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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Sana Hanif, MSPT(SPT*) contact

Pakistan1 site, 1 recruiting
  • Ali Muhammad Memorial

    Multan, Punajb, 60000

    Abdul Wahab Majid, FCPS(Ortho), 03216336100

    Sana Hanif, MSPT

    Recruiting

Other trials in Pakistan

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.

  1. 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)
  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.

  1. First posted5 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

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)
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 20874835
  • Mokkink 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 20169472
  • Zaidi 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 28783980
  • Monticone 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 31559506
  • Farooq 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

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.

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