Patellofemoral Pain SyndromeNCT06736756
Impact of Tensor Fascia Lata Stretch on Vastus Medialis Obliqus Activity
An observational study of Patellofemoral Pain Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Patellofemoral pain syndrome (PFPS) is one of the most typical causes of anterior knee pain in adolescents and young adults under the age of 50.It is believed that imbalanced action between quadriceps components, is the most contributing cause of PFPS.Investigating exercises that increase VMO muscle activation and… 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?
- Stretch Exercise
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: patients referred from orthopedic surgeon with diagnosis of PFPS
Who may be able to join
- Both genders.
- Body mass index (BMI) ranges from 18.5 to 29.9.
- Age ranges between 18 and 30 years old.
- Experience nontraumatic anterior knee pain.
- Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.
- Having at least one positive PFPS clinical tests including, patellofemoral compression, patellofemoral gliding or resistive quadriceps setting
Who cannot join
- Coexisting pathology around the knee, including patellar subluxation or dislocation.
- Previous knee surgery.
- Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
- Patients didn't receive physiotherapy treatment or use of non-steroidal anti-inflammatory drugs for knee pain in the previous 3 months.
- Any neurological or rheumatic disorders
- Pain intensity more than 5 (based on visual analogue scale)
Show all 9Show fewer
- Hip and ankle pathology.
- BMI more than 30%.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tasneem Khaled
Cairo
Tasneem Kh Fouad, Bachelor, 01015507353, tasnim.khaled@acu.edu.eg
About this study
Official title: Impact of Tensor Fascia Lata Stretch Prior to Squat on Vastus Medialis Obliqus Activity in Patellofemoral Pain Syndrome
Patellofemoral pain syndrome (PFPS) is one of the most typical causes of anterior knee pain in adolescents and young adults under the age of 50.It is believed that imbalanced action between quadriceps components, is the most contributing cause of PFPS.Investigating exercises that increase VMO muscle activation and enhance the ratio between VMO and VL have been a standardized target in literature.
Read the detailed description
Participants will have the assessed limb ready by shaving the hair on thigh and using alcohol swabs to clean the area from any residues.
For the VMO, a surface EMG electrode will be placed 4 cm superior and 4 cm medial to the supromedial boarder of patella at approximately 55 degrees to the long axis of the femur. As for the VL, the electrode will be placed 10 cm superior and 6-8 cm lateral to the superior lateral boarder of the patella and orientated 15 degrees to the vertical. All electrodes are self-adhesive (Figure 8) and will be connected to EMG sensors that will be attached and secured by double-sided tape.Each participant will perform three consecutive squats with 5 seconds interval break between each repetition. The squat depth will be kept at 50 degrees knee flexion. Mean muscle activity from three squat repetitions of VMO and VL is recorded and VMO:VL ratio is calculated. Afterward, each participant will perform the TFL stretch and repeat the three squats again.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Stretch Exercise
- 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.
Stretch ExerciseOther
To stretch Tensor fascia lata muscle,each participant starts with side lying position with the tested limb upmost. The lower limb (non-tested) is kept in hip and knee flexion to ensure stability. The tested limb is then taken into hip extension and adduction with knee extended. The exercise is held for 60 seconds and repeated 5 times with 10 seconds break intervals.
What is being measured
The primary outcome is the main question the study is designed to answer.
VMO muscle activity
VMO muscle activity during squat is assessed by EMG device
Measured: During the procedure
Secondary outcomes (1)
VMO to VL ratio
Ratio between VMO and VL activity during squat
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start30 Sep 2024
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
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.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Khaled Fouad Abdelghany, Ahram Canadian University
- Investigators
- Enas Fawzy, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736756
- Sponsor's protocol ID
- Patellofemoral Pain syndrome
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tensor Fascia Lata Stretch Prior to Squat on Vastus Medialis Obliqus Activity in Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06736756
- Acronym / sponsor ID
- Patellofemoral Pain syndrome
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 17 Dec 2024 (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.
Patellofemoral pain syndrome (PFPS) is one of the most typical causes of anterior knee pain in adolescents and young adults under the age of 50.It is believed that imbalanced action between quadriceps components, is the most contributing cause of PFPS.Investigating exercises that increase VMO muscle activation and enhance the ratio between VMO and VL have been a standardized target in literature.
Detailed description
Participants will have the assessed limb ready by shaving the hair on thigh and using alcohol swabs to clean the area from any residues.
For the VMO, a surface EMG electrode will be placed 4 cm superior and 4 cm medial to the supromedial boarder of patella at approximately 55 degrees to the long axis of the femur. As for the VL, the electrode will be placed 10 cm superior and 6-8 cm lateral to the superior lateral boarder of the patella and orientated 15 degrees to the vertical. All electrodes are self-adhesive (Figure 8) and will be connected to EMG sensors that will be attached and secured by double-sided tape.Each participant will perform three consecutive squats with 5 seconds interval break between each repetition. The squat depth will be kept at 50 degrees knee flexion. Mean muscle activity from three squat repetitions of VMO and VL is recorded and VMO:VL ratio is calculated. Afterward, each participant will perform the TFL stretch and repeat the three squats again.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients referred from orthopedic surgeon with diagnosis of PFPS
Key inclusion criteria (6 listed)
- Both genders.
- Body mass index (BMI) ranges from 18.5 to 29.9.
- Age ranges between 18 and 30 years old.
- Experience nontraumatic anterior knee pain.
- Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.
Key exclusion criteria (9 listed)
- Coexisting pathology around the knee, including patellar subluxation or dislocation.
- Previous knee surgery.
- Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
- Patients didn't receive physiotherapy treatment or use of non-steroidal anti-inflammatory drugs for knee pain in the previous 3 months.
- Any neurological or rheumatic disorders
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 |
|---|---|---|
| Stretch ExerciseTo stretch Tensor fascia lata muscle,each participant starts with side lying position with the tested limb upmost. The lower limb (non-tested) is kept in hip and knee flexion to ensure stability. The tested limb is then taken into hip extension and adduction with knee extended. The exercise is held for 60 seconds and repeated 5 times with 10 seconds break intervals. | Other | – |
Primary outcome
VMO muscle activity
Time frame: During the procedure
VMO muscle activity during squat is assessed by EMG device
1 secondary outcome
VMO to VL ratio
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- 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.
Enas Fawzy, Professor 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 Ahram Canadian 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasneem Abdelghany, Bachelor (01015507353, tasnim.khaled@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VMO muscle activity (time frame: During the procedure). 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 Dec 2024.