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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05949489
Enrollment
150
Registered
2023-07-18
Start date
2023-07-15
Completion date
2024-07-15
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DIAGNOSTIC_TESTWOMAC 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.

Sponsors

Ahram Canadian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical Function from Baseline to 1 year (WOMAC)Change from baseline at 1 yearAssessed using the WOMAC physical function subscale (0-68 scale, higher = worse function)

Secondary

MeasureTime frameDescription
Pain Catastrophizing ScaleChange from baseline at 1 yearAssessed using the Pain Catastrophizing Scale (0-52 scale, higher = higher catastrophizing)
KinesiophobiaChange from baseline at 1 yearAssessed using the Tampa Scale of Kinesiophobia (17-68 scale, higher = higher kinesiophobia)
Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)Change from baseline at 1 yearAssessed 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 yearAssessed using the Pain Self-Efficacy Questionnaire (0-60 scale, higher = stronger self-efficacy beliefs)

Countries

Egypt

Contacts

Primary ContactMohamed M ElMeligie, Ph.d
mohamed.elmeligie@acu.edu.eg+201064442032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026