Cross-cultural Translation of Oswestry Disability Index (ODI) Into Local Languages of Pakistan

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04852952
Collaborator
(none)
576
1
19.3
29.9

Study Details

Study Description

Brief Summary

Descriptive analytical study to translate the Oswestry Disability Index into local languages of Pakistan that are, Pashto, Urdu, Punjabi, Sindhi, and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from low back pain. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-cultural adaptation.

Condition or disease: Musculoskeletal disorders and disabilities caused by Low back pain, Non-probability Purposive Sampling would be used. The study will be conducted in relevant areas of Pakistan.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    As in the original study the main purpose of the Oswestry Disability Index is explained as to assess pain-related disability in persons with low back pain (LBP). The target population for the Oswestry are 3: acute, subacute, and chronic back pain client groups; with various conservative, surgical, and behavioural intervention groups.

    The Oswestry Disability Index is one of the principal condition-specific outcome measures used for the investigation of low back musculoskeletal disorders. It is a self-administered questionnaire and consists of ten sections that are designed to assess the limitations of various daily life activities.

    Each section is scored on a 0-5 scale, 5 is for maximum disability. The index is calculated by dividing the total score by the total possible score, which is multiplied by 100 and expressed as a percentage. Thus, for every unanswered question, the denominator is reduced by 5. If a patient marks two or more statements in a question, the highest-scoring statement is recorded as a true indication of disability. The questionnaire takes 3.5-5 min to complete andapproximately1 min to score.

    At present worldwide there are a lot of health care workers who are using the Oswestry Disability Index for low back pain assessment and this scale is also providing good measurement but this scale is in the English language and there are a lot of people here in Pakistan who don't understand English. Pakistan is a country with different languages and cultures. The most commonly spoken and understood languages in Pakistan are Urdu the national language of Pakistan, Pashto, Punjabi, Sindhi, and Balochi. Therefore it is highly needed to translate this questioner into different languages so that the patient would be able to answer them easily according to their understanding. The validity and reliability of the translated versions will also be checked.

    The translation and cultural adaptation processes would start after obtaining approval from the developer of the original Oswestry Disability Index scale. This would be done according to WHO guidelines. Translation will be done by symmetrical category. The purpose will be to gain uniformity in the translation of tool in both the Target language and Source language. This will involve 5 steps. (Forward translation, synthesis 1, Back translation, synthesis 2 and pilot testing.) Phase 2 would be done according to the standard guidelines in which psychometric properties will be measured.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    576 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cross-cultural Translation of Oswestry Disability Index (ODI) Into Local Languages of Pakistan
    Actual Study Start Date :
    May 20, 2021
    Anticipated Primary Completion Date :
    Dec 23, 2022
    Anticipated Study Completion Date :
    Dec 27, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Oswestry disability Index translated versions [1 year]

      Self report versions. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

    Secondary Outcome Measures

    1. Reliability of translated versions of Oswestry disability Index [1 year]

      To determine the reliability of cross-culturally adapted and the Oswestry disability Index translated versions in patients with the back pain of respective languages۔ Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two intervals between different visits of the patient. Thus this will be measured through test re-test reliability.

    2. Validity of translated versions of Oswestry disability Index [1 year]

      To determine the validity of cross-culturally adapted and the translated Oswestry disability Index versions in patients with the back pain of respective languages۔ Validity is how accurate the results are. Thus this will be measured through various parameters to validate the translated versions as appropriate and applicable.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient both female and male having age group equal or >18.

    • Patients should be capable to complete the questionnaire without any help.

    • Diagnosed with nonspecific low back pain for more than 3 months.

    Exclusion Criteria:
    • Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumour, spinal surgery, or any other rheumatological disease will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riphah International University Islamabad Fedral Pakistan 44000

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Imran Amjad, PhD, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT04852952
    Other Study ID Numbers:
    • REC/00931 Qandeel
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022