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

NCT05934721 | Unknown

• 1 other identifier: 012/282023062023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Rheumatic Diseases; Rheumatoid Polyarthritis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• 28-joint swollen/tender joint count

  Baseline

• Patient Global Assessment (0-10 VAS)

  Baseline

• Inflammatory markers (ESR)

  Baseline

• Inflammatory markers (CRP)

  Baseline

Study Arms (1)

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

Interventions

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).

RA patients aged 70-90 years

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling adults aged 65-90 years with a diagnosis of RA for 10-30 years who meet the ACR/EULAR 2010 classification criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: July 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)