NCT05221060

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

February 1, 2022

Last Update Submit

March 8, 2022

Conditions

Keywords

Kujala Questionnairepatello femoral pain syndromeanterior knee painvalidityfunctional limitationsreliability

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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.

    1st day

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pakistani population with patello femoral pain syndrome and anterior knee pain.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 2, 2022

Study Start

May 30, 2021

Primary Completion

February 10, 2022

Study Completion

February 15, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations