- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05449288
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
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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
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
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 30, 2021
Primary Completion (ACTUAL)
March 10, 2022
Study Completion (ACTUAL)
March 12, 2022
Study Registration Dates
First Submitted
July 4, 2022
First Submitted That Met QC Criteria
July 4, 2022
First Posted (ACTUAL)
July 8, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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