NCT06672003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

August 9, 2024

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • frailty

    Participants' frailty levels will be determined.

    12 months

  • chronic pain

    The relationship between participants' frailty levels and chronic pain frequency will be examined.

    6 months

Interventions

4 meter walking seconds are noteed for each of participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Patients with chronic pain who are registered with a family medicine unit

You may not qualify if:

  • Having an active malignancy,
  • having a physical disability,
  • being bedridden,
  • having a psychotic disorder,
  • having a cognitive disorder, and refusing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainFrailty

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

November 4, 2024

Study Start

November 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations