Low Back PainNCT04831749
Translation of Quebec Back Pain Disability Scale Into Local Languages of Pakistan.
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the present study is to translate the Quebec Back Pain Disability Scale into Pashto, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 800 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 30 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To meet inclusion criteria participants diagnosed with low back pain, clinically stable, and able to read the local language version of QBPDS. Then patient response will be checked on the translated versions
Who may be able to join
- Patients both male and female having age group equal or >18,
- should be able to read the questionnaire that is in their native language(Punjabi, Sindhi, Balochi and Pashto) and
- 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, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
- Any issues in understanding or expressing the native language (Punjabi, Pashto, Balochi or Sindhi) will be excluded.
Trial locations and contacts
1 site in 1 country.
Sana Hanif, MSPT(SPT*) contact
Pakistan1 site, 1 recruiting
- Recruiting
Ali Muhammad Memorial
Multan, Punajb, 60000
Abdul Wahab Majid, FCPS(Ortho), 03216336100
Sana Hanif, MSPT
About this study
Official title: Cross-cultural Translation and Validation of the Quebec Back Pain Disability Scale Into Local Languages of Pakistan.
The aim of the present study is to translate the Quebec Back Pain Disability Scale into Pashto, 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-culture adaptation.
Read the detailed description
The Quebec Back Pain Disability Scale is a first-hand measure of functional disability for patients with back pain. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its major aim is to be a responsive measure of functional disability in back pain. Quebec back pain disability Questionnaire has unique strong characteristics that are quite feasibly used and have good identification properties regarding Low Back Pain. There is extensive usage, applicability, and validity of QBPDS in research and clinical practice. Along with these factors the capability of the QBPDS to identify significant fluctuations in patient's condition, makes its use evidently advocated.
Quebec Pain disability scale, originally a French scale has been translated and validated into a few languages before. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and to study effects of treatments in low back pain patients. Along with helping in appraisals of outcomes amongst various populations. So, to gather the best outcomes of this questionnaire in Pakistan region it is imperative to translate it into Pashto, Punjabi, Sindhi and Balochi hence the local languages.
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Quebec Back Pain Disability Scale, Tool Translation
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-Cultural Translation of Quebec Back Pain Disability Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi)
The Quebec Back Pain Disability Scale is a first-hand measure of functional disability for patients with back pain. The scale has 20 items, representing six empirically derived categories of activities affected by back pain. It is an self-administered tool targeted on the population with Low back pain. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its translation is to be done in local languages of Pakistan through a rigorous and approved process
Measured: 6 months
Secondary outcomes (1)
reliability and validity of translated versions
To determine reliability and validity of cross-culturally adapted and the translated QBPDS versions in patients with low back pain of respective languages۔ Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient and validity is how accurate the results are. Thus these both are to measured through various parameters to validate the translated versions as appropriate and applicable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 800 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
- NCT04831749
- Sponsor's protocol ID
- REC/00932 Sana Hanif
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
PubMed 20874835Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.
PubMed 20169472Zaidi S, Verma S, Moiz JA, Hussain ME. Transcultural adaptation and validation of Hindi version of Quebec Back Pain Disability Scale. Disabil Rehabil. 2018 Dec;40(24):2938-2945. doi: 10.1080/09638288.2017.1362596. Epub 2017 Aug 7.
PubMed 28783980Monticone M, Frigau L, Mola F, Rocca B, Franchignoni F, Simone Vullo S, Foti C, Chiarotto A. The Italian version of the Quebec Back Pain Disability Scale: cross-cultural adaptation, reliability and validity in patients with chronic low back pain. Eur Spine J. 2020 Mar;29(3):530-539. doi: 10.1007/s00586-019-06153-4. Epub 2019 Sep 26.
PubMed 31559506Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5.
PubMed 28388888
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Translation and Validation of the Quebec Back Pain Disability Scale Into Local Languages of Pakistan.
- ClinicalTrials.gov ID
- NCT04831749
- Acronym / sponsor ID
- REC/00932 Sana Hanif
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Quebec Back Pain Disability Scale, Tool Translation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 5 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.
The aim of the present study is to translate the Quebec Back Pain Disability Scale into Pashto, 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-culture adaptation.
Detailed description
The Quebec Back Pain Disability Scale is a first-hand measure of functional disability for patients with back pain. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its major aim is to be a responsive measure of functional disability in back pain. Quebec back pain disability Questionnaire has unique strong characteristics that are quite feasibly used and have good identification properties regarding Low Back Pain. There is extensive usage, applicability, and validity of QBPDS in research and clinical practice. Along with these factors the capability of the QBPDS to identify significant fluctuations in patient's condition, makes its use evidently advocated.
Quebec Pain disability scale, originally a French scale has been translated and validated into a few languages before. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and to study effects of treatments in low back pain patients. Along with helping in appraisals of outcomes amongst various populations. So, to gather the best outcomes of this questionnaire in Pakistan region it is imperative to translate it into Pashto, Punjabi, Sindhi and Balochi hence the local languages.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To meet inclusion criteria participants diagnosed with low back pain, clinically stable, and able to read the local language version of QBPDS. Then patient response will be checked on the translated versions
Key inclusion criteria (3 listed)
- Patients both male and female having age group equal or >18,
- should be able to read the questionnaire that is in their native language(Punjabi, Sindhi, Balochi and Pashto) and
- diagnosed with nonspecific low back pain for more than 3 months.
Key exclusion criteria (3 listed)
- Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently,
- any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
- Any issues in understanding or expressing the native language (Punjabi, Pashto, Balochi or Sindhi) 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
Cross-Cultural Translation of Quebec Back Pain Disability Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi)
Time frame: 6 months
The Quebec Back Pain Disability Scale is a first-hand measure of functional disability for patients with back pain. The scale has 20 items, representing six empirically derived categories of activities affected by back pain. It is an self-administered tool targeted on the population with Low back pain. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its translation is to be done in local languages of Pakistan through a rigorous and approved process
1 secondary outcome
reliability and validity of translated versions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Background: PubMed 20874835Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
- Background: PubMed 20169472Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.
- Background: PubMed 28783980Zaidi S, Verma S, Moiz JA, Hussain ME. Transcultural adaptation and validation of Hindi version of Quebec Back Pain Disability Scale. Disabil Rehabil. 2018 Dec;40(24):2938-2945. doi: 10.1080/09638288.2017.1362596. Epub 2017 Aug 7.
- Background: PubMed 31559506Monticone M, Frigau L, Mola F, Rocca B, Franchignoni F, Simone Vullo S, Foti C, Chiarotto A. The Italian version of the Quebec Back Pain Disability Scale: cross-cultural adaptation, reliability and validity in patients with chronic low back pain. Eur Spine J. 2020 Mar;29(3):530-539. doi: 10.1007/s00586-019-06153-4. Epub 2019 Sep 26.
- Background: PubMed 28388888Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5.
- 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.
Sana Hanif, MSPT(SPT*) contact
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 3 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 5 Apr 2021. 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?
Cross-Cultural Translation of Quebec Back Pain Disability Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi) (time frame: 6 months). 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 NCT04831749, which also lists 5 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 5 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.