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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04831749
Other study ID # REC/00932 Sana Hanif
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 30, 2021

Study information

Verified date April 2021
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ali Muhammad Memorial Multan Punajb

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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. 6 months
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