Musculoskeletal PainNCT05207540
Urdu Version Of Cornell Musculoskeletal Discomfort Questionnaire: Reliability And Validity Study
An observational study of Musculoskeletal Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to translate and adapt Cornell Musculoskeletal Discomfort Questionnaire cross-culturally into the Urdu language for the Pakistani population for investigating the reliability and validity of Cornell Musculoskeletal Discomfort Questionnaire in the Pakistani population and to study the correlation between… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 2 Feb 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Population suffering from musculoskeletal discomfort with a working routine of more than 6 hours both in sitting and standing position.
Who may be able to join
- Participants having an age limit of 18 to 55.
- Could read and understand the Urdu language.
- Both males and females working more than 6 hours in sitting and standing positions.
Who cannot join
- Having any fracture in any part of the body.
- Having any congenital or acquired disability that restricts them in their daily living.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: A Reliability and Validity Study of Urdu Version Of Cornell Musculoskeletal Discomfort Questionnaire
The study aims to translate and adapt Cornell Musculoskeletal Discomfort Questionnaire cross-culturally into the Urdu language for the Pakistani population for investigating the reliability and validity of Cornell Musculoskeletal Discomfort Questionnaire in the Pakistani population and to study the correlation between Nordic Musculoskeletal Questionnaire and the Visual Analogue Scale.
Read the detailed description
The English version of the Cornell Musculoskeletal Discomfort Questionnaire will be translated into Urdu and culturally adapted, as per a previous recommendation. The Cornell Musculoskeletal Discomfort Questionnaire will be given to one hundred and fifty workers of Masood Textile Mills, who would be chosen based on convenience sampling and inclusion and exclusion criteria. The inter-observer and intra-observer reliability of the Cornell Musculoskeletal Discomfort Questionnaire, Nordic Musculoskeletal Questionnaire, and Visual Analog Scale will be evaluated in this study. On the same day, the questionnaire will be filled out created two times. An Inter - observer assessment will be done with 2 hour break between distributions of questionnaires. The initial observer then will gather a third assessment over one-week period (intra-observer assessment). For data entry and analysis, Statistical Package of Social Sciences Version 24 will be utilized. Internal consistency will be checked using the Cronbach alpha value, and test retest reliability will be assessed using the Intraclass coefficient.
- Conditions
- Musculoskeletal Pain
- Keywords
- Cornell musculoskeletal discomfort questionnaire, factory workers, reliability, validity, Musculoskeletal discomfort
- Medical subject headings
- Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornell Musculoskeletal Discomfort Questionnaire
This questionnaire is used to access discomfort caused by Musculoskeletal disorders. It has 3 scales, frequency, severity and interference scale. It has 3 versions on the basis of the nature of work place and activity level i.e. Sedentary workers, standing workers and hand discomfort. Sedentary workers don't include the "foot" domain while the standing worker has this domain. The hand discomfort version is used to access only hand problems. Its interpretation can be done by multiplying all the scale score.
Measured: 1st day
Nordic Musculoskeletal Questionnaire
The Nordic Questionnaire is an internationally recognized tool for standardization research on Musculoskeletal symptom assessment. Its goal is to use an ergonomically approach to analyze Musculoskeletal problems. The very first component of this instrument includes questions on body parts that correlate to nine anatomical regions. The questions were structured in the following sequence: yearly and weekly prevalence; functional disability; and seeking medical treatment in the last year. This questionnaire can be used in an examination or by the individual who is now being assessed.
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 posted26 Jan 2022
- Study start30 May 2021
- Primary completion31 Jan 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- 150 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
- NCT05207540
- Sponsor's protocol ID
- REC-FSD-00299
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2022
- Last updated
- 10 Mar 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reliability and Validity Study of Urdu Version Of Cornell Musculoskeletal Discomfort Questionnaire
- ClinicalTrials.gov ID
- NCT05207540
- Acronym / sponsor ID
- REC-FSD-00299
- Conditions
- Musculoskeletal Pain
- Keywords
- Cornell musculoskeletal discomfort questionnaire, factory workers, reliability, validity, Musculoskeletal discomfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 26 Jan 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 study aims to translate and adapt Cornell Musculoskeletal Discomfort Questionnaire cross-culturally into the Urdu language for the Pakistani population for investigating the reliability and validity of Cornell Musculoskeletal Discomfort Questionnaire in the Pakistani population and to study the correlation between Nordic Musculoskeletal Questionnaire and the Visual Analogue Scale.
Detailed description
The English version of the Cornell Musculoskeletal Discomfort Questionnaire will be translated into Urdu and culturally adapted, as per a previous recommendation. The Cornell Musculoskeletal Discomfort Questionnaire will be given to one hundred and fifty workers of Masood Textile Mills, who would be chosen based on convenience sampling and inclusion and exclusion criteria. The inter-observer and intra-observer reliability of the Cornell Musculoskeletal Discomfort Questionnaire, Nordic Musculoskeletal Questionnaire, and Visual Analog Scale will be evaluated in this study. On the same day, the questionnaire will be filled out created two times. An Inter - observer assessment will be done with 2 hour break between distributions of questionnaires. The initial observer then will gather a third assessment over one-week period (intra-observer assessment). For data entry and analysis, Statistical Package of Social Sciences Version 24 will be utilized. Internal consistency will be checked using the Cronbach alpha value, and test retest reliability will be assessed using the Intraclass coefficient.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Population suffering from musculoskeletal discomfort with a working routine of more than 6 hours both in sitting and standing position.
Key inclusion criteria (3 listed)
- Participants having an age limit of 18 to 55.
- Could read and understand the Urdu language.
- Both males and females working more than 6 hours in sitting and standing positions.
Key exclusion criteria (2 listed)
- Having any fracture in any part of the body.
- Having any congenital or acquired disability that restricts them in their daily living.
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
Cornell Musculoskeletal Discomfort Questionnaire
Time frame: 1st day
This questionnaire is used to access discomfort caused by Musculoskeletal disorders. It has 3 scales, frequency, severity and interference scale. It has 3 versions on the basis of the nature of work place and activity level i.e. Sedentary workers, standing workers and hand discomfort. Sedentary workers don't include the "foot" domain while the standing worker has this domain. The hand discomfort version is used to access only hand problems. Its interpretation can be done by multiplying all the scale score.
Nordic Musculoskeletal Questionnaire
Time frame: 1st day
The Nordic Questionnaire is an internationally recognized tool for standardization research on Musculoskeletal symptom assessment. Its goal is to use an ergonomically approach to analyze Musculoskeletal problems. The very first component of this instrument includes questions on body parts that correlate to nine anatomical regions. The questions were structured in the following sequence: yearly and weekly prevalence; functional disability; and seeking medical treatment in the last year. This questionnaire can be used in an examination or by the individual who is now being assessed.
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 10 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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 Musculoskeletal 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 10 Mar 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?
Cornell Musculoskeletal Discomfort 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 10 Mar 2022.