Low Back PainNCT05429931
Reliability and Validity of Urdu Version of Ronald Morris Disability Questionnaire in Patients With Low Back Pain
An observational study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pakistani population with Chronic Low back pain.
Who may be able to join
- Average Age of patient 48 years.
- Patient with chronic low back pain have at least 3 month duration .
- Patient with mechanical Low Back Pain
Who cannot join
- Patient with non - mechanical Low Back Pain
- Patient have neurological deficits .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Urdu Version of The Ronald Morris Disability Questionnaire in Patients With Low Back Pain : Assessing Its Psychometric Properties and Cultural Adaptation.
Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale.
Read the detailed description
The Ronald Morris Disability Questionnaire will be translated into Urdu and culturally adapted for people with low back pain. Ronald Morris Disability Questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. Method of sampling based on pre-determined inclusion and exclusion criteria. To examine intra-observer reliability of the final Ronald Morris Disability Questionnaire, two observers will fill out Oswestry Disability Index and Visual Analogue Scale questionnaires on the same day to test inter-observer evaluation. After 30 minutes of the initial treatment, the second application will be applied. The first observer will do the third assessment after seven days. Statistical Package of Social Sciences Version 24 will be used to enter and analyse data. The alpha value of Cronbach's alpha will be examined.
- Conditions
- Low Back Pain
- Keywords
- Ronald Morris Disability Questionnaire, Urdu Version, Reliability, Validity, Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris Disability Questionnaire
Roland-Morris Disability Questionnaire consist of 24 point according to low back pain population in which patients tell about all Daily Activity . patients scores the questionnaire among 24 points. Roland-Morris Disability Questionnaire is the highest result possible '24'.
Measured: 1st day
Oswestry Disability Index
Oswestry Disability Index is an instrument or scale use for the evaluation of pain . this scale is especially designed for low back pain.
Oswestry Disability Index consist of 10 section or 9 section divide the point out of 50 or 45 . if one section is not score then divided by 45 and get score of patient.after get score multiply with 100 to get percentage. 0 to 21% indicate minimal disability , 21 to 40 indicate moderate disability and 41 to 60 indicate severe disability. 61 to 80 indicate crippled.
Measured: 1st day
Visual Analogue Scale
Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "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 posted23 Jun 2022
- Study start30 May 2021
- Primary completion10 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- NCT05429931
- Sponsor's protocol ID
- REC/FSD/0296
- Status last verified
- May 2024
- First submitted
- 20 Jun 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Version of The Ronald Morris Disability Questionnaire in Patients With Low Back Pain : Assessing Its Psychometric Properties and Cultural Adaptation.
- ClinicalTrials.gov ID
- NCT05429931
- Acronym / sponsor ID
- REC/FSD/0296
- Conditions
- Low Back Pain
- Keywords
- Ronald Morris Disability Questionnaire, Urdu Version, Reliability, Validity, 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 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 23 Jun 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.
Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale.
Detailed description
The Ronald Morris Disability Questionnaire will be translated into Urdu and culturally adapted for people with low back pain. Ronald Morris Disability Questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. Method of sampling based on pre-determined inclusion and exclusion criteria. To examine intra-observer reliability of the final Ronald Morris Disability Questionnaire, two observers will fill out Oswestry Disability Index and Visual Analogue Scale questionnaires on the same day to test inter-observer evaluation. After 30 minutes of the initial treatment, the second application will be applied. The first observer will do the third assessment after seven days. Statistical Package of Social Sciences Version 24 will be used to enter and analyse data. The alpha value of Cronbach's alpha will be examined.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pakistani population with Chronic Low back pain.
Key inclusion criteria (3 listed)
- Average Age of patient 48 years.
- Patient with chronic low back pain have at least 3 month duration .
- Patient with mechanical Low Back Pain
Key exclusion criteria (2 listed)
- Patient with non - mechanical Low Back Pain
- Patient have neurological deficits .
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
Roland-Morris Disability Questionnaire
Time frame: 1st day
Roland-Morris Disability Questionnaire consist of 24 point according to low back pain population in which patients tell about all Daily Activity . patients scores the questionnaire among 24 points. Roland-Morris Disability Questionnaire is the highest result possible '24'.
Oswestry Disability Index
Time frame: 1st day
Oswestry Disability Index is an instrument or scale use for the evaluation of pain . this scale is especially designed for low back pain. Oswestry Disability Index consist of 10 section or 9 section divide the point out of 50 or 45 . if one section is not score then divided by 45 and get score of patient.after get score multiply with 100 to get percentage. 0 to 21% indicate minimal disability , 21 to 40 indicate moderate disability and 41 to 60 indicate severe disability. 61 to 80 indicate crippled.
Visual Analogue Scale
Time frame: 1st day
Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "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 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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 Low Back Pain, 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 3 inclusion and 2 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 7 May 2024. 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?
Roland-Morris Disability Questionnaire (time frame: 1st day). The study lists 3 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 7 May 2024.