- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842200
Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With PFPS.
Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With Patellofemoral Pain Syndrome: A Cross Sectional Study.
Purpose: The aim of this study is to figure out how does the selection of lower-extremity biomechanical variables presented by dynamic knee valgus, tibial torsion and navicular drop may influence pain, disability, and balance in women with patellofemoral pain syndrome.
Methods: Sixty-five women with patellofemoral pain syndrome will be evaluated for lower limb biomechanical variables.
Study Overview
Status
Detailed Description
Subjects:
Sixty five women who will be referred by an Orthopedist with patellofemoral pain syndrome diagnosis.
Inclusion criteria:
Women were enrolled in this study according to the following criteria:
- Female participants with patellofemoral pain syndrome.
- Age ranges between 18 and 38 years old.
- Bilateral or unilateral involvement.
- Minimum score (3 out of 10-point) numerical pain scale (NPR) .
- Orthopedic clinical confirmation revealing a history of anterior or retro-patellar knee pain aggravated by at least 2 of the following functional activities: 1. prolonged sitting, 2. stairs use, 3. squatting, 4. running, 5. kneeling, 6. hopping/jumping, and/or insidious onset of symptoms unrelated to any traumatic incident and persistent for at least 6 weeks.
Exclusion criteria:
A woman was excluded from the study if she has one or more of the following:
- History of patellar dislocation or subluxation.
- Osteoarthritis in the patellofemoral joint.
- Meniscal or other intraarticular pathologic conditions.
- cruciate or collateral ligament involvement.
- Lower limb surgery.
- Fracture, low back pain condition such as: spondylolisthesis and spondylosis.
- Neurological deficits.
- Traumatic injury or any abnormality in the lower extremity.
Methods: Sixty-five women with patellofemoral pain syndrome will be evaluated for dynamic knee valgus using Kinovea software program , tibial torsion using universal goniometer, and navicular drop using calliper.
Numerical pain rating scale (NPRS) will be used to measure pain severity. Arabic version of Kujala score will assess the functional disability in these patients.
Biodex Balance System will screen and will record the Medial-lateral stability index (MLSI), Anterior-posterior stability index (APSI) and an Overall stability index (OSI).
Assessments will be performed in a single session. Then correlation between these variables will be calculated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Ahmed ElMelhat [aelmelhat]
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Sixty-five women with patellofemoral pain syndrome, were included in this study. Individuals were selected from the outpatient clinics present in Cairo University and from private clinics in Cairo and Giza.
The age of selected women was ranging between 18 and 38 years old. They were able to follow instructions and understand the given commands
Description
Inclusion Criteria:
- Female participants with patellofemoral pain syndrome.
- Age ranges between 18 and 38 years old.
- Bilateral or unilateral involvement.
- Minimum score (3 out of 10-point) numerical pain scale (NPR)
- Orthopedic clinical confirmation revealing a history of anterior or retro-patellar knee pain aggravated by at least 2 of the following functional activities: 1. prolonged sitting, 2. stairs use, 3. squatting, 4. running, 5. kneeling, 6. hopping/jumping, and/or insidious onset of symptoms unrelated to any traumatic incident and persistent for at least 6 weeks.
Exclusion Criteria:
- History of patellar dislocation or subluxation.
- Osteoarthritis in the patellofemoral joint.
- Meniscal or other intraarticular pathologic conditions.
- Cruciate or collateral ligament involvement.
- Lower limb surgery.
- Fracture, low back pain condition such as: spondylolisthesis and spondylosis.
- Neurological deficits.
- Traumatic injury or any abnormality in the lower extremity
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Is there an impact of dynamic knee valgus on pain, disability and balance in women with patellofemoral pain?
Time Frame: baseline
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Dynamic knee valgus is a biomechanical variable that will be measured by Kinovea software program to measure 2D Frontal Plane Projection Angle (2D-FPPA) .
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baseline
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Is there an impact of tibial torsion on pain , disability and balance in women with patellofemoral pain syndrome ?
Time Frame: baseline
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Tibial Torsion will be measured with a universal goniometer with the participant prone on a low table, and with the tested knee bent at 90°.
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baseline
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Is there an impact of navicular drop on pain , disability and balance in women with patellofemoral pain syndrome ?
Time Frame: baseline
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Each participant will be asked to stand barefoot, with weight distributed evenly over each foot.
the distance between the navicular tuberosity and the floor will be measured, in millimetres, with a calliper.
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baseline
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Women were assessed using numerical pain rating scale (NPRS) for pain severity.
Time Frame: baseline
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The NPRS has been extensively used to assess pain severity.The Arabic version of NPRS, has been culturally adapted and validated.
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baseline
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Women were assessed by Arabic version of Kujala for functional disability.
Time Frame: baseline
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Kujala Scale, also known as anterior knee pain questionnaire (AKPS), is a self-report tool including 13 knee-specific questions. the Arabic version (AAKPS) has been tested for its validity and reliability in Arabian patients
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baseline
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Women were assessed by Biodex Balance System for balance.
Time Frame: baseline
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Biodex Balance System will screen and will record the Medial-lateral stability index (MLSI), Anterior-posterior stability index (APSI) and an Overall stability index (OSI).
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medhat EM [mmofty], Cairo University
Publications and helpful links
Helpful Links
- Is spinopelvic sagittal alignment correlated with pain level, functional disability and frontal plane projection angle in women with patellofemoral pain syndrome? A cross-sectional study
- Comparison of selected lower limb biomechanical variables between university of ibadan sportsmen with and without patellofemoral pain syndrome
- Evaluation of postural balance using the biodex balance system in subjects with and without low back pain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFPS and lower limb alignment
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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