Patellofemoral Pain SyndromeNCT05842200
Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With PFPS.
An observational study of Patellofemoral Pain Syndrome and Patellofemoral Malalignment Syndrome, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Patellofemoral Malalignment Syndrome
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 20 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Patellofemoral Pain Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: baseline
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°.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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
Measured: baseline
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start10 Jun 2023
- Primary completion20 Jul 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Medhat EM [mmofty], Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842200
- Sponsor's protocol ID
- PFPS and lower limb alignment
- Status last verified
- Jan 2024
- First submitted
- 24 Apr 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Selected Lower Limb Biomechanical Variables on Pain, Disability and Balance in Women With Patellofemoral Pain Syndrome: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT05842200
- Acronym / sponsor ID
- PFPS and lower limb alignment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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) .
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°.
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.
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.
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Is spinopelvic sagittal alignment correlated with pain level, functional disability and frontal plane projection angle in women with patellofemoral pain syndrome? A cross-sectional studyLink provided by the sponsor.
- Comparison of selected lower limb biomechanical variables between university of ibadan sportsmen with and without patellofemoral pain syndromeLink provided by the sponsor.
- Evaluation of postural balance using the biodex balance system in subjects with and without low back painLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medhat EM [mmofty] study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome and Patellofemoral Malalignment Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there an impact of dynamic knee valgus on pain, disability and balance in women with patellofemoral pain? (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.