Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study

July 4, 2022 updated by: Riphah International University

Psychometric Properties and Cultural Adaptation of Urdu Version of Modified Oswestry Low Back Pain Scale Among Pakistani Low Back Pain Patients

The ultimate goal of this study is to interpret Modified Oswestry Low Back Pain Scale into Urdu and analyse its reliability and validity in the population of Pakistan lumber radiculopathy patients. Examine its correlation with Quebec back pain disability scale and the visual analogue scale, as well as the Roland-Morris disability questionnaire.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

As per preceding commendation, Modified Oswestry Low Back Pain Scale will be translated into Urdu language from its English version and adapted culturally in Pakistan. 100 individuals will be selected on the basis of convenience sampling with clinical characteristics. The patient will answer the questionnaire package that included the Urdu version Modified Oswestry Low Back Pain Scale, Quebec back pain disability scale, Roland-Morris disability questionnaire and Visual analogue scale on the same day, with a 30-minute delay between the first and second application. Observer-1 will be conducting a third assessment after 7 days for intra-observer evaluation. Statistical Package of Social Sciences Version 24 will be used to enter and evaluate the data. Internal consistency will be measured using the Cronbach alpha value. To evaluated test-retest reliability, an intraclass correlation coefficient will be employed. The Modified Oswestry Low Back Pain Scale will be evaluated for content validity, construct validity, criterion validity, and responsiveness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • ripah international university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pakistani Lumber radiculopathy population with low back pain.

Description

Inclusion Criteria:

  • Both genders, between the ages of 18 to 65,
  • Individuals who could read and speak Urdu as a first language
  • People who have been diagnosed with lumbar radiculopathy by a physician or neurosurgeon,
  • Low Back Pain in the lower extremities with or without radicular pain.

Exclusion Criteria:

  • Female patients who were pregnant
  • Patients with a mental health history, cancer, or neurological problems
  • Acute low back pain is a frequent disease (included recent thoraco-lumbar trauma),
  • Psychiatric and behavior issues, systemic disease (tumors and rheumatological diseases), and central or peripheral neurological problems
  • Patients who had recently had a cerebrovascular accident or a myocardial infarction were also ruled out.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Oswestry Low Back Pain Scale
Time Frame: 1st day
The Modified Oswestry Low Back Pain Scale includes one item for pain and nine items for daily living activities (personal care, lifting, walking, sitting, standing, sleeping, social life, and travel, employment/homemaking). There are a total of ten items in this scale. Each item is rated on a 6-point ordinal scale, with the best scenario being the best and the worst scenario being the worst.
1st day
Quebec back pain disability scale
Time Frame: 1st day
The Quebec back pain disability scale assesses the degree of functional impairment. The items reflect basic everyday tasks that people with back discomfort may find challenging to do. Bed/rest (items 1-3), sitting/standing (items 4-6), ambulation (items 7-9), mobility (items 10-12), bending/stooping (items 13-16), and handling of large/heavy things (items 17-20) are the six domains of activity impacted by back pain. There are a total of 20 items in this scale.
1st day
Roland-Morris disability questionnaire
Time Frame: 1st day
Roland-Morris disability questionnaire has a total of 24 components. Housework, sleeping, mobility, dressing, obtaining help, eating, irritability, and pain intensity are examples of daily physical activities and functions that may be impacted by Low Back Pain.
1st day
Visual analogue scale
Time Frame: 1st day
The Visual Analogue Scale was created to represent the concept of a fundamental continuity. A Visual Analogue Scale is typically a straight stripe measuring 100 mm long, with word descriptions for each end. The patient draws a line through the spot on the line which they believe best describes their present state. The Visual Analogue Scale score is calculated by calculating in millimeters as from the line's left side to the point marked by that of the patient. It usually ranges from "0" indicating "no pain" to the "10" indicating "worst pain".
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-FSD-00273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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