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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients aged 70-90 years | Patients meeting inclusion/exclusion criteria will be recruited from rheumatology clinics and community sources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire and physical assessments | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| RA disease severity as measured by the Physician Global Assessment (0-10 VAS) | Description: 0 = no disease activity; 10 = maximum disease activity | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 28-joint swollen/tender joint count | Number of joints with swelling/tenderness on examination | Baseline |
| Patient Global Assessment (0-10 VAS) | Self-report of RA severity; 0 = no disease activity; 10 = maximum disease activity |
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Inclusion Criteria:
Exclusion Criteria:
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Community-dwelling adults aged 65-90 years with a diagnosis of RA for 10-30 years who meet the ACR/EULAR 2010 classification criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed M ElMeligie, Ph.d | Contact | +201064442032 | mohamed.elmeligie@acu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amal Fawzy, Ph.d | Faculty of Physical Therapy, Ahram Canadian University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of faculty of physical therapy, Ahram Canadian University | Recruiting | Al Ḩayy Ath Thāmin | Giza Governorate | 3221405 | Egypt |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. | 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. | Baseline |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |