
Acronym: F&P
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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