Psychological and Pain Factors in Knee Osteoarthritis

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Diagnostic Test: WOMAC pain subscale

• Registration Number: NCT05949489
• Lead Sponsor: Ahram Canadian University

Brief Summary

This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study Start: 2023-07-15
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
• Pain in or around the knee on most days of the past month
• Aged 40 years or above
• Ambulatory with or without walking aid

Exclusion Criteria

• Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
• Recent knee injury or surgery (past 3 months)
• Severe comorbidity likely to prevent study completion (dementia, terminal illness)
• inability to comply with study procedures or follow up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee Osteoarthritis	WOMAC pain subscale	Patients with physician-diagnosed knee osteoarthritis

Primary Outcome Measures

Name	Time	Method
Change in Physical Function from Baseline to 1 year (WOMAC)	Change from baseline at 1 year	Assessed using the WOMAC physical function subscale (0-68 scale, higher = worse function)

Secondary Outcome Measures

Name	Time	Method
Kinesiophobia	Change from baseline at 1 year	Assessed using the Tampa Scale of Kinesiophobia (17-68 scale, higher = higher kinesiophobia)
Pain Catastrophizing Scale	Change from baseline at 1 year	Assessed using the Pain Catastrophizing Scale (0-52 scale, higher = higher catastrophizing)
Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)	Change from baseline at 1 year	Assessed using the Pittsburgh Sleep Quality Index (0-21 scale, higher = worse sleep quality)
Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)	Change from baseline at 1 year	Assessed using the Pain Self-Efficacy Questionnaire (0-60 scale, higher = stronger self-efficacy beliefs)

Trial Locations

Locations (1)

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