Patellofemoral Pain SyndromeNCT05221060
Urdu Version of Kujala Questionnaire: A Reliability and Validity Study
An observational study of Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to interpret and make Kujala Questionnaire adaptable culturally into Urdu to investigate its validity and reliability in Pakistani population among anterior knee pain or patello femoral knee pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 15 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pakistani population with patello femoral pain syndrome and anterior knee pain.
Who may be able to join
- Both genders
- Ages range from 18-40 years
- They have clinically diagnosed with patello femoral pain syndrome (the diagnosis was established by a positive patellar grind test and pain on touch sensation, found in medial and lateral patellar facets)
- Participants who acquire 40 to 80 score on Kujala patellofemoral questionnaire before the treatment start
- Patients willing to participate.
Who cannot join
- Participants of the study who has gone through any treatment protocol curative measure for patellofemoral pain syndrome during the last 3 months.
- Any indication or medical record of lower extremity fracture or surgical procedure
- History of certain chronic disease e.g. Diabetes Mellitus
- Participants unable to understand Urdu Version of Kujala
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Reliability and Validity Study of Urdu Version of Kujala Questionnaire
The aim of this research is to interpret and make Kujala Questionnaire adaptable culturally into Urdu to investigate its validity and reliability in Pakistani population among anterior knee pain or patello femoral knee pain. Also check its correlation with 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form.
Read the detailed description
The original English version of Kujala Questionnaire will be translated and culturally adapted as per previous recommendation. In patients with anterior knee pain or patella femoral knee pain, Kujala Questionnaire-Urdu will be distributed among hundred participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Kujala, 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1 (re-testing), for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intraclass correlation coefficient. Urdu Version of Kujala was evaluated for content validity, construct validity, criterion validity and responsiveness.
- Keywords
- Kujala Questionnaire, patello femoral pain syndrome, anterior knee pain, validity, functional limitations, reliability
- Medical subject headings
- Patellofemoral Pain Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala Questionnaire
The Kujala Score is mainly used for the patients with anterior knee pain specially patients with patellofemoral pain syndrome that compromises of 13 questions asking about limping, supporting, walking , stairs descent and ascent movement, squat performance, running , jumping , sitting for a long time with flexed knee, pain intensity, swelling around joint, abnormally random knee cap movement that is also called as subluxation of patella ,weakness and atrophy of thigh muscles and lastly about the deficiencies that occurs during flexion movement. Kujala Score ranges from 0 to 100 .The lowest the score, the greater the severity of functional limitations and pain intensity and vice versa.
Measured: 1st day
36-Item Short Form Health Survey Questionnaire
36-Item Short Form Health Survey questionnaire that is self-administered and is largely used for overall health condition and assessment moreover widely used for research purpose. It contains 36 questions, including almost all basic 8 domains like; physical functioning, limitations due to the physical problems, bodily pain, general health perception, social functioning, vitality, limitations due to emotional problems, overall mental health and one more question about any health transition occurred in the last few days. Score ranges from up to 100, higher score means higher level of perfection of general health a low score means the increase level of functional deficit
Measured: 1st day
The Lysholm Score
The Lysholm Score is one of the most common questionnaire used for assessment of severity of pain and level of functional limitations in patients with patellofemoral pain syndrome. The point of concern are the ligaments Injury or mishap to ligament of the knee. Higher scores indicate a better outcome with fewer symptoms or disability.
Measured: 1st day
International Knee Documentation Committee Subjective Knee Evaluation Form
The International Knee Documentation Committee was formulated in 1987 as an International documentation system for knee deficits. Consisting 18 items out which 7 for symptoms, 1 for sports participation, 9 items for Activities of Daily Livings and lastly 1 for the current knee situation and function. Possible scoring ranges from 0 to 100, the greater the score the greater the functional capability, lower the score the increase chances of symptoms.
