Patellofemoral Pain SyndromeNCT03897569
Association Between Ankle Dorsiflexion and Frontal Projection Angle in PFPS
An observational study of Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with PFPS. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- frontal projection angle, ankle dorsiflexion
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2019to 1 Jul 2019
- 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 35 years
- All sexes
- Adult
Study population: Subjects between 18 to 35 years old with symptomatic patellofemoral pain syndrome and healthy control.
Who may be able to join
- Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.
- Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6weeks.
- VAS equal to or greater than 3.
- Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.
- BMI under 30 kg/m2, both gender
- For the control group, subjects were recruited to this study if they had:
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- No previous history or diagnosis of knee pathology.
- No pain with any of the above-mentioned provocative activities.
- No history of lower limb or spinal pathology.
Who cannot join
- A history of any of the following condition: meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the lower extremities within the 12 months prior to participation in the study.
- Any balance impairments are secondary to a vestibular or neurological disorder or secondary to the use of medication.
- Any lower limb bony/congenital deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Ankle Dorsiflexion and Frontal Projection Angle During a Functional Task in the Patellofemoral Pain Syndrome
The study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with PFPS.
Read the detailed description
Altered frontal and transverse plane hip kinematics during single leg weight-bearing tasks are thought to be important contributors to patellofemoral pain (PFP). The closed chain nature of single leg tasks means that hip kinematics can be influenced by more distal mechanics, such as foot pronation.
One of the often-studied distal movements theorized to cause PFPS is pronation of the subtalar joint. Pronation is a tri-planar movement that includes dorsiflexion, eversion, and abduction of the foot. Many studies have examined eversion characteristics of PFPS patients, but the dorsiflexion aspect of the movement has been shown to be a possible risk factor, restricting dorsiflexion was shown to increase medial knee displacement in young healthy adults. Conversely, when available dorsiflexion ROM is increased, medial knee displacement is thought to decrease.
Patients with PFPS were observed to have a decreased DFROM (dorsiflexion range of motion) as compared to normal individuals, though this topic has not thoroughly been investigated.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- frontal projection angle, ankle dorsiflexion
- Keywords
- Patellofemoral Pain Syndrome, knee kinematics, frontal projection angle, ankle motion
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frontal projection angle, ankle dorsiflexionOther
Dorsiflexion measurements will be taken in 4 different positions and repeated and recorded 3 times in each position, Prone bent, straight knee and Standing bent, straight knee. Prior to the measurement, the participants completed two 30-second calf stretches The FPPA was determined as the angle at the knee formed by lines connecting the anterior superior iliac spine, the midpoint of the femoral condyles and the midpoint of the malleoli at the deepest part of the squat
| Study group | Role | What they receive |
|---|---|---|
| patellofemoral pain syndrome | twenty subjects with anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping. Receives: Other: frontal projection angle, ankle dorsiflexion | |
| control | twenty-six asymptomatic subject will be recruited for this study and should have no pain or other relevant clinical symptoms in the lower quadrant Receives: Other: frontal projection angle, ankle dorsiflexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal knee kinematic
The knee kinematic will be measured by using digital video camera using single leg squat during functional step down test
Measured: 20 minutes
Secondary outcomes (1)
Ankle mobility
Ankle dorsiflexion ROM will be assessed by bubble inclinometer during weight-bearing and non-weight-bearing positions.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start30 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- karima A Hassan, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897569
- Sponsor's protocol ID
- PFPS kinematics
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ankle Dorsiflexion and Frontal Projection Angle During a Functional Task in the Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03897569
- Acronym / sponsor ID
- PFPS kinematics
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, knee kinematics, frontal projection angle, ankle motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 1 Apr 2019 (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.
The study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with PFPS.
Detailed description
Altered frontal and transverse plane hip kinematics during single leg weight-bearing tasks are thought to be important contributors to patellofemoral pain (PFP). The closed chain nature of single leg tasks means that hip kinematics can be influenced by more distal mechanics, such as foot pronation.
One of the often-studied distal movements theorized to cause PFPS is pronation of the subtalar joint. Pronation is a tri-planar movement that includes dorsiflexion, eversion, and abduction of the foot. Many studies have examined eversion characteristics of PFPS patients, but the dorsiflexion aspect of the movement has been shown to be a possible risk factor, restricting dorsiflexion was shown to increase medial knee displacement in young healthy adults. Conversely, when available dorsiflexion ROM is increased, medial knee displacement is thought to decrease.
Patients with PFPS were observed to have a decreased DFROM (dorsiflexion range of motion) as compared to normal individuals, though this topic has not thoroughly been investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patellofemoral pain syndrome | – | Other: frontal projection angle, ankle dorsiflexiontwenty subjects with anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping. |
| control | – | Other: frontal projection angle, ankle dorsiflexiontwenty-six asymptomatic subject will be recruited for this study and should have no pain or other relevant clinical symptoms in the lower quadrant |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects between 18 to 35 years old with symptomatic patellofemoral pain syndrome and healthy control.
Key inclusion criteria (9 listed)
- Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.
- Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6weeks.
- VAS equal to or greater than 3.
- Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.
- BMI under 30 kg/m2, both gender
Key exclusion criteria (5 listed)
- A history of any of the following condition: meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the lower extremities within the 12 months prior to participation in the study.
- Any balance impairments are secondary to a vestibular or neurological disorder or secondary to the use of medication.
- Any lower limb bony/congenital deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frontal projection angle, ankle dorsiflexionDorsiflexion measurements will be taken in 4 different positions and repeated and recorded 3 times in each position, Prone bent, straight knee and Standing bent, straight knee. Prior to the measurement, the participants completed two 30-second calf stretches The FPPA was determined as the angle at the knee formed by lines connecting the anterior superior iliac spine, the midpoint of the femoral condyles and the midpoint of the malleoli at the deepest part of the squat | Other | control, patellofemoral pain syndrome |
Primary outcome
Frontal knee kinematic
Time frame: 20 minutes
The knee kinematic will be measured by using digital video camera using single leg squat during functional step down test
1 secondary outcome
Ankle mobility
Time frame: 20 minutes
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 30 Jul 2019.
- Individual participant dataSharing planned: No
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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.
karima A Hassan, PhD principal investigator
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, 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 9 inclusion and 5 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 30 Jul 2019. 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?
Frontal knee kinematic (time frame: 20 minutes). 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 30 Jul 2019.