Patellofemoral Pain SyndromeNCT06511362
Comparative Effects of Perturbation and Functional Stabilization Training on Patellofemoral Pain Syndrome
A study testing Functional stabilization training and perturbation exercises in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The main objective of this study is to determine the comparative effects of perturbation and functional stabilization training on pain, balance, and performance in athletes with patellofemoral pain syndrome(PFPS). Patellofemoral pain syndrome is one of the well known causes of anterior knee joint pain. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Functional stabilization training and perturbation exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 25 Aug 2024
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Anterior knee pain.
- Age between 15 to 30.
- Pain between 3 to 10 on NPRS.
Who cannot join
- patellar fracture.
- Intra-articular pathology( ligamental and meniscal injury of the knee).
- Knee surgery
- Fracture of hip, knee, shin bone and foot
- Vestibular and visual disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan sports board
Lahore, Punjab Province, 54660
Amna Shahid, T-DPT, 03344512823, amna.shahid@riphah.edu.pk
Athar Azeem, Dpt, 03350079772, atharazzem420@gmail.com
About this study
Official title: Comparative Effects of Perturbation and Functional Stabilization Training on Pain, Balance and Performance in Athletes With Patellofemoral Pain Syndrome
The main objective of this study is to determine the comparative effects of perturbation and functional stabilization training on pain, balance, and performance in athletes with patellofemoral pain syndrome(PFPS). Patellofemoral pain syndrome is one of the well known causes of anterior knee joint pain. Proximal and distal joint muscle imbalances are the most predisposing factors in knee pain especially knee cap. Anterior knee pain Increase during flexion of the knee, i.e., jumping, running, squatting and descending stairs. PFPS have a crucial impact on balance and functional activities, particularly for young athletes under the age 40. Individuals with PFPS manifest abnormalities in the dynamic and kinematic balance of the lower extremity. Participants between the age of 18-30 with knee pain and have difficulty performing the activities. Perturbation training is the part of the neuromuscular training program include the balancing activities that test the balance during the rehabilitation program. Functional stabilization training is used to improve the muscle control and strength. This particular program focuses on improving balance and determining the effect of training on prformance and balance of athletes with PFPS.
Read the detailed description
Patellofemoral pain syndrome is one of the best-known causes of anterior knee joint pain. Proximal and distal joint muscle imbalances are the most prevalent factors in knee pain, especially in the knee cap. Patellofemoral pain syndrome is the most prevalent reason that brings young individuals to sports clinics. Possible mechanism that is used to explain the possibility of the occurrence of PFPS has been identified as joint pain, which in turn causes reflexive inhibition of VMO, Glut max, muscular weakness, reduces knee function, and causes discomfort and pain in the knee joint. Pain is aggravated with repetitive activities such as squatting, descending stairs, running and jumping. Individuals with PFPS may experience a loss of equilibrium and impaired function due to a lack of proprioception. Neuromuscular electrical stimulation, hip abductors and external rotator strengthening with proprioceptive training, and mayofascial release to the gluteal medius are some of the techniques that can be used for the management of PFPS. Athletic performance depends on the number of skills that require balance and muscular control. This particular study focuses on the comparative effects of functional stabilization and perturbation training.
A randomized clinical study will be conducted at pakistan sports board Board in Lahore on athletes with patellofemoral pain syndrome. The sample size of the study was calculated using G.Power. Non -Probability convenient sampling technique will be used for research. The sample size will be 34. The sample will be split into 2 groups. FSE along with traditional treatment, will be given to Group 1 and perturbation training will be given to Group 2. Tools that will be used to assess the baseline measures include (NPRS), horizontal and vertical jump tests, the lower extremity functional scale (LEFS), 40-yard splint tests, and the star excursion balance test before and after the intervention. The data will be analyzed using SPSS version 25. First, the Shapiro-Wilk test will be used to determine the normality of the data; the P-value will be greater than 0.05, and the data will be distributed normally. After assessing the normality of the data, it will be decided whether a parametric or non-parametric test will be used withn and between two groups.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Functional stabilization training, perturbation exercises
- Keywords
- Anterior knee pain syndrome
- 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.
