Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With PFPS.

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With Patellofemoral Pain Syndrome: A Cross Sectional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842200
• Other study ID #: PFPS and lower limb alignment
• Status: Completed
• Start date: June 10, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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: 1. Female participants with patellofemoral pain syndrome. 2. Age ranges between 18 and 38 years old. 3. Bilateral or unilateral involvement. 4. Minimum score (3 out of 10-point) numerical pain scale (NPR) . 5. 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: 1. History of patellar dislocation or subluxation. 2. Osteoarthritis in the patellofemoral joint. 3. Meniscal or other intraarticular pathologic conditions. 4. cruciate or collateral ligament involvement. 5. Lower limb surgery. 6. Fracture, low back pain condition such as: spondylolisthesis and spondylosis. 7. Neurological deficits. 8. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Syndrome

Locations

Country	Name	City	State
Egypt	Ahmed ElMelhat [aelmelhat]	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is there an impact of dynamic knee valgus on pain, disability and balance in women with patellofemoral pain?	Dynamic knee valgus is a biomechanical variable that will be measured by Kinovea software program to measure 2D Frontal Plane Projection Angle (2D-FPPA) .	baseline
Primary	Is there an impact of tibial torsion on pain , disability and balance in women with patellofemoral pain syndrome ?	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°.	baseline
Primary	Is there an impact of navicular drop on pain , disability and balance in women with patellofemoral pain syndrome ?	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.	baseline
Primary	Women were assessed using numerical pain rating scale (NPRS) for pain severity.	The NPRS has been extensively used to assess pain severity.The Arabic version of NPRS, has been culturally adapted and validated.	baseline
Primary	Women were assessed by Arabic version of Kujala for functional disability.	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	baseline
Primary	Women were assessed by Biodex Balance System for balance.	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).	baseline

External Links

•   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
•   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