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

January 18, 2024 updated by: Ahmed ElMelhat, Cairo University

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

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:

  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.

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Ahmed ElMelhat [aelmelhat]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Is there an impact of tibial torsion on pain , disability and balance in women with patellofemoral pain syndrome ?
Time Frame: baseline
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
Is there an impact of navicular drop on pain , disability and balance in women with patellofemoral pain syndrome ?
Time Frame: baseline
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
Women were assessed using numerical pain rating scale (NPRS) for pain severity.
Time Frame: baseline
The NPRS has been extensively used to assess pain severity.The Arabic version of NPRS, has been culturally adapted and validated.
baseline
Women were assessed by Arabic version of Kujala for functional disability.
Time Frame: baseline
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
Women were assessed by Biodex Balance System for balance.
Time Frame: baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medhat EM [mmofty], Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Actual)

July 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PFPS and lower limb alignment

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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