Functional stabilization trainingProcedure or surgery
At the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools.
perturbation exercisesProcedure or surgery
At the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools.
| Study group | Role | What they receive |
|---|---|---|
| Functional stabilization training (Group 1)) | Experimental | The participants will perform Lateral bridge and ventral bridge(6 weeks protocol,5 sets 30 sec, 5 sec hold of each rep), Isometric hip abduction/lateral rotation in standing (first 2 weeks 2 sets 20 reps), Hip abduction/lateral rotation/extension in sidelying ( 6 week 2 sets 20 reps), Hip abduction/lateral rotation with slight knee and hip flexion in sidelying ( 6 week , 2 sets , 20 reps), Pelvic drop in standing ( 6 weeks , 3 sets 12 reps ) Hip lateral rotation in closed kinetic chain ( 6 weeks, 3 sets , 12 reps ) Single-leg deadlift (6-8 weeks , 3 sets , 12 reps) Single-leg squat ( last 2 weeks ,3 sets 12 reps) Prone knee flexion (6 weeks 2-3 sets , 12 reps) Seated knee extension (90°-45° of knee flexion)( 6 weeks ,2-3 sets 12 reps ) Single-leg standing on unstable platform ( 3 sets) Receives: Procedure: Functional stabilization training |
| Perturbation training(Group 2) | Experimental | Perform perturbation exercises that involve double leg foam balance activity (30-second hold), tilt board balance training (30-second hold), and roller board (30-second hold). Receives: Procedure: perturbation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
A numerical pain rating scale
this numeric pain rating scale will use to assess the level of pain. This scale consist of values from 0 to 10. 0 represent to no pain where as 10 indicate to worst pain. Scale is subdivided into 3 level. Level 1 range from 0 to 3 interpret mild pain. Level 2 having range from 4 to 6 interpret individual has moderate pain and level 3 have value from 7 to 10 indicate the severe pain.
Measured: 10 months
horizontal jump test (meters)
This test will be used to assess the performance of athletes. Participants must stand with their toes behind the zero-centimeter mark with the tape measure and jump as far as they can with two feet with swinging arms and bending knees. In this test, the participant must land a stick and measure the distance from the takeoff to the contact point after jumping. This scale is rated as excellent if a female athlete covers a distance >1.91 meters; 1.90-1.71 meters indicates above average; 1.70-1.60 meters indicates average; distances between 1.59 and 1.47 meters indicate below average; and distances covered by the athlete <1.47 meters represent poor distance or performance.
Measured: 10 months
vertical jumps tests(cm)
Vertical jump test use to assess the performance of athlete(lower extremity strength). To perform this test athlete warm up for 10 minutes. Then, they perform this test by standing side onto the wall. Participants reach as high as possible with one hand mark as M1 after that they jump as high as possible, which mark as M2. Measure the distance between M1and M2. Distance measure in cm. The distance >60 cm consider as excellent, between 46-60 cm consider as above average, between 31-45 cm consider as average, 21-30 cm consider as below average and distance <20 cm consider as poor performance(strength)
Measured: 10 months
40-yard sprint test (sec)
This test is used to assess speed, agility, and quickness. In this test, mark a 40-yard distance on the floor. Athletes run from the starting point to the finishing point. The time in seconds was measured by using a stopwatch to cover the 40-yard (36.6-meter) distance.
Measured: 10 months
lower extremity functional scale
This test is used as a performance assessment tool. This test consists of 20 questions relating to the person's ability to perform tasks related to daily life. A scoring system is available to predict the functional level. 0-20 scores represent severe functional limitations. 21-40 scores indicate moderate functional limitation; 41-60 scores show mild functional limitation; and 61-80 scores show minimum and no functional limitation.
Measured: 10 months
star excursion balance test(cm)
The star excursion balance test (SEBT) is described as a tool to assess the dynamic balance. Draw a star shape with tape on the floor, separated by a 45-degree angle. It involves reaching in multiple directions, mostly eight, while maintaining balance on one leg. Anterior, anteromedial, lateral, anterolateral, medial, posteromedial, posterior, and posteromedial are the eight directions. Relative distance percentage in each direction is measured by using the formula average distance in one direction/leg length*100. The average distance is measured by taking 3 readings of distance in each direction and dividing by 3.Reading must be done with both the right and left legs.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Feb 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion25 Aug 2024 (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.
- More trials run by Riphah International 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amna Shahid, T-DPT, Principal investigator, Riphah inernational university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511362
- Sponsor's protocol ID
- REC/RCR & AHS/23/0478
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researcher
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Perturbation and Functional Stabilization Training on Pain, Balance and Performance in Athletes With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06511362
- Acronym / sponsor ID
- REC/RCR & AHS/23/0478
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Anterior knee pain syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 19 Jul 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 main objective of this study is to determine the comparative effects of perturbation and functional stabilization training on pain, balance, and performance in athletes with patellofemoral pain syndrome(PFPS). Patellofemoral pain syndrome is one of the well known causes of anterior knee joint pain. Proximal and distal joint muscle imbalances are the most predisposing factors in knee pain especially knee cap. Anterior knee pain Increase during flexion of the knee, i.e., jumping, running, squatting and descending stairs. PFPS have a crucial impact on balance and functional activities, particularly for young athletes under the age 40. Individuals with PFPS manifest abnormalities in the dynamic and kinematic balance of the lower extremity. Participants between the age of 18-30 with knee pain and have difficulty performing the activities. Perturbation training is the part of the neuromuscular training program include the balancing activities that test the balance during the rehabilitation program. Functional stabilization training is used to improve the muscle control and strength. This particular program focuses on improving balance and determining the effect of training on prformance and balance of athletes with PFPS.
Detailed description
Patellofemoral pain syndrome is one of the best-known causes of anterior knee joint pain. Proximal and distal joint muscle imbalances are the most prevalent factors in knee pain, especially in the knee cap. Patellofemoral pain syndrome is the most prevalent reason that brings young individuals to sports clinics. Possible mechanism that is used to explain the possibility of the occurrence of PFPS has been identified as joint pain, which in turn causes reflexive inhibition of VMO, Glut max, muscular weakness, reduces knee function, and causes discomfort and pain in the knee joint. Pain is aggravated with repetitive activities such as squatting, descending stairs, running and jumping. Individuals with PFPS may experience a loss of equilibrium and impaired function due to a lack of proprioception. Neuromuscular electrical stimulation, hip abductors and external rotator strengthening with proprioceptive training, and mayofascial release to the gluteal medius are some of the techniques that can be used for the management of PFPS. Athletic performance depends on the number of skills that require balance and muscular control. This particular study focuses on the comparative effects of functional stabilization and perturbation training.
A randomized clinical study will be conducted at pakistan sports board Board in Lahore on athletes with patellofemoral pain syndrome. The sample size of the study was calculated using G.Power. Non -Probability convenient sampling technique will be used for research. The sample size will be 34. The sample will be split into 2 groups. FSE along with traditional treatment, will be given to Group 1 and perturbation training will be given to Group 2. Tools that will be used to assess the baseline measures include (NPRS), horizontal and vertical jump tests, the lower extremity functional scale (LEFS), 40-yard splint tests, and the star excursion balance test before and after the intervention. The data will be analyzed using SPSS version 25. First, the Shapiro-Wilk test will be used to determine the normality of the data; the P-value will be greater than 0.05, and the data will be distributed normally. After assessing the normality of the data, it will be decided whether a parametric or non-parametric test will be used withn and between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional stabilization training (Group 1)) | Experimental | Procedure: Functional stabilization trainingThe participants will perform Lateral bridge and ventral bridge(6 weeks protocol,5 sets 30 sec, 5 sec hold of each rep), Isometric hip abduction/lateral rotation in standing (first 2 weeks 2 sets 20 reps), Hip abduction/lateral rotation/extension in sidelying ( 6 week 2 sets 20 reps), Hip abduction/lateral rotation with slight knee and hip flexion in sidelying ( 6 week , 2 sets , 20 reps), Pelvic drop in standing ( 6 weeks , 3 sets 12 reps ) Hip lateral rotation in closed kinetic chain ( 6 weeks, 3 sets , 12 reps ) Single-leg deadlift (6-8 weeks , 3 sets , 12 reps) Single-leg squat ( last 2 weeks ,3 sets 12 reps) Prone knee flexion (6 weeks 2-3 sets , 12 reps) Seated knee extension (90°-45° of knee flexion)( 6 weeks ,2-3 sets 12 reps ) Single-leg standing on unstable platform ( 3 sets) |
| Perturbation training(Group 2) | Experimental | Procedure: perturbation exercisesPerform perturbation exercises that involve double leg foam balance activity (30-second hold), tilt board balance training (30-second hold), and roller board (30-second hold). |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anterior knee pain.
