- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164824
Thai Version of Functional Rating Index
Thai Version of the Functional Rating Index for Patients With Back and Neck Pain: Cross-cultural Adaptation and Psychometric Properties Testing
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
20-25 minutes each time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire scores at the second visit
Time Frame: 5 minutes each time
|
questionnaire scores from the Thai FRI
|
5 minutes each time
|
|
Global Perceived Effect Scale (GPES) at the second visit
Time Frame: 3 minutes each time
|
7-point GPES
|
3 minutes each time
|
|
questionnaire scores at 2 weeks
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: Thai FRI, Thai Neck Disability Index
|
20-25 minutes each time
|
|
Global Perceived Effect Scale (GPES) at 2 weeks
Time Frame: 3 minutes each time
|
7-point GPES
|
3 minutes each time
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wunpen Chansirinukor, PhD, Mahidol University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MahidolU_Wunpen3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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