Rheumatoid ArthritisNCT05934721
Relationship Between Rheumatoid Arthritis Severity and Cognition in the Elderly: The Role of Nociplastic Pain
An observational study of Rheumatoid Arthritis and Rheumatic Diseases, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (RA) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing RA and assess their disease severity, cognition, and pain sensitization will be recruited. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatic Diseases, Rheumatoid Polyarthritis
- What is being tested?
- Questionnaire and physical assessments
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 31 Dec 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Community-dwelling adults aged 65-90 years with a diagnosis of RA for 10-30 years who meet the ACR/EULAR 2010 classification criteria.
Who may be able to join
- Age 65-90 years
- diagnosed with RA for 10-30 years
- meet ACR/EULAR 2010 criteria
Who cannot join
- Other inflammatory arthritides
- dementia
- severe depression
- recent corticosteroid or immunosuppressant use
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: The Mediating Effect of Nociplastic Pain on the Relationship Between Rheumatoid Arthritis Severity and Cognition in Geriatric Patients: A Cross-Sectional Study
this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (RA) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing RA and assess their disease severity, cognition, and pain sensitization will be recruited. Expectations that patients with more severe RA will have worse cognitive function, and that this relationship will be mediated by higher levels of nociplastic pain.
- Being tested
- Questionnaire and physical assessments
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and physical assessmentsOther
Participants will complete self-report questionnaires assessing pain (CSI) and RA severity (patient global VAS), as well as undergoing physical assessments of RA severity (physician global VAS, swollen/tender joint counts) and cognition (MoCA).
| Study group | Role | What they receive |
|---|---|---|
| RA patients aged 70-90 years | Patients meeting inclusion/exclusion criteria will be recruited from rheumatology clinics and community sources. Receives: Other: Questionnaire and physical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
The MoCA assessments cognition in multiple domains; scores ≤26 indicate cognitive impairment. The MoCA is scored out of 30 points, with a higher score indicating better cognitive function. The maximum score on the MoCA is 30, while the minimum score is 0. The test typically takes around 10-15 minutes to complete and is administered by a trained healthcare professional.
Measured: Baseline
Centralized pain as measured by the Central Sensitization Inventory (CSI)
The CSI determines the degree of pain centralization/sensitization. The CSI consists of 25 items that assess various symptoms and experiences associated with CSS, including pain severity and quality, sleep disturbances, fatigue, mood changes, and cognitive difficulties. The CSI is scored on a 0-100 scale, with higher scores indicating a greater degree of central sensitization. A score of 40 or higher is generally considered to indicate the presence of CSS, while a score of 60 or higher indicates a high degree of central sensitization.
Measured: Baseline
RA disease severity as measured by the Physician Global Assessment (0-10 VAS)
Description: 0 = no disease activity; 10 = maximum disease activity
Measured: Baseline
Secondary outcomes (4)
28-joint swollen/tender joint count
Number of joints with swelling/tenderness on examination
Measured: Baseline
Patient Global Assessment (0-10 VAS)
Self-report of RA severity; 0 = no disease activity; 10 = maximum disease activity
Measured: Baseline
Inflammatory markers (ESR)
Markers of inflammation measured through blood tests. ESR is a blood test that measures how quickly red blood cells settle to the bottom of a test tube over a period of one hour. Inflammation in the body can cause red blood cells to clump together, which slows down their settling rate and leads to an elevated ESR. ESR is measured in millimeters per hour (mm/h), and normal values vary depending on age and gender. In general, higher ESR values indicate the presence of inflammation.
Measured: Baseline
Inflammatory markers (CRP)
Markers of inflammation measured through blood tests. CRP is a protein that is produced by the liver in response to inflammation in the body. CRP levels can rise rapidly in response to inflammation, and the test is commonly used to monitor the progression of inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. CRP is measured in milligrams per liter (mg/L), and normal values vary depending on age and gender. Higher CRP levels indicate the presence of inflammation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934721
- Sponsor's protocol ID
- 012/282023062023
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Effect of Nociplastic Pain on the Relationship Between Rheumatoid Arthritis Severity and Cognition in Geriatric Patients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05934721
- Acronym / sponsor ID
- 012/282023062023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jul 2023 (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.
this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (RA) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing RA and assess their disease severity, cognition, and pain sensitization will be recruited. Expectations that patients with more severe RA will have worse cognitive function, and that this relationship will be mediated by higher levels of nociplastic pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients aged 70-90 years | – | Other: Questionnaire and physical assessmentsPatients meeting inclusion/exclusion criteria will be recruited from rheumatology clinics and community sources. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community-dwelling adults aged 65-90 years with a diagnosis of RA for 10-30 years who meet the ACR/EULAR 2010 classification criteria.
Key inclusion criteria (3 listed)
- Age 65-90 years
- diagnosed with RA for 10-30 years
- meet ACR/EULAR 2010 criteria
Key exclusion criteria (4 listed)
- Other inflammatory arthritides
- dementia
- severe depression
- recent corticosteroid or immunosuppressant use
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 |
|---|---|---|
| Questionnaire and physical assessmentsParticipants will complete self-report questionnaires assessing pain (CSI) and RA severity (patient global VAS), as well as undergoing physical assessments of RA severity (physician global VAS, swollen/tender joint counts) and cognition (MoCA). | Other | RA patients aged 70-90 years |
Primary outcome
Cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
The MoCA assessments cognition in multiple domains; scores ≤26 indicate cognitive impairment. The MoCA is scored out of 30 points, with a higher score indicating better cognitive function. The maximum score on the MoCA is 30, while the minimum score is 0. The test typically takes around 10-15 minutes to complete and is administered by a trained healthcare professional.
Centralized pain as measured by the Central Sensitization Inventory (CSI)
Time frame: Baseline
The CSI determines the degree of pain centralization/sensitization. The CSI consists of 25 items that assess various symptoms and experiences associated with CSS, including pain severity and quality, sleep disturbances, fatigue, mood changes, and cognitive difficulties. The CSI is scored on a 0-100 scale, with higher scores indicating a greater degree of central sensitization. A score of 40 or higher is generally considered to indicate the presence of CSS, while a score of 60 or higher indicates a high degree of central sensitization.
RA disease severity as measured by the Physician Global Assessment (0-10 VAS)
Time frame: Baseline
Description: 0 = no disease activity; 10 = maximum disease activity
4 secondary outcomes
28-joint swollen/tender joint count
Time frame: Baseline
Patient Global Assessment (0-10 VAS)
Time frame: Baseline
Inflammatory markers (ESR)
Time frame: Baseline
Inflammatory markers (CRP)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
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 Rheumatoid Arthritis and Rheumatic Diseases, run by Ahram Canadian University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jul 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function as measured by the Montreal Cognitive Assessment (MoCA) (time frame: Baseline). The study lists 3 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 7 Jul 2023.