Lumbar RadiculopathyNCT05449288
Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
An observational study of Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Mar 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pakistani Lumber radiculopathy population with low back pain.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Radiculopathy
- Keywords
- Modified Oswestry Low Back Pain Scale, Urdu Version, Reliability, Validity, Lumbar Radiculopathy, Low Back Pain
- Medical subject headings
- Radiculopathy, Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
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".
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 May 2021
- Primary completion10 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449288
- Sponsor's protocol ID
- REC-FSD-00273
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties and Cultural Adaptation of Urdu Version of Modified Oswestry Low Back Pain Scale Among Pakistani Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05449288
- Acronym / sponsor ID
- REC-FSD-00273
- Conditions
- Lumbar Radiculopathy
- Keywords
- Modified Oswestry Low Back Pain Scale, Urdu Version, Reliability, Validity, Lumbar Radiculopathy, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pakistani Lumber radiculopathy population with low back pain.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Radiculopathy, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oswestry Low Back Pain Scale (time frame: 1st day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2022.