Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis

NCT07130630 | Recruiting

• 1 other identifier: 113/NDGĐ- HĐĐĐ
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis (Knee OA)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and follow-up at Day 3 for test-retest group

Secondary Outcomes (1)

• Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score

  At baseline assessment

Other Outcomes (1)

• Regression analysis of predictors of total VIET PSEQ score

  At baseline (upon enrollment)

Study Arms (1)

Patients with Knee Osteoarthritis

A single group of patients aged 50+ with clinically diagnosed knee osteoarthritis attending Gia Dinh People's Hospital for outpatient evaluation. Participants will complete the Vietnamese Pain Self-Efficacy Questionnaire (VIET-PSEQ) to assess its psychometric properties.

Other: Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)

Interventions

Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ) OTHER

Participants completed the Vietnamese version of the Pain Self-Efficacy Questionnaire (PSEQ) to assess self-efficacy beliefs related to pain management.

Patients with Knee Osteoarthritis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥ 50 years.
• Diagnosis of knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology (ACR), confirmed by:
• 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).
• No acute flare of knee pain within the past 2 weeks.
• Ability to perform activities of daily living (with or without assistance).
• Ability to read, understand, and complete questionnaires in Vietnamese.
• Willingness to participate and provide informed consent.

You may not qualify if:

• Participants will be excluded if they meet any of the following conditions:
• 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.
• History of intra-articular injection or knee surgery within the past 3 months.
• Questionnaire (PSEQ) with ≥ 20% of items missing or invalid.

Sponsors & Collaborators

• Khai Quang Nguyen, MD: lead

Study Sites (1)

Gia Dinh People's Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Khai Q Nguyen, MD, MSc

CONTACT

+84 704674558; khainq@bvndgiadinh.org.vn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head, Department of Rehabilitation

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: July 14, 2025
• Primary Completion: December 14, 2025
• Study Completion: December 31, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the primary results. Data will remain accessible for a period of 5 years following this initial release.
• Access Criteria: Qualified researchers affiliated with academic institutions or research organizations may access the data by submitting a data use request, including a brief proposal outlining research objectives, methodology, and intended outcomes. Data access is conditional upon signing a data-sharing agreement to ensure ethical use and data protection compliance.

Locations

VN (1)