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Completed

NCT Number: NCT05842200

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

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.

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Ahmed ElMelhat [aelmelhat]

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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) .

  2. 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°.

  3. 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.

  4. 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.

  5. 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

  6. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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