Patellofemoral PainNCT06735586
The Effect of Hip Strengthening Exercises and Taping in Patients With PFP With Dynamic Valgus
A study of Patellofemoral Pain and Valgus Deformity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of isolated quadriceps and hip strengthening exercises and both strengthening exercises and mulligan knee taping technique on pain, functional level and balance in patients with dynamic knee valgus and patellofemoral pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain, Valgus Deformity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 2 Apr 2023
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Anterior knee pain lasting more than 2 months
- > 10 degrees frontal plane valgus angle
- At least 3 pains on the 10 cm VAS scale in the last week
- Have symptoms for at least 2 months
- Patients aged 18 to 50 years
- To have at least 2 of the pains that occur during squatting, climbing stairs, descending and sitting
Who cannot join
- Neurological disease or sequelae
- Having an orthopedic injury that may affect lower extremity kinematics
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hip Strengthening Exercises and Taping on Pain, Function and Balance in Patients With Patellofemoral Pain Syndrome With Dynamic Valgus
The aim of the study is to investigate the effects of isolated quadriceps and hip strengthening exercises and both strengthening exercises and mulligan knee taping technique on pain, functional level and balance in patients with dynamic knee valgus and patellofemoral pain. In addition, in the groups investigators will create as randomized controlled, investigators give only strengthening exercise to one group and apply both exercise and taping to the other group and to investigate whether Mulligan taping, which is applied in addition to exercise in the treatment, has an effect on valgus correction, pain, functional level and balance, and contributes to the literature. It will also become clear how effective the strengthening exercises will be in correcting the dynamic valgus, how much participants will reduce patellofemoral pain, and whether they have an effect on the functional level and balance. There are not enough studies in the literature on strengthening exercises in patients with patellofemoral pain with dynamic valgus. İnvestigators will contribute to the literature by evaluating the effect of hip and quadriceps strengthening exercises on dynamic knee valgus and patellofemoral pain with 2D video analysis method and evaluating the results concretely. In addition to the strengthening exercises that investigators will apply to the other group, our other research target is to evaluate the Mulligan knee taping technique with 2D video analysis method and to investigate whether Mulligan knee taping treatment has an effect on the correction of dynamic valgus.
Read the detailed description
A total of 34 patients with anterior knee pain and dynamic valgus will be included in the study and randomly divided into 2 groups as Exercise and Taping (n=17) and Exercise (n=17). Hip and quadriceps strengthening exercises will be applied to the patients in the exercise group 3 times a week for a total of 6 weeks, and both strengthening exercises and mulligan rigid knee taping will be applied to the patients in the Exercise and Taping group, again for 6 weeks and 3 times a week. If the participants in the study have bilateral anterior knee pain, the more symptomatic side will be included in the study.
Outcome measurements will be performed on the baseline (first day-before first treatment) and at the end of the 6 weeks treatment program.
NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah,USA) program will be used for statistical analysis. While evaluating the study data, descriptive statistical methods (Mean, Standard Deviation, Median, Frequency, Ratio, Minimum, Maximum) as well as the distribution of the data will be evaluated with the Shapiro-Wilk Test.
Mann-Whitney U Test will be used in comparisons of two groups that cannot show normal distribution of quantitative data, and Student's t test will be used in case of normal distribution. Significance will be evaluated at the p<0.05 level.
- Conditions
- Patellofemoral Pain, Valgus Deformity
- Being tested
- neuromuscular control exercise, neuromuscular control exercise and taping
- Keywords
- Dynamic Knee Valgus, Patellofemoral Pain
- 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.
neuromuscular control exerciseProcedure or surgery
All of the 17 participants participating in the study will be included in the 6-week exercise program investigators created after the initial evaluations. Exercises will be done 3 times a week, 10 sets of each exercise. And the participants will be given a rest period of 3 minutes between each set.1st and 2nd (5 times) week exercise program: Non-weight bearing exercises will be given in the first week; lateral hip abduction, clam shell exercises, and bridging exercises. 3rd and 4th week (5 times) exercises: This week investigators will give controlled weight lifting exercises:pelvic drop exercise, single leg squat exercise,step down exercise,single leg raise exercise. 4th and 5 th week exercise: lateral band walks, side lunges, forward lunges, and back lunges. 5 th and 6 th week exercise: Plyometric exercises: jump exercise, BOSU single knee scales exercise,resistive single leg squats,resisting vertical bridge.
neuromuscular control exercise and tapingProcedure or surgery
Exercises and taping will be done 3 times a week, 10 sets of each exercise. Mulligan Knee Taping Application: The application was made with Protape 38mm x 10 m rigid tape. The application will be performed in the participant's foot, with the hip and knee in internal rotation, and the knee in 20º flexion. The tape will be applied starting from the head of the fibula, passing over the tibia anteriorly, passing under the medial joint line of the knee and ending at the back of the knee, bringing the tibia to internal rotation.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular control exercises plus taping | Experimental | İnvestigators will apply the Mulligan knee taping technique to the participants in the randomized exercise and taping group, in addition to the hip focused and quadriceps strengthening exercises, 3 times a week for a total of 6 weeks. Receives: Procedure: neuromuscular control exercise and taping |
| Neuromuscular control exercises | Active comparator | All of the 17 participants participating in the study will be included in the 6-week exercise program investigators created after the initial evaluations. Exercises will be done 3 times a week, 10 sets of each exercise. And the participants will be given a rest period of 3 minutes between each set. Receives: Procedure: neuromuscular control exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior knee pain scale
measures the index function. the lowest 0 takes the highest 100 value.
