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Relationship Between Rheumatoid Arthritis Severity and Cognition in the Elderly: The Role of Nociplastic Pain

The Mediating Effect of Nociplastic Pain on the Relationship Between Rheumatoid Arthritis Severity and Cognition in Geriatric Patients: A Cross-Sectional Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05934721
Enrollment
100
Registered
2023-07-07
Start date
2023-07-15
Completion date
2023-12-31
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Diseases, Rheumatoid Arthritis, Rheumatoid Polyarthritis

Brief 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. 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.

Interventions

OTHERQuestionnaire and physical assessments

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).

Sponsors

Ahram Canadian University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age 65-90 years * diagnosed with RA for 10-30 years * meet ACR/EULAR 2010 criteria

Exclusion criteria

* Other inflammatory arthritides * dementia * severe depression * recent corticosteroid or immunosuppressant use

Design outcomes

Primary

MeasureTime frameDescription
Cognitive function as measured by the Montreal Cognitive Assessment (MoCA)BaselineThe 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)BaselineThe 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)BaselineDescription: 0 = no disease activity; 10 = maximum disease activity

Secondary

MeasureTime frameDescription
28-joint swollen/tender joint countBaselineNumber of joints with swelling/tenderness on examination
Inflammatory markers (CRP)BaselineMarkers 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.
Patient Global Assessment (0-10 VAS)BaselineSelf-report of RA severity; 0 = no disease activity; 10 = maximum disease activity
Inflammatory markers (ESR)BaselineMarkers 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.

Countries

Egypt

Contacts

Primary ContactMohamed M ElMeligie, Ph.d
mohamed.elmeligie@acu.edu.eg+201064442032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026