Knee Osteoarthritis (Knee OA)NCT07130630
Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis
An observational study of Knee Osteoarthritis (Knee OA), run by Khai Quang Nguyen, MD at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)
- How many people
- 173 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Gia Dinh People's Hospital
Ho Chi Minh City, Ho Chi Minh, 700000
Hai H Nguyen, MD, PhD, +84 908247359, hainh@bvndgiadinh.org.vn
About this study
Official title: Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis
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.
Read more
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)
- Being tested
- Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start14 Jul 2025
- Primary completion14 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khai Quang Nguyen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khai Quang Nguyen, MD, Gia Dinh People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130630
- Sponsor's protocol ID
- 113/NDGĐ- HĐĐĐ
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results of this study will be shared with other researchers upon reasonable request. The data will be de-identified to protect participant privacy and used solely for academic and non-commercial research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07130630
- Acronym / sponsor ID
- 113/NDGĐ- HĐĐĐ
- Conditions
- Knee Osteoarthritis (Knee OA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Khai Quang Nguyen, MDUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 14 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Knee Osteoarthritis | – | Other: Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age ≥ 50 years.
- Diagnosis of knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology (ACR), confirmed by:
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)Participants completed the Vietnamese version of the Pain Self-Efficacy Questionnaire (PSEQ) to assess self-efficacy beliefs related to pain management. | Other | Patients with Knee Osteoarthritis |
Primary outcome
Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ)
Time frame: Baseline and follow-up at Day 3 for test-retest group
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.
1 secondary outcome
Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score
Time frame: At baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results of this study will be shared with other researchers upon reasonable request. The data will be de-identified to protect participant privacy and used solely for academic and non-commercial research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis (Knee OA), run by Khai Quang Nguyen, MD at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khai Q Nguyen, MD, MSc (+84 704674558, khainq@bvndgiadinh.org.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) (time frame: Baseline and follow-up at Day 3 for test-retest group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.