Clinical trial NCT05842200: Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With PFPS.
Official title: Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With Patellofemoral Pain Syndrome: A Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellofemoral Pain Syndrome
Patellofemoral Malalignment Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Is there an impact of dynamic knee valgus on pain, disability and balance in women with patellofemoral pain?
timeFrame: baseline
measure: Is there an impact of tibial torsion on pain , disability and balance in women with patellofemoral pain syndrome ?
timeFrame: baseline
measure: Is there an impact of navicular drop on pain , disability and balance in women with patellofemoral pain syndrome ?
timeFrame: baseline
measure: Women were assessed using numerical pain rating scale (NPRS) for pain severity.
timeFrame: baseline
measure: Women were assessed by Arabic version of Kujala for functional disability.
timeFrame: baseline
measure: Women were assessed by Biodex Balance System for balance.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed ElMelhat [aelmelhat]
Study officials:
affiliation: Cairo University
name: Medhat EM [mmofty]
role: STUDY_DIRECTOR
References: