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

Lumbar Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449288
• Other study ID #: REC-FSD-00273
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: March 12, 2022

Study information

• Verified date: July 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 12, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lumbar Radiculopathy
• Radiculopathy

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Oswestry Low Back Pain Scale	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
Primary	Quebec back pain disability scale	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
Primary	Roland-Morris disability questionnaire	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
Primary	Visual analogue scale	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