Chronic PainNCT06672003
Assessing the Relationship Between Chronic Pain and Frailty in Older Adults
An observational study of Chronic Pain and Frailty, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Frailty
- What is being tested?
- 4 meter walking speed and hand grip strength
- How many people
- 203 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Patients with chronic pain who are registered with a family medicine unit
Who cannot join
- Having an active malignancy,
- having a physical disability,
- being bedridden,
- having a psychotic disorder,
- having a cognitive disorder, and refusing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain, Frailty
- Being tested
- 4 meter walking speed and hand grip strength
- Medical subject headings
- Chronic Pain, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 meter walking speed and hand grip strengthDiagnostic test
4 meter walking seconds are noteed for each of participants
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty
Participants' frailty levels will be determined.
Measured: 12 months
chronic pain
The relationship between participants' frailty levels and chronic pain frequency will be examined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672003
- Sponsor's protocol ID
- MCBU-SM-FM-01
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request of the board
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevelance of Chronic Pain and Its Relationship to Frailty in Older Adults
- ClinicalTrials.gov ID
- NCT06672003
- Acronym / sponsor ID
- MCBU-SM-FM-01
- Conditions
- Chronic Pain, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Nov 2024 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with chronic pain who are registered with a family medicine unit
Key exclusion criteria (5 listed)
- Having an active malignancy,
- having a physical disability,
- being bedridden,
- having a psychotic disorder,
- having a cognitive disorder, and refusing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 meter walking speed and hand grip strength4 meter walking seconds are noteed for each of participants | Diagnostic test | – |
Primary outcome
frailty
Time frame: 12 months
Participants' frailty levels will be determined.
chronic pain
Time frame: 6 months
The relationship between participants' frailty levels and chronic pain frequency will be examined.
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 10 Apr 2025.
- Individual participant dataSharing planned: Undecided. upon request of the board
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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 Chronic Pain and Frailty, run by Manisa Celal Bayar University 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 5 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 10 Apr 2025. 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?
frailty (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.