NCT07130630 Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis
| NCT ID | NCT07130630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Khai Quang Nguyen, MD |
| Condition | Knee Osteoarthritis (Knee OA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 173 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2025-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 173 participants in total. It began in 2025-07-14 with a primary completion date of 2025-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Participants will be eligible for inclusion if they meet all of the following conditions: * Age ≥ 50 years. * Diagnosis of knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology (ACR), confirmed by: 1. application of ACR criteria by the investigator at the time of enrollment; or 2. 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. Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07130630 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Knee Osteoarthritis (Knee OA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07130630 currently recruiting?
Yes, NCT07130630 is actively recruiting participants. Contact the research team at khainq@bvndgiadinh.org.vn for enrollment information.
Where is the NCT07130630 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT07130630 clinical trial?
NCT07130630 is sponsored by Khai Quang Nguyen, MD. The trial plans to enroll 173 participants.