NCT03164824

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

January 8, 2017

Last Update Submit

May 22, 2017

Conditions

Keywords

QuestionnaireFunctional Rating IndexCross-cultural adaptationPsychometric properties testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • questionnaire scores at the second visit

    5 minutes each time

  • Global Perceived Effect Scale (GPES) at the second visit

    3 minutes each time

  • questionnaire scores at 2 weeks

    20-25 minutes each time

  • Global Perceived Effect Scale (GPES) at 2 weeks

    3 minutes each time

Interventions

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From physical therapy department in 9 settings in Thailand

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Wunpen Chansirinukor, PhD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2017

First Posted

May 24, 2017

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share