Psychological and Pain Factors in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949489
• Other study ID #: Knee OA Study 01
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Catastrophizing Scale	Assessed using the Pain Catastrophizing Scale (0-52 scale, higher = higher catastrophizing)	Change from baseline at 1 year
Secondary	Kinesiophobia	Assessed using the Tampa Scale of Kinesiophobia (17-68 scale, higher = higher kinesiophobia)	Change from baseline at 1 year
Secondary	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
Secondary	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