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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934721
• Other study ID #: 012/282023062023
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis
• Rheumatoid Polyarthritis

Intervention

Other:
• Questionnaire 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).

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	RA disease severity as measured by the Physician Global Assessment (0-10 VAS)	Description: 0 = no disease activity; 10 = maximum disease activity	Baseline
Secondary	28-joint swollen/tender joint count	Number of joints with swelling/tenderness on examination	Baseline
Secondary	Patient Global Assessment (0-10 VAS)	Self-report of RA severity; 0 = no disease activity; 10 = maximum disease activity	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline