Effectiveness Of Core Stabilization Exercises In Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

The Effect Of Core Stabilization Exercises In Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05351814
• Other study ID #: 21-128
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: April 2022
• Source: Istinye University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.

20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with patellofemoral pain syndrome (PFPS) were included in the study; Patients with meniscus and ligament lesions, osteoarthritis, patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery, pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.

Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.

IMPLEMENTATION PROTOCOL

1. Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .

2. Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.

While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.

Description:

SUBJECT AND OBJECTIVE OF THE RESEARCH The term patellofemoral pain syndrome (PFPS) is defined as retropatellar or peripatellar pain that occurs as a result of physical and biomechanical changes that causes pain in the anterior part of the knee related to changes in the patellofemoral joint.

Patellofemoral pain is one of the most common musculoskeletal problems, accounting for approximately 9-10% of all musculoskeletal complaints and 20-40% of all knee problems. PFPS is frequently encountered among young, physically active individuals. It is a common knee problem. It occurs most frequently in women, athletes and soldiers.

Many factors such as decrease in quadriceps femoris strength, decreased flexibility, activity mismatch between vastus medialis obliqua and vastus lateralis obliqua muscles, rotations between femur and tibia, excessive subtalar pronation, positional changes in the kneecap have been associated with patellofemoral pain syndrome. In a systematic analysis, it was observed that patients with PFPS had a decrease in the abduction/external rotation/extension strength of the affected side when compared to healthy individuals.

In a guideline regarding foot problems; It has been reported that foot pronation causes internal rotation of the tibia or femur (femoral anteversion), which disrupts the patellofemoral mechanism, while the pessary sergeant places more stress on the patellofemoral mechanism, especially when a person is running, since less softening and a harder contact are provided for the leg when the foot hits the ground.

In a controlled study involving patients with chronic PFPS, it was found that there was no significant difference between arthroscopy and home exercise program compared to home exercise alone, and home exercise alone was very effective.

The target in PFPS rehabilitation; to restore the functions of the joint and relieve pain. The first step in traditional rehabilitation is to strengthen the Quadriceps femoris (QF) and Vastus medialis obliqua (VMO) muscles. The treatment program consists of Open kinetic chain/Closed kinetic chain (ACZ/CHZ), stretching (iliotibial band, QF, hamstring, gastrocnemius, gastrocsoleus) exercises.

It was concluded that isokinetic exercises prevent extensor strength loss in patellofemoral pain syndrome, but they are not sufficient alone. In another study, it was found that hip strengthening exercises in addition to knee strengthening exercises were more effective in both improving function and reducing pain in sedentary women with PFPS than the group performing knee strengthening exercises alone. it was observed that the pain decreased more in the group in which both closed kinetic chain exercises and hip strengthening exercises were given compared to the group given only closed kinetic chain exercises.

In a randomized controlled study, core neuromuscular training was given in addition to routine physical therapy, and it was observed that patients improved more than routine physical therapy. In another study, core muscle strengthening exercises were given in addition to routine physical therapy and it was observed that it improved both pain and dynamic balance in patients compared to routine physical therapy alone.

Weight-bearing exercises are more functional than non-weight-bearing exercises because they require multi-joint movement, facilitate a functional muscle recruitment pattern, and stimulate proprioceptors. Because of these advantages, clinicians often recommend weight-bearing exercises in the rehabilitation of PFPS patients.

One systematic analysis determined the efficacy of physical exercise as a conservative treatment for patellofemoral pain syndrome by looking at the results of ten moderate to high quality clinical studies and showed that the most effective patellofemoral pain syndrome management included strengthening exercises for the hip at baseline. Due to their role in knee biomechanics, the addition of stretching exercises for the external rotator and abductor muscles, core muscles and proprioceptive, neuromuscular exercises " reduces pain in patellofemoral pain syndrome".

In the light of all these studies, when the literature was examined, very few studies were found that examined the effect of core stabilization exercises in individuals with patellofemoral pain syndrome, and these studies were only studied on certain parameters on women. The aim of this randomized controlled study; To investigate the multifactorial effectiveness of core stabilization exercises applied in patients diagnosed with patellofemoral pain syndrome.

Research Questions and Hypotheses:

What are the effects of core stabilization exercises in patellofemoral pain syndrome? H0:

Core stabilization exercises are not effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement, posture in patellofemoral pain syndrome.

H1: effective. Core stabilization exercises are effective on pain, functional level, balance, flexibility, muscle strength, normal joint movement and posture in patellofemoral pain syndrome.

Material and Method:

The study was planned as a randomized controlled trial. The number of volunteers to take part in the study was determined using the G-Power program. In the study, the randomized controlled study of 'Foroughi et al.' 45 named "Effects of Isolated Core Postural Control Training on Knee Pain and Function in Women with Patellofemoral Pain Syndrome: α=0.05, power 80% and effect size 0.3 were taken as an example. As a result of the calculations, it was found that there should be a total of 18 people, 9 people in each group. However, for a good statistical calculation or for the loss of cases, it was decided to take twice the result of this calculation. A total of 40 people, 20 people in each group, will be included in the study.

20/60 years old/with retropatellar pain that occurs during at least two of the activities and persists for at least one month While patients diagnosed with PFPS were included in the study; Patients with meniscus and ligament lesions , osteoarthritis , patellofemoral dislocation and/or subluxation history, osseous anomalies and history of knee surgery , pregnancy status, and patients using analgesics and anti-inflammatory drugs will not be included in the study.

