Patellofemoral Pain SyndromeNCT05348850
Quadriceps Muscle Contractile Properties and Functional Performance
An observational study of Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the association between tensiomyography parameters (from rectus femoris, vastus lateralis and vastus medialis) and functional abilities in runners with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Tensiomayography (TMG)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 1 Jan 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 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: 30 Distance runners selected from Egyptian clubs will participate in the study.
Who may be able to join
- The athletes age range between 18-30 years old will participate in this study.
- Both males and females will participate in this study.
- All athletes will be selected from long-distance runners.
- All athletes have an average running period (6 days per week and 5 hours per day).
Who cannot join
- Athletes with foot deformities such as hallux valgus, foot supination, pes planus, and pes cavus,
- Athletes with biomechanical abnormalities and complications affecting walking ability and performance.
- History of lower limbs or back surgery or injury.
- Structural or functional leg length discrepancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Contractile Properties of Quadriceps Muscle and Functional Performance in Runners With Patellofemoral Pain Syndrome
The aim of this study is to investigate the association between tensiomyography parameters (from rectus femoris, vastus lateralis and vastus medialis) and functional abilities in runners with patellofemoral pain syndrome.
Read the detailed description
Running is one of the most widespread activities during which overuse injuries of the lower extremity occur. Long-distance running is very popular among participants of recreational sports . In 2008, about 11.5% of the population in the United States ran and, of this group, 3.4% ran on average two times a week or more. In Europe, it is estimated that 36% of the population aged 15-65 years are recreational runners.
Most running-related injuries occur in the lower extremities. The most common anatomical site of running injuries is the knee.
Risk factors for running injuries have been well investigated , However, because of the heterogeneity of the studies (e.g., definition of injury, recreational or elite runners, and short- or long-distance runners), no clear overview is available regarding the most important risk factors for running injuries. Increased training volume per week in male runners, and a history of previous injuries for runners, are known significant risk factors for running injuries.
The various purported risk factors for running injuries are commonly divided into intrinsic and extrinsic risk factors. Intrinsic risk factors include mostly anatomic and other variables that are innate to the individual, such as gender, age, height, weight, personality type (e.g., aggressive, passive), and anatomic factors such as femoral anteversion, genu varus or valgus, pes planus or cavus, bone density, muscular flexibility, and leg-length discrepancies. Extrinsic risk factors include training variables such as mileage, hill running, pace, interval training, equipment (shoes, shoe inserts), and training surfaces.
Patellofemoral pain syndrome is the most common overuse injury of the lower extremity, and is particularly prevalent in those who are physically active. For example, approximately 2.5 million runners will be diagnosed with PFPS in a given year. PFPS also is a significant problem in the military as it has been reported that 37% of recruits develop PFPS while in basic combat training. Females are reported to be at greater risks for PFPS than their male counterparts. Alarmingly, 70% to 90% of individuals with PFPS have recurrent or chronic pain, In addition, the result of a recent study suggest that having PFPS as a younger individual may predispose one to develop patellofemoral osteoarthritis later in life.
One of the most common risk factors of patellofemoral pain syndrome is the imbalance of the quadriceps musculature and maltracking of the patella are 2 potential factors that may lead to PFP.
The nature of PFP is multifactorial, and many risk factors have been associated with this condition. This come in agreement with several authors who reported that patellofemoral pain syndrome is one of the most common injuries in runners.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Tensiomayography (TMG)
- Keywords
- Runners
- 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.
Tensiomayography (TMG)Device
Quadriceps muscle contractile properties will be assessed using tensiomayography
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Athletes with patellofemoral pain syndrome will be selected Muscle contractile properties and functional performance will be assessed for athletes with patellofemoral pain syndrome .
Data will be collected from all athletes regarding age, gender, training intensity running experience and previous injuries.
By the end of the assessment it will be detected if muscle contractile properties of vastus medialis and vastus lateralis is a determinant factor that influence functional performance in runners with patellofemoral pain syndrome. Receives: Device: Tensiomayography (TMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractile properties of Quadriceps muscle for 30 runners with patellofemoral pain syndrome
Will be assessed using Tensiomayography
Measured: measured at the baseline as it is a cross sectional study
Anteromedial lunge Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Anteromedial lunge test will be performed by each athlete for 3 trails with a 3 min recovery period between .
Measured: measured at the baseline as it is a cross sectional study
Step-down Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Step-down test will be performed by each athlete for 3 trails with a 3 min recovery
Measured: measured at the baseline as it is a cross sectional study
Balance and reach Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Balance and reach test will be performed by each athlete for 3 trails with a 3 min recovery
Measured: measured at the baseline as it is a cross sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start20 Apr 2022
- Primary completion20 Sep 2022
- Study completion1 Jan 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menan Aliy Eldeen Mohamed Elmahdy, Cairo University
- Investigators
- kahled ayad, Prof, Study chair, Professor of Orthopaedic Physical Therapy, Deraya University and Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348850
- Sponsor's protocol ID
- P.T.REC/012/003382
- Status last verified
- Jan 2023
- First submitted
- 13 Apr 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Contractile Properties of Quadriceps Muscle and Functional Performance in Runners With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05348850
- Acronym / sponsor ID
- P.T.REC/012/003382
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Runners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 27 Apr 2022 (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 aim of this study is to investigate the association between tensiomyography parameters (from rectus femoris, vastus lateralis and vastus medialis) and functional abilities in runners with patellofemoral pain syndrome.
Detailed description
Running is one of the most widespread activities during which overuse injuries of the lower extremity occur. Long-distance running is very popular among participants of recreational sports . In 2008, about 11.5% of the population in the United States ran and, of this group, 3.4% ran on average two times a week or more. In Europe, it is estimated that 36% of the population aged 15-65 years are recreational runners.
Most running-related injuries occur in the lower extremities. The most common anatomical site of running injuries is the knee.
Risk factors for running injuries have been well investigated , However, because of the heterogeneity of the studies (e.g., definition of injury, recreational or elite runners, and short- or long-distance runners), no clear overview is available regarding the most important risk factors for running injuries. Increased training volume per week in male runners, and a history of previous injuries for runners, are known significant risk factors for running injuries.
The various purported risk factors for running injuries are commonly divided into intrinsic and extrinsic risk factors. Intrinsic risk factors include mostly anatomic and other variables that are innate to the individual, such as gender, age, height, weight, personality type (e.g., aggressive, passive), and anatomic factors such as femoral anteversion, genu varus or valgus, pes planus or cavus, bone density, muscular flexibility, and leg-length discrepancies. Extrinsic risk factors include training variables such as mileage, hill running, pace, interval training, equipment (shoes, shoe inserts), and training surfaces.
Patellofemoral pain syndrome is the most common overuse injury of the lower extremity, and is particularly prevalent in those who are physically active. For example, approximately 2.5 million runners will be diagnosed with PFPS in a given year. PFPS also is a significant problem in the military as it has been reported that 37% of recruits develop PFPS while in basic combat training. Females are reported to be at greater risks for PFPS than their male counterparts. Alarmingly, 70% to 90% of individuals with PFPS have recurrent or chronic pain, In addition, the result of a recent study suggest that having PFPS as a younger individual may predispose one to develop patellofemoral osteoarthritis later in life.
One of the most common risk factors of patellofemoral pain syndrome is the imbalance of the quadriceps musculature and maltracking of the patella are 2 potential factors that may lead to PFP.
The nature of PFP is multifactorial, and many risk factors have been associated with this condition. This come in agreement with several authors who reported that patellofemoral pain syndrome is one of the most common injuries in runners.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Tensiomayography (TMG)Athletes with patellofemoral pain syndrome will be selected Muscle contractile properties and functional performance will be assessed for athletes with patellofemoral pain syndrome . Data will be collected from all athletes regarding age, gender, training intensity running experience and previous injuries. By the end of the assessment it will be detected if muscle contractile properties of vastus medialis and vastus lateralis is a determinant factor that influence functional performance in runners with patellofemoral pain syndrome. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 30 Distance runners selected from Egyptian clubs will participate in the study.
Key inclusion criteria (4 listed)
- The athletes age range between 18-30 years old will participate in this study.
- Both males and females will participate in this study.
- All athletes will be selected from long-distance runners.
- All athletes have an average running period (6 days per week and 5 hours per day).
Key exclusion criteria (4 listed)
- Athletes with foot deformities such as hallux valgus, foot supination, pes planus, and pes cavus,
- Athletes with biomechanical abnormalities and complications affecting walking ability and performance.
- History of lower limbs or back surgery or injury.
- Structural or functional leg length discrepancy.
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 |
|---|---|---|
| Tensiomayography (TMG)Quadriceps muscle contractile properties will be assessed using tensiomayography | Device | Study Group |
Primary outcome
Contractile properties of Quadriceps muscle for 30 runners with patellofemoral pain syndrome
Time frame: measured at the baseline as it is a cross sectional study
Will be assessed using Tensiomayography
Anteromedial lunge Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Time frame: measured at the baseline as it is a cross sectional study
Anteromedial lunge test will be performed by each athlete for 3 trails with a 3 min recovery period between .
Step-down Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Time frame: measured at the baseline as it is a cross sectional study
Step-down test will be performed by each athlete for 3 trails with a 3 min recovery
Balance and reach Functional Performance Test designed for 30 runners with patellofemoral pain syndrome
Time frame: measured at the baseline as it is a cross sectional study
Balance and reach test will be performed by each athlete for 3 trails with a 3 min recovery
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 17 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Patellofemoral Pain Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
RecruitingPhase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
Patellofemoral Pain Syndrome
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.
kahled ayad, Prof study chair
Professor of Orthopaedic Physical Therapy, Deraya University and Cairo University, Egypt
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 4 inclusion and 4 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 17 Jan 2023. 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?
Contractile properties of Quadriceps muscle for 30 runners with patellofemoral pain syndrome (time frame: measured at the baseline as it is a cross sectional study). The study lists 4 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 17 Jan 2023.