About this trial
This study aims to evaluate the reliability and convergent validity of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) in patients with knee osteoarthritis (KOA). Pain self-efficacy refers to a person's confidence in managing their pain and maintaining daily activities despite it.
A total of 173 patients with KOA will be recruited at Gia Dinh People's Hospital using a convenient sampling method. Eligible participants are 50 years or older, diagnosed with KOA, and experiencing chronic knee pain. They will complete the VIET-PSEQ and other health-related questionnaires during an in-person interview.
The study will assess internal consistency (using Cronbach's alpha), test-retest reliability (by re-assessing a subgroup after 72 hours), and convergent validity by correlating VIET-PSEQ scores with EQ-5D-5L utility index. Additionally, linear regression analysis will examine how age, sex, pain severity, and education level influence pain self-efficacy.
The goal is to determine whether VIET-PSEQ is a reliable and valid tool for measuring pain self-efficacy in Vietnamese patients with KOA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 50 years.
application of ACR criteria by the investigator at the time of enrollment; or
a prior diagnosis documented in medical records by a rheumatologist or musculoskeletal specialist.
Presence of chronic pain related to knee OA, with current pain intensity ≥ 1 on the Visual Analog Scale (VAS).
Disqualifiers
Diagnosis of severe psychiatric disorders (e.g., schizophrenia, severe anxiety disorders).
Presence of cognitive impairment that interferes with the ability to comprehend or answer the questionnaire.
Diagnosed with systemic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, or gout.
Presence of other chronic pain conditions (unrelated to knee OA) that are predominant and significantly affect mobility and daily functioning.
Trial population
The study population will consist of adults aged 50 years and older diagnosed with knee osteoarthritis, either newly confirmed at the time of enrollment using the American College of Rheumatology (ACR) criteria or previously diagnosed and documented in the medical records by a specialist. Participants will be recruited from outpatient departments in urban hospitals in Vietnam. The population includes patients with chronic knee pain related to osteoarthritis who are able to perform daily activities and comprehend written Vietnamese.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)
Other interventionParticipants completed the Vietnamese version of the Pain Self-Efficacy Questionnaire (PSEQ) to assess self-efficacy beliefs related to pain management.
Treatment groups
Trial outcomes
Primary outcomes
Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ)
The primary outcomes are the internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) among patients with knee osteoarthritis. Internal consistency will be assessed using Cronbach's alpha with a threshold of ≥ 0.70. Test-retest reliability will be evaluated using the intraclass correlation coefficient (ICC) calculated from a two-way random-effects model with absolute agreement, based on repeated assessments 3 days apart without clinical intervention.
Secondary outcomes
Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score
To assess the convergent validity of the VIET-PSEQ by analyzing its correlation with the EQ-5D-5L utility index. This aims to explore the association between pain self-efficacy and health-related quality of life in patients with knee osteoarthritis. Correlation will be examined using Spearman's rho or Pearson's r depending on data distribution.
Other outcomes
Regression analysis of predictors of total VIET PSEQ score
Linear regression will be conducted to evaluate the association between total VIET PSEQ score and potential predictors including age, gender, pain intensity (VAS), and education level. Assumptions of the linear model will be tested. In case of non-normal distribution, data transformation or alternative models such as quantile regression will be considered.
Sponsors and contacts
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Khai Quang Nguyen, MD
Lead sponsor
Gia Dinh People Hospital
Sponsor institution