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

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05934721
Collaborator
(none)
100
1
5.6
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire and physical assessments

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Mediating Effect of Nociplastic Pain on the Relationship Between Rheumatoid Arthritis Severity and Cognition in Geriatric Patients: A Cross-Sectional Study
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
RA patients aged 70-90 years

Patients meeting inclusion/exclusion criteria will be recruited from rheumatology clinics and community sources.

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).

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. RA disease severity as measured by the Physician Global Assessment (0-10 VAS) [Baseline]

    Description: 0 = no disease activity; 10 = maximum disease activity

Secondary Outcome Measures

  1. 28-joint swollen/tender joint count [Baseline]

    Number of joints with swelling/tenderness on examination

  2. Patient Global Assessment (0-10 VAS) [Baseline]

    Self-report of RA severity; 0 = no disease activity; 10 = maximum disease activity

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

  • Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05934721
Other Study ID Numbers:
  • 012/282023062023
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023