QuestionnaireNCT03164824
Thai Version of Functional Rating Index
An observational study of Questionnaire, run by Mahidol University.
Trial summary
The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating Index (FRI), to test psychometric properties of the translated questionnaire and to examine head-to-head comparisons with other questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Questionnaire
- What is being tested?
- questionnaire
- How many people
- 247 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From physical therapy department in 9 settings in Thailand
Who may be able to join
- The participants were eligible if they were:
- aged 18 years or older
- seeking physical therapy treatment for a complaint of back and/or neck pain
- able to understand, read, speak and write Thai
Who cannot join
- The participants who were not willing to take part in the study, unable to understand, read, speak and write Thai were excluded from this study.
About this study
Official title: Thai Version of the Functional Rating Index for Patients With Back and Neck Pain: Cross-cultural Adaptation and Psychometric Properties Testing
The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating Index (FRI), to test psychometric properties of the translated questionnaire and to examine head-to-head comparisons with other questionnaires.
Read the detailed description
This study comprised 2 major stages: 1) Cross-cultural adaptation and 2) psychometric properties testing.
Cross-cultural adaptation stage:
The FRI was cross-culturally adapted to Thai following the well-accepted guideline for the process of cross-cultural adaptation of self-report measure.
Psychometric properties testing stage:
The patients with back or neck pain completed the questionnaires at the first visit, the second visit and at 2-week (or at discharge or when reporting 80% improvement from the first visit).
- Conditions
- Questionnaire
- Being tested
- questionnaire
- Keywords
- Questionnaire, Functional Rating Index, Cross-cultural adaptation, Psychometric properties testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Cross-cultural adaptation stage:
The FRI was cross-culturally adapted to Thai (called the Thai FRI) and the pre-final version of the Thai FRI was administered to patients.
Psychometric properties testing stage:
The questionnaires were administered 3 times: the first visit, the second visit and at 2 weeks.
At the first visit: the patients with back pain completed the Thai FRI , Thai Roland-Morris Disability (Thai RM), Thai modified Oswestry Low Back Pain Disability (Thai modified ODQ), Thai multi-level Roland-Morris Disability (Thai multi-level RM). The patients with neck pain completed the Thai FRI and Thai Neck Disability Index.
At the second visit: all patients completed the Thai FRI and Global Perceived Effect Scale (GPES).
At 2 weeks: the patients completed the same questionnaires as the first visit. All patients and their treating physical therapists completed the GPES.
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire scores at the first visit
Back pain group: questionnaire scores from the Thai FRI, Thai RM, Thai modified ODQ, Thai multi-level RM; Neck pain group: questionnaire scores from the Thai FRI and Thai Neck Disability Index
Measured: 20-25 minutes each time
Secondary outcomes (4)
questionnaire scores at the second visit
questionnaire scores from the Thai FRI
Measured: 5 minutes each time
Global Perceived Effect Scale (GPES) at the second visit
7-point GPES
Measured: 3 minutes each time
questionnaire scores at 2 weeks
Back pain group: questionnaire scores from the Thai FRI, Thai RM, Thai modified ODQ, Thai multi-level RM; Neck pain group: Thai FRI, Thai Neck Disability Index
Measured: 20-25 minutes each time
Global Perceived Effect Scale (GPES) at 2 weeks
7-point GPES
Measured: 3 minutes each time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuestionnaireStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wunpen Chansirinukor, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164824
- Sponsor's protocol ID
- MahidolU_Wunpen3
- Status last verified
- May 2017
- First submitted
- 8 Jan 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thai Version of the Functional Rating Index for Patients With Back and Neck Pain: Cross-cultural Adaptation and Psychometric Properties Testing
- ClinicalTrials.gov ID
- NCT03164824
- Acronym / sponsor ID
- MahidolU_Wunpen3
- Conditions
- Questionnaire
- Keywords
- Questionnaire, Functional Rating Index, Cross-cultural adaptation, Psychometric properties testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 May 2017 (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.
The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating Index (FRI), to test psychometric properties of the translated questionnaire and to examine head-to-head comparisons with other questionnaires.
Detailed description
This study comprised 2 major stages: 1) Cross-cultural adaptation and 2) psychometric properties testing.
Cross-cultural adaptation stage:
The FRI was cross-culturally adapted to Thai following the well-accepted guideline for the process of cross-cultural adaptation of self-report measure.
Psychometric properties testing stage:
The patients with back or neck pain completed the questionnaires at the first visit, the second visit and at 2-week (or at discharge or when reporting 80% improvement from the first visit).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From physical therapy department in 9 settings in Thailand
Key inclusion criteria (4 listed)
- aged 18 years or older
- seeking physical therapy treatment for a complaint of back and/or neck pain
- able to understand, read, speak and write Thai
Key exclusion criteria (1 listed)
- The participants who were not willing to take part in the study, unable to understand, read, speak and write Thai were excluded from this study.
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 |
|---|---|---|
| questionnaireCross-cultural adaptation stage: The FRI was cross-culturally adapted to Thai (called the Thai FRI) and the pre-final version of the Thai FRI was administered to patients. Psychometric properties testing stage: The questionnaires were administered 3 times: the first visit, the second visit and at 2 weeks. At the first visit: the patients with back pain completed the Thai FRI , Thai Roland-Morris Disability (Thai RM), Thai modified Oswestry Low Back Pain Disability (Thai modified ODQ), Thai multi-level Roland-Morris Disability (Thai multi-level RM). The patients with neck pain completed the Thai FRI and Thai Neck Disability Index. At the second visit: all patients completed the Thai FRI and Global Perceived Effect Scale (GPES). At 2 weeks: the patients completed the same questionnaires as the first visit. All patients and their treating physical therapists completed the GPES. | Other | – |
Primary outcome
questionnaire scores at the first visit
Time frame: 20-25 minutes each time
Back pain group: questionnaire scores from the Thai FRI, Thai RM, Thai modified ODQ, Thai multi-level RM; Neck pain group: questionnaire scores from the Thai FRI and Thai Neck Disability Index
4 secondary outcomes
questionnaire scores at the second visit
Time frame: 5 minutes each time
Global Perceived Effect Scale (GPES) at the second visit
Time frame: 3 minutes each time
questionnaire scores at 2 weeks
Time frame: 20-25 minutes each time
Global Perceived Effect Scale (GPES) at 2 weeks
Time frame: 3 minutes each time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Wunpen Chansirinukor, PhD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Questionnaire, run by Mahidol University.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire scores at the first visit (time frame: 20-25 minutes each time). 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 24 May 2017.