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 posted2 Feb 2022
- Study start30 May 2021
- Primary completion10 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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 director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221060
- Sponsor's protocol ID
- REC-FSD-0239
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 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
- Reliability and Validity Study of Urdu Version of Kujala Questionnaire
- ClinicalTrials.gov ID
- NCT05221060
- Acronym / sponsor ID
- REC-FSD-0239
- Keywords
- Kujala Questionnaire, patello femoral pain syndrome, anterior knee pain, validity, functional limitations, reliability
- 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 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 2 Feb 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 aim of this research is to interpret and make Kujala Questionnaire adaptable culturally into Urdu to investigate its validity and reliability in Pakistani population among anterior knee pain or patello femoral knee pain. Also check its correlation with 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form.
Detailed description
The original English version of Kujala Questionnaire will be translated and culturally adapted as per previous recommendation. In patients with anterior knee pain or patella femoral knee pain, Kujala Questionnaire-Urdu will be distributed among hundred participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Kujala, 36-Item Short Form Health Survey questionnaire, Lysholm Knee Scoring Scale and 2000 International Knee Documentation Committee Subjective Knee Evaluation Form will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1 (re-testing), for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intraclass correlation coefficient. Urdu Version of Kujala was 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 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pakistani population with patello femoral pain syndrome and anterior knee pain.
Key inclusion criteria (5 listed)
- Both genders
- Ages range from 18-40 years
- They have clinically diagnosed with patello femoral pain syndrome (the diagnosis was established by a positive patellar grind test and pain on touch sensation, found in medial and lateral patellar facets)
- Participants who acquire 40 to 80 score on Kujala patellofemoral questionnaire before the treatment start
- Patients willing to participate.
Key exclusion criteria (4 listed)
- Participants of the study who has gone through any treatment protocol curative measure for patellofemoral pain syndrome during the last 3 months.
- Any indication or medical record of lower extremity fracture or surgical procedure
- History of certain chronic disease e.g. Diabetes Mellitus
- Participants unable to understand Urdu Version of Kujala
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
Kujala Questionnaire
Time frame: 1st day
The Kujala Score is mainly used for the patients with anterior knee pain specially patients with patellofemoral pain syndrome that compromises of 13 questions asking about limping, supporting, walking , stairs descent and ascent movement, squat performance, running , jumping , sitting for a long time with flexed knee, pain intensity, swelling around joint, abnormally random knee cap movement that is also called as subluxation of patella ,weakness and atrophy of thigh muscles and lastly about the deficiencies that occurs during flexion movement. Kujala Score ranges from 0 to 100 .The lowest the score, the greater the severity of functional limitations and pain intensity and vice versa.
36-Item Short Form Health Survey Questionnaire
Time frame: 1st day
36-Item Short Form Health Survey questionnaire that is self-administered and is largely used for overall health condition and assessment moreover widely used for research purpose. It contains 36 questions, including almost all basic 8 domains like; physical functioning, limitations due to the physical problems, bodily pain, general health perception, social functioning, vitality, limitations due to emotional problems, overall mental health and one more question about any health transition occurred in the last few days. Score ranges from up to 100, higher score means higher level of perfection of general health a low score means the increase level of functional deficit
The Lysholm Score
Time frame: 1st day
The Lysholm Score is one of the most common questionnaire used for assessment of severity of pain and level of functional limitations in patients with patellofemoral pain syndrome. The point of concern are the ligaments Injury or mishap to ligament of the knee. Higher scores indicate a better outcome with fewer symptoms or disability.
International Knee Documentation Committee Subjective Knee Evaluation Form
Time frame: 1st day
The International Knee Documentation Committee was formulated in 1987 as an International documentation system for knee deficits. Consisting 18 items out which 7 for symptoms, 1 for sports participation, 9 items for Activities of Daily Livings and lastly 1 for the current knee situation and function. Possible scoring ranges from 0 to 100, the greater the score the greater the functional capability, lower the score the increase chances of symptoms.
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
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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 director
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 Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, 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 5 inclusion and 4 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?
Kujala Questionnaire (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 10 Mar 2022.