Psychological and Pain Factors in Knee Osteoarthritis

Associations Between Psychological Factors, Pain Sensitivity, and Physical Function in Knee Osteoarthritis: a One-year Follow up Study

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Diagnostic test: WOMAC pain subscale

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical knee osteoarthritis experiencing persistent knee pain.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Knee Osteoarthritis; Patients with physician-diagnosed knee osteoarthritis

Diagnostic test: WOMAC pain subscale; The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale is a self-reported questionnaire that is used to measure pain in people with osteoarthritis (OA). The subscale consists of five items that ask about the intensity, frequency, and duration of pain in the hip and knee joints. The WOMAC Pain Subscale has been shown to be a reliable and valid measure of pain in people with OA. It has been used in a number of clinical trials and is considered to be a standard measure of pain in OA. The WOMAC Pain Subscale is scored on a scale of 0 to 4, with 0 indicating no pain and 4 indicating severe pain. The total score for the subscale is the sum of the scores for the five items. A higher score indicates more pain.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Knee OA Study 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No