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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary outcome', 'timeFrame': 'baseline', 'description': 'Frailty status determined according to the Fried Frailty Criteria (Frailty Phenotype).\n\nFrailty 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.'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome', 'timeFrame': 'baseline', 'description': 'Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain severity.'}, {'measure': 'Secondary Outcome Measure', 'timeFrame': 'baseline', 'description': 'Pain type classification (neuropathic, nociceptive, or mixed), assessed at baseline'}, {'measure': 'Secondary outcome meaaure', 'timeFrame': 'Baseline', 'description': 'Number of regularly used medications (polypharmacy status).'}, {'measure': 'Secondary outcome', 'timeFrame': 'Baseline', 'description': 'Pain duration -months'}, {'measure': 'Secondary outcome', 'timeFrame': 'During the 3-month follow-up period.', 'description': 'Type of pain treatment administered. Categorized as pharmacological, interventional, or combined therapy.'}, {'measure': 'Secondary outcome', 'timeFrame': '3 months.', 'description': 'Treatment response. Defined as clinically meaningful pain reduction (≥50% decrease in VAS score compared to baseline).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronical pain', 'neuropathic pain', 'Nociceptive Pain'], 'conditions': ['Geriatric Pain']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Saito, Takafumi, et al. "Relationship between chronic pain types (nociceptive and neuropathic-like symptoms) and frailty in community-dwelling Japanese older adults: A cross-sectional study." Journal of Pain Research (2023): 2675-2684.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nFrailty 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.\n\nThe 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:\n\nGNRI = (1.489 × serum albumin \\[g/L\\]) + (41.7 × current body weight / ideal body weight).\n\nThis score will be analyzed in relation to frailty status to evaluate nutritional risk.\n\nAs 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.\n\nAll 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.\n\nFrailty 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.\n\nThe 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:\n\nGNRI = (1.489 × serum albumin \\[g/L\\]) + (41.7 × current body weight / ideal body weight).\n\nThis score will be analyzed in relation to frailty status to evaluate nutritional risk.\n\nAs 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have chronical pain for more than months and older than 65 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 65 years or older Diagnosis of chronic pain (duration \\> 3 months)\n\nExclusion Criteria:\n\nAcute pain complaint Pain related to malignancy Severe communication impairment'}, 'identificationModule': {'nctId': 'NCT07373860', 'acronym': 'F&P', 'briefTitle': 'Frailty and Chronic Pain Profiles in Patients Aged ≥65 Years', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TABED-1-25-1637'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly Chronic Pain Cohort', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Cankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ulku Sabuncu, Assoc prof', 'role': 'CONTACT', 'email': 'sabuncuulku@gmail.com', 'phone': '905337085212'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ulku Sabunccu, Assoc. Prof.', 'role': 'CONTACT', 'email': 'sabuncuulku@gmail.com', 'phone': '+905337085212'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof.', 'investigatorFullName': 'Ülkü Sabuncu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}