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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04852952
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : May 28, 2021
Information provided by (Responsible Party):
Riphah International University

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
Low Back Pain

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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 23, 2021
Estimated Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. Oswestry disability Index translated versions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04852952

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Contact: Imran Amjad, PhD 03324390125
Contact: Qandeel hamidullah Khan, MS-SPT 03335735947

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Riphah International University Recruiting
Islamabad, Fedral, Pakistan, 44000
Contact: Imran Amjad, PhD    +92 332 4390125   
Principal Investigator: Sidra Naqvi, MSNMPT*         
Sponsors and Collaborators
Riphah International University
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Principal Investigator: Imran Amjad, PhD Riphah International University
Additional Information:
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Responsible Party: Riphah International University Identifier: NCT04852952    
Other Study ID Numbers: REC/00931 Qandeel
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Neurologic Manifestations