Low Back PainNCT04852952
Cross-cultural Translation of Oswestry Disability Index (ODI) Into Local Languages of Pakistan
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- How many people
- 576 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2021to 27 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 1000
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Islamabad, Fedral, 44000
Imran Amjad, PhD, +92 332 4390125, imran.amjad@riphah.edu.pk
Sidra Naqvi, MSNMPT*
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability Index translated versions
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.
Measured: 1 year
Secondary outcomes (2)
Reliability of translated versions of Oswestry disability Index
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.
Measured: 1 year
Validity of translated versions of Oswestry disability Index
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 May 2021
- Primary completion23 Dec 2022 (estimated)
- Study completion27 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852952
- Sponsor's protocol ID
- REC/00931 Qandeel
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3.
PubMed 23380824Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
PubMed 15129077Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7.
PubMed 16778675
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Translation of Oswestry Disability Index (ODI) Into Local Languages of Pakistan
- ClinicalTrials.gov ID
- NCT04852952
- Acronym / sponsor ID
- REC/00931 Qandeel
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 27 Dec 2022 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1000
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Reliability of translated versions of Oswestry disability Index
Time frame: 1 year
Validity of translated versions of Oswestry disability Index
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 23380824Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3.
- Background: PubMed 15129077Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
- Background: PubMed 16778675Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7.
- Development of Brazilian version of ODI scaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability Index translated versions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852952, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.