Geriatric PainF&PNCT07373860
Frailty and Chronic Pain Profiles in Patients Aged ≥65 Years
An observational study of Geriatric Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Pain
- How many people
- 393 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 12 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who have chronical pain for more than months and older than 65 years old
Who may be able to join
- Age 65 years or older Diagnosis of chronic pain (duration > 3 months)
Who cannot join
- Acute pain complaint Pain related to malignancy Severe communication impairment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Geriatric Pain
- Keywords
- chronical pain, neuropathic pain, Nociceptive Pain
- Medical subject headings
- Neuralgia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
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.
Measured: baseline
Secondary outcomes (6)
Secondary outcome
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain severity.
Measured: baseline
Secondary Outcome Measure
Pain type classification (neuropathic, nociceptive, or mixed), assessed at baseline
Measured: baseline
Secondary outcome meaaure
Number of regularly used medications (polypharmacy status).
Measured: Baseline
Secondary outcome
Pain duration -months
Measured: Baseline
Secondary outcome
Type of pain treatment administered. Categorized as pharmacological, interventional, or combined therapy.
Measured: During the 3-month follow-up period.
Secondary outcome
Treatment response. Defined as clinically meaningful pain reduction (≥50% decrease in VAS score compared to baseline).
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 393 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Sabuncu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373860
- Sponsor's protocol ID
- TABED-1-25-1637
- Acronym
- F&P
- Status last verified
- May 2026
- First submitted
- 15 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saito T, Liu X, Yatsugi H, Chu T, Yokote T, Kishimoto H. Relationship Between Chronic Pain Types (Nociceptive and Neuropathic-Like Symptoms) and Frailty in Community-Dwelling Japanese Older Adults: A Cross-Sectional Study. J Pain Res. 2023 Aug 1;16:2675-2684. doi: 10.2147/JPR.S402002. eCollection 2023.
PubMed 37545692
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07373860
- Acronym / sponsor ID
- F&P / TABED-1-25-1637
- Conditions
- Geriatric Pain
- Keywords
- chronical pain, neuropathic pain, Nociceptive Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who have chronical pain for more than months and older than 65 years old
Key inclusion criteria (1 listed)
- Age 65 years or older Diagnosis of chronic pain (duration > 3 months)
Key exclusion criteria (1 listed)
- Acute pain complaint Pain related to malignancy Severe communication impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Secondary outcome
Time frame: baseline
Secondary Outcome Measure
Time frame: baseline
Secondary outcome meaaure
Time frame: Baseline
Secondary outcome
Time frame: Baseline
Secondary outcome
Time frame: During the 3-month follow-up period.
Secondary outcome
Time frame: 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 37545692Saito T, Liu X, Yatsugi H, Chu T, Yokote T, Kishimoto H. Relationship Between Chronic Pain Types (Nociceptive and Neuropathic-Like Symptoms) and Frailty in Community-Dwelling Japanese Older Adults: A Cross-Sectional Study. J Pain Res. 2023 Aug 1;16:2675-2684. doi: 10.2147/JPR.S402002. eCollection 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Geriatric Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.