Psychological and Pain Factors in Knee Osteoarthritis

July 14, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
        • Recruiting
        • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: Change from baseline at 1 year
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
Time Frame: Change from baseline at 1 year
Assessed using the Pain Catastrophizing Scale (0-52 scale, higher = higher catastrophizing)
Change from baseline at 1 year
Kinesiophobia
Time Frame: Change from baseline at 1 year
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)
Time Frame: Change from baseline at 1 year
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)
Time Frame: Change from baseline at 1 year
Assessed using the Pain Self-Efficacy Questionnaire (0-60 scale, higher = stronger self-efficacy beliefs)
Change from baseline at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahram Canadian University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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