Psychological and Pain Factors in Knee Osteoarthritis

NCT05949489 | Unknown

• 1 other identifier: Knee OA Study 01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Catastrophizing Scale

  Change from baseline at 1 year

• Kinesiophobia

  Change from baseline at 1 year

• Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)

  Change from baseline at 1 year

• Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)

  Change from baseline at 1 year

Study Arms (1)

Knee Osteoarthritis

Patients with physician-diagnosed knee osteoarthritis

Diagnostic Test: WOMAC pain subscale

Interventions

WOMAC pain subscale DIAGNOSTIC_TEST

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.

Knee Osteoarthritis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical knee osteoarthritis experiencing persistent knee pain.

You may qualify if:

• 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

You may not qualify if:

• 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

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

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 18, 2023
• Study Start: July 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)