- Age between 15 to 30.
- Pain between 3 to 10 on NPRS.
Key exclusion criteria (5 listed)
- patellar fracture.
- Intra-articular pathology( ligamental and meniscal injury of the knee).
- Knee surgery
- Fracture of hip, knee, shin bone and foot
- Vestibular and visual 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 |
|---|---|---|
| Functional stabilization trainingAt the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools. | Procedure or surgery | Functional stabilization training (Group 1)) |
| perturbation exercisesAt the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools. | Procedure or surgery | Perturbation training(Group 2) |
Primary outcome
A numerical pain rating scale
Time frame: 10 months
this numeric pain rating scale will use to assess the level of pain. This scale consist of values from 0 to 10. 0 represent to no pain where as 10 indicate to worst pain. Scale is subdivided into 3 level. Level 1 range from 0 to 3 interpret mild pain. Level 2 having range from 4 to 6 interpret individual has moderate pain and level 3 have value from 7 to 10 indicate the severe pain.
horizontal jump test (meters)
Time frame: 10 months
This test will be used to assess the performance of athletes. Participants must stand with their toes behind the zero-centimeter mark with the tape measure and jump as far as they can with two feet with swinging arms and bending knees. In this test, the participant must land a stick and measure the distance from the takeoff to the contact point after jumping. This scale is rated as excellent if a female athlete covers a distance >1.91 meters; 1.90-1.71 meters indicates above average; 1.70-1.60 meters indicates average; distances between 1.59 and 1.47 meters indicate below average; and distances covered by the athlete <1.47 meters represent poor distance or performance.
vertical jumps tests(cm)
Time frame: 10 months
Vertical jump test use to assess the performance of athlete(lower extremity strength). To perform this test athlete warm up for 10 minutes. Then, they perform this test by standing side onto the wall. Participants reach as high as possible with one hand mark as M1 after that they jump as high as possible, which mark as M2. Measure the distance between M1and M2. Distance measure in cm. The distance >60 cm consider as excellent, between 46-60 cm consider as above average, between 31-45 cm consider as average, 21-30 cm consider as below average and distance <20 cm consider as poor performance(strength)
40-yard sprint test (sec)
Time frame: 10 months
This test is used to assess speed, agility, and quickness. In this test, mark a 40-yard distance on the floor. Athletes run from the starting point to the finishing point. The time in seconds was measured by using a stopwatch to cover the 40-yard (36.6-meter) distance.
lower extremity functional scale
Time frame: 10 months
This test is used as a performance assessment tool. This test consists of 20 questions relating to the person's ability to perform tasks related to daily life. A scoring system is available to predict the functional level. 0-20 scores represent severe functional limitations. 21-40 scores indicate moderate functional limitation; 41-60 scores show mild functional limitation; and 61-80 scores show minimum and no functional limitation.
star excursion balance test(cm)
Time frame: 10 months
The star excursion balance test (SEBT) is described as a tool to assess the dynamic balance. Draw a star shape with tape on the floor, separated by a 45-degree angle. It involves reaching in multiple directions, mostly eight, while maintaining balance on one leg. Anterior, anteromedial, lateral, anterolateral, medial, posteromedial, posterior, and posteromedial are the eight directions. Relative distance percentage in each direction is measured by using the formula average distance in one direction/leg length*100. The average distance is measured by taking 3 readings of distance in each direction and dividing by 3.Reading must be done with both the right and left legs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researcher
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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.
Amna Shahid, T-DPT principal investigator
Riphah inernational university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional stabilization training and perturbation exercises in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AISHA SIDDIQA, MS-DPT (03180068205, ayeshamalik5905@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A numerical pain rating scale (time frame: 10 months). 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 19 Jul 2024.