Measured: 6 week
Secondary outcomes (7)
Visual analog scale
İnvestigators will evaluate pain with the VAS scale.The lowest value will be scored as 0 and the highest value as 10.Those with a value of 3 or more will be included in the study. The first and last day will be evaluated.
Measured: 6 week
Y Balance Test
Dynamic balance measurements of patients will be evaluated with Y balance test. In the test set up, 3 measuring tapes will be glued to the ground with an angle of 120 between them. The patient will be asked to stand on one foot at the intersection of these 3 tapes, reach with the tip of the toe in these 3 directions with the other foot, anterior, posteromedial and posterolateral, and return to the starting position.
Measured: 6 week
Frontal plane projection angle
In our study, our participants will be evaluated with single leg squat test and 2D video analysis method on the first and last day.Individuals will be asked to stand on one leg and bend their knees. The dynamic knee valgus of the participants who are positioned in 45º-60º flexion and observed from the frontal plane for 5 seconds will be evaluated.
Measured: 6 week
Patellar tilt test
It is used to assess the tension of the lateral retinacular structures. With the patient lying in the supine position with the knee fully extended, investigators will evaluate with 2 fingers or 4 fingers whether there is a difference between the medial and lateral vertical heights of the patella. A lateral tilt is considered positive if the lateral side height is less than the medial side height.
Measured: 6 week
Muscle strength measurement
Muscle strength measurements will be made with MicroFET2 hand dynamometer, whose reliability has been proven as isometric muscle strength measurement. Knee extension, hip external rotation, hip extension, hip abduction muscle strength will be measured.
Measured: 6 week
Hip external rotation and internal rotation E.H.A measurements
The patient is sitting with his legs hanging off the table from the knee, and the measurement will be made with a goniometer.
Measured: 6 week
Q angle measurement
The q angle is the angle between the line extending from the anterior superior of the spina iliaca to the midpoint of the patella and the line extending from the midpoint of the patella to the tuberositas tibia while the patient is standing.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start2 Jan 2022
- Primary completion22 Mar 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- By randomly dividing the individuals investigators included in our study into two groups, investigators applied only the hip and quadriceps strengthening program to one group and the additional Mulligan rigid taping technique to the hip and quadriceps strengthening exercises in the other group, and examined the first and post-test measurements investigators will make before and after each group separately, at the same time. İnvestigators are planning to evaluate the results investigators have obtained by making comparisons between groups in both groups. Dilber Coşkunsu, who is a blind evaluator, will make the evaluations. The person making the evaluation will make an evaluation without knowing which treatment the patient is receiving.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilber Karagozoglu Coskunsu, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735586
- Sponsor's protocol ID
- BahcesehirUn
- Other IDs
- Dilber Karagözoğlu Coşkunsu
- Status last verified
- Dec 2024
- First submitted
- 8 Apr 2023
- Last updated
- 16 Dec 2024
- Results posted
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hip Strengthening Exercises and Taping on Pain, Function and Balance in Patients With Patellofemoral Pain Syndrome With Dynamic Valgus
- ClinicalTrials.gov ID
- NCT06735586
- Acronym / sponsor ID
- BahcesehirUn
- Conditions
- Patellofemoral Pain, Valgus Deformity
- Keywords
- Dynamic Knee Valgus, Patellofemoral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 16 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.
The aim of the study is to investigate the effects of isolated quadriceps and hip strengthening exercises and both strengthening exercises and mulligan knee taping technique on pain, functional level and balance in patients with dynamic knee valgus and patellofemoral pain. In addition, in the groups investigators will create as randomized controlled, investigators give only strengthening exercise to one group and apply both exercise and taping to the other group and to investigate whether Mulligan taping, which is applied in addition to exercise in the treatment, has an effect on valgus correction, pain, functional level and balance, and contributes to the literature. It will also become clear how effective the strengthening exercises will be in correcting the dynamic valgus, how much participants will reduce patellofemoral pain, and whether they have an effect on the functional level and balance. There are not enough studies in the literature on strengthening exercises in patients with patellofemoral pain with dynamic valgus. İnvestigators will contribute to the literature by evaluating the effect of hip and quadriceps strengthening exercises on dynamic knee valgus and patellofemoral pain with 2D video analysis method and evaluating the results concretely. In addition to the strengthening exercises that investigators will apply to the other group, our other research target is to evaluate the Mulligan knee taping technique with 2D video analysis method and to investigate whether Mulligan knee taping treatment has an effect on the correction of dynamic valgus.
