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

Recruiting

• Conditions: Rheumatoid Arthritis; Rheumatic Diseases; Rheumatoid Polyarthritis
• Interventions: Other: Questionnaire and physical assessments

• Registration Number: NCT05934721
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Study Start: 2023-07-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients aged 70-90 years	Questionnaire and physical assessments	Patients meeting inclusion/exclusion criteria will be recruited from rheumatology clinics and community sources.

Primary Outcome Measures

Name	Time	Method
RA disease severity as measured by the Physician Global Assessment (0-10 VAS)	Baseline	Description: 0 = no disease activity; 10 = maximum disease activity
Cognitive function as measured by the Montreal Cognitive Assessment (MoCA)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment (0-10 VAS)	Baseline	Self-report of RA severity; 0 = no disease activity; 10 = maximum disease activity
Inflammatory markers (ESR)	Baseline	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.
Inflammatory markers (CRP)	Baseline	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.
28-joint swollen/tender joint count	Baseline	Number of joints with swelling/tenderness on examination

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt