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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03164824
Other study ID # MahidolU_Wunpen3
Secondary ID
Status Completed
Phase N/A
First received January 8, 2017
Last updated May 22, 2017
Start date April 2009
Est. completion date April 2011

Study information

Verified date May 2017
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria

The participants were eligible if they were:

1. aged 18 years or older

2. seeking physical therapy treatment for a complaint of back and/or neck pain

3. 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 20-25 minutes each time
Secondary questionnaire scores at the second visit questionnaire scores from the Thai FRI 5 minutes each time
Secondary Global Perceived Effect Scale (GPES) at the second visit 7-point GPES 3 minutes each time
Secondary 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 20-25 minutes each time
Secondary Global Perceived Effect Scale (GPES) at 2 weeks 7-point GPES 3 minutes each time
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