Detailed description
A total of 34 patients with anterior knee pain and dynamic valgus will be included in the study and randomly divided into 2 groups as Exercise and Taping (n=17) and Exercise (n=17). Hip and quadriceps strengthening exercises will be applied to the patients in the exercise group 3 times a week for a total of 6 weeks, and both strengthening exercises and mulligan rigid knee taping will be applied to the patients in the Exercise and Taping group, again for 6 weeks and 3 times a week. If the participants in the study have bilateral anterior knee pain, the more symptomatic side will be included in the study.
Outcome measurements will be performed on the baseline (first day-before first treatment) and at the end of the 6 weeks treatment program.
NCSS (Number Cruncher Statistical System) 2007 (Kaysville, Utah,USA) program will be used for statistical analysis. While evaluating the study data, descriptive statistical methods (Mean, Standard Deviation, Median, Frequency, Ratio, Minimum, Maximum) as well as the distribution of the data will be evaluated with the Shapiro-Wilk Test.
Mann-Whitney U Test will be used in comparisons of two groups that cannot show normal distribution of quantitative data, and Student's t test will be used in case of normal distribution. Significance will be evaluated at the p<0.05 level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- By randomly dividing the individuals investigators included in our study into two groups, investigators applied only the hip and quadriceps strengthening program to one group and the additional Mulligan rigid taping technique to the hip and quadriceps strengthening exercises in the other group, and examined the first and post-test measurements investigators will make before and after each group separately, at the same time. İnvestigators are planning to evaluate the results investigators have obtained by making comparisons between groups in both groups. Dilber Coşkunsu, who is a blind evaluator, will make the evaluations. The person making the evaluation will make an evaluation without knowing which treatment the patient is receiving.
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular control exercises plus taping | Experimental | Procedure: neuromuscular control exercise and tapingİnvestigators will apply the Mulligan knee taping technique to the participants in the randomized exercise and taping group, in addition to the hip focused and quadriceps strengthening exercises, 3 times a week for a total of 6 weeks. |
| Neuromuscular control exercises | Active comparator | Procedure: neuromuscular control exerciseAll of the 17 participants participating in the study will be included in the 6-week exercise program investigators created after the initial evaluations. Exercises will be done 3 times a week, 10 sets of each exercise. And the participants will be given a rest period of 3 minutes between each set. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Anterior knee pain lasting more than 2 months
- > 10 degrees frontal plane valgus angle
- At least 3 pains on the 10 cm VAS scale in the last week
- Have symptoms for at least 2 months
- Patients aged 18 to 50 years
Key exclusion criteria (3 listed)
- Neurological disease or sequelae
- Having an orthopedic injury that may affect lower extremity kinematics
- Pregnancy
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 |
|---|---|---|
| neuromuscular control exerciseAll of the 17 participants participating in the study will be included in the 6-week exercise program investigators created after the initial evaluations. Exercises will be done 3 times a week, 10 sets of each exercise. And the participants will be given a rest period of 3 minutes between each set.1st and 2nd (5 times) week exercise program: Non-weight bearing exercises will be given in the first week; lateral hip abduction, clam shell exercises, and bridging exercises. 3rd and 4th week (5 times) exercises: This week investigators will give controlled weight lifting exercises:pelvic drop exercise, single leg squat exercise,step down exercise,single leg raise exercise. 4th and 5 th week exercise: lateral band walks, side lunges, forward lunges, and back lunges. 5 th and 6 th week exercise: Plyometric exercises: jump exercise, BOSU single knee scales exercise,resistive single leg squats,resisting vertical bridge. | Procedure or surgery | Neuromuscular control exercises |
| neuromuscular control exercise and tapingExercises and taping will be done 3 times a week, 10 sets of each exercise. Mulligan Knee Taping Application: The application was made with Protape 38mm x 10 m rigid tape. The application will be performed in the participant's foot, with the hip and knee in internal rotation, and the knee in 20º flexion. The tape will be applied starting from the head of the fibula, passing over the tibia anteriorly, passing under the medial joint line of the knee and ending at the back of the knee, bringing the tibia to internal rotation. | Procedure or surgery | Neuromuscular control exercises plus taping |
Primary outcome
Anterior knee pain scale
Time frame: 6 week
measures the index function. the lowest 0 takes the highest 100 value.
7 secondary outcomes
Visual analog scale
Time frame: 6 week
Y Balance Test
Time frame: 6 week
Frontal plane projection angle
Time frame: 6 week
Patellar tilt test
Time frame: 6 week
Muscle strength measurement
Time frame: 6 week
Hip external rotation and internal rotation E.H.A measurements
Time frame: 6 week
Q angle measurement
Time frame: 6 week
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 16 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Patellofemoral Pain and Valgus Deformity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 3 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 16 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 Turkey (Türkiye). 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?
Anterior knee pain scale (time frame: 6 week). 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 16 Dec 2024.