- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06672003
Assessing the Relationship Between Chronic Pain and Frailty in Older Adults
April 9, 2025 updated by: Celal Bayar University
Assessment of the Prevelance of Chronic Pain and Its Relationship to Frailty in Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
203
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Manisa, Turkey
- Manisa Celal Bayar University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- Patients with chronic pain who are registered with a family medicine unit
Exclusion Criteria:
- Having an active malignancy,
- having a physical disability,
- being bedridden,
- having a psychotic disorder,
- having a cognitive disorder, and refusing to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frailty
Time Frame: 12 months
|
Participants' frailty levels will be determined.
|
12 months
|
|
chronic pain
Time Frame: 6 months
|
The relationship between participants' frailty levels and chronic pain frequency will be examined.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
August 9, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Actual)
November 4, 2024
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU-SM-FM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
upon request of the board
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.