Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-28 @ 9:31 PM
Study NCT ID:
NCT06672003
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Relationship Between Chronic Pain and Frailty in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018737', 'term': 'Hand Strength'}], 'ancestors': [{'id': 'D053580', 'term': 'Muscle Strength'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-16', 'size': 566597, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-16T08:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frailty', 'timeFrame': '12 months', 'description': "Participants' frailty levels will be determined."}, {'measure': 'chronic pain', 'timeFrame': '6 months', 'description': "The relationship between participants' frailty levels and chronic pain frequency will be examined."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Frailty']}, 'descriptionModule': {'briefSummary': "Pain is an unpleasant emotional sensation related to one's past experiences, originating from a certain part of the body, due to tissue damage or not. Pain is the most commonly reported symptom in the elderly. Chronic pain is persistent or recurrent pain lasting more than 3 months. It is a maladaptive process or a disease that requires multimodal treatment that causes functional decline, independent of the healing process, accompanied by affective, cognitive and motivational disorders, and deterioration in quality of life. Frailty: It is defined as a clinical condition characterized by weakness, physical disability, functional regression, inadequacy in activities of daily living, and increased dependence, which develops as a result of the decrease in physiological reserves in the body with age. It has been reported that the risk of falls, disability, hospitalization and premature death is higher in the frail elderly. The prevalence of vulnerability in societies varies. Frailty rates ranging from 4 to 59% have been reported in developed and developing countries. In this study, it was aimed to evaluate whether there is a relationship between chronic pain and frailty in individuals aged 65 and over."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The universe of the study consists of all individuals aged 65 and over registered in a family health center. Participants to be included in the study from this universe will be determined using the stratified random sampling method.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic pain who are registered with a family medicine unit\n\nExclusion Criteria:\n\n* Having an active malignancy,\n* having a physical disability,\n* being bedridden,\n* having a psychotic disorder,\n* having a cognitive disorder, and refusing to participate.'}, 'identificationModule': {'nctId': 'NCT06672003', 'briefTitle': 'Assessing the Relationship Between Chronic Pain and Frailty in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': 'Assessment of the Prevelance of Chronic Pain and Its Relationship to Frailty in Older Adults', 'orgStudyIdInfo': {'id': 'MCBU-SM-FM-01'}}, 'armsInterventionsModule': {'interventions': [{'name': '4 meter walking speed and hand grip strength', 'type': 'DIAGNOSTIC_TEST', 'description': '4 meter walking seconds are noteed for each of participants'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Manisa Celal Bayar University', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon request of the board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}