Individuals will be divided into two groups by computerized randomization. Control group; Traditional patellofemoral pain syndrome exercises, (n=20) Core stability group; Core stabilization and hip exercises will be given in addition to traditional patellofemoral pain syndrome exercises. (n=20) After obtaining the demographic information of the cases change, before and after the treatment; Visual analog scale (VAS) change, Kuala scale change, Trunk forward flexion flexibility change, Hamstring muscle flexibility change, Sit-reach test change, Q angle measurement change, Normal joint movement change, McGill stabilization tests change, Timed get up and go test change, Single leg jump test change, Y balance test change, Muscle strength change will be evaluated by the same person using the Corbin Posture analysis change and Foot posture index (FPI) change parameters.

IMPLEMENTATION PROTOCOL

1. Control group; traditional patellofemoral pain syndrome exercises; isometric exercises 3 sets of 10 repetitions in one session, balance exercise 30/45 sec, one leg balance exercise 45/60 sec , stretching exercises 4 sets 5 repetitions 20 sec duration, off kinetic chain (CHC) AND open kinetic chain (ACZ) exercises were planned as 3 sets for 4 weeks and 3 days a week .

2. Core stability group; In addition to traditional patellofemoral pain syndrome exercises; hip muscle strengthening exercises are 3 sets of 10 repetitions in each session, and (core) stabilization exercises are 1st and 2nd weeks 2 sets 15 repetitions 3rd and 4th weeks 2 sets 5 repetition was planned for 4 weeks and 3 days a week.

While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 20/60 years old/with

• Occur during at least two activities of prolonged sitting, climbing stairs or inclines, squatting, running and jumping

• Retropatellar pain persisting for at least one month

• persons diagnosed with patellofemoral pain syndrome by the doctor are included in the study.

Exclusion Criteria:

• Meniscus and ligament lesions

• Osteoarthritis

• patellofemoral dislocation and/or subluxation history

• Osseous anomalies and history of knee surgery

• Pregnancy status

• Patients using analgesics and anti-inflammatory drugs will not be included.

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Exercise
While the patients will be exercised with a physiotherapist 1 day a week, the treatment will be followed as a home exercise program 2 days a week.

Locations

Country	Name	City	State
Turkey	Istinye University	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic information form change	The patient's age, height, weight and disease history are questioned.	At baseline
Primary	The visual analogue scale(VAS) change	was described in a psychology journal in 1921. It is a visual scale, not a verbal one. This 11-point scale (from 0 to 10) has different names, but the verbal rating scale (VAS) is most often used. The VAS scoring has a 10 cm long straight line on which the patient can mark the degree of discomfort. For example, when measuring pain, you might have "no pain" on the left end of the line and "worst pain imaginable" on the right, or the like. The result can be read in millimeters (0 - 100 mm), or whole and half a centimeter (0 - 10 cm).	Change from baseline the visual analogue scale at 4 weeks
Primary	Kuala scale change	Kuala et al. He developed it in 1993 to assess subjective symptoms and functional limitations in PFPS. The score consists of 13 questions. These questions address activity-related pain when climbing stairs, squatting, running, jumping, performing weight-bearing activities, and sitting for long periods of time with the knee flexed. He also questions symptoms such as limping, swelling, patella subluxation, quadriceps muscle atrophy, lack of flexion, and flexion pain. The total score ranges from 0 to 100. A higher score indicates fewer complaints.	Change from baseline kuala scale at 4 weeks
Primary	Y balance test change	The Y Balance test (YBT) is the most common dynamic balance assessment used in clinical practice and research to evaluate dynamic balance in 3 directions of reach YBT measures dynamic balance during single leg stance and requires strength, proprioception, and flexibility. YBT is a contralateral leg reaching system in one-leg stance anterior (ANT), posterolateral (PL), and posteromedial (PM) directions. A composite score is then calculated by summing the distance reached in 3 directions of reach (ANT, PL, and PM) relative to leg length. It has been reported that YBT predicts injury based on overall access performance (different threshold points depending on the sample) and asymmetry between the limbs (anterior access difference greater than 4 cm). In a study, YBT revealed inter-interpretive test-retest reliability and minimal measurement error.	Change from baseline Y balance test at 4 weeks
Primary	Body front flexibility assessment change	In this test, the person stands on a 15 cm high block and leans forward without bending the knees and tries to touch the fingertip. The test evaluates the flexibility of the lumbar region, hamstring muscles and M. gastrocnemius. The distance between the fingertip and the wooden block surface is measured with a tape measure, and the values that pass the block surface are recorded in cm as positive, and the values below the block surface as negative.	Change from baseline Body front flexibility assessment at 4 weeks
Primary	Muscle strength change	Manual muscle testing does not consistently detect muscle strength deficiencies or clearly demonstrate the impact of such deficiencies on the knee. For this reason, functional performance testing may be preferred. Functional performance tests are a test for the knee and the entire lower extremity. 'Loudon et al.' He evaluated five different functional performance tests (anteromedial lunge, step-down, single-leg press, bilateral squat, balance reaching) in individuals with patellofemoral pain. All five of these tests revealed high reliability and correlated with changes in pain scales. Among these tests as muscle strength assessment in cases; anteromedial lunge, step down (step), balance reaching test will be used.; If the patient cannot stabilize the pelvis by standing (on one leg) for 1 minute on the affected leg (the other side pelvis falls), it was decided to perform it on our patients, based on the study, which is said to be a sign of weakness of the hip muscles.	Change from baseline Muscle strength at 4 weeks
Primary	Normal joint movement change	Measurement will be made with G-Pro, an Android application. The G-Pro app is a highly accurate reliable tool for measuring knee flexion angle. Its results were found to be more significant and more accurate than the results of conventional instruments . It is preferred because it is easy to apply and has high reliability.	Change from baseline Normal joint movement at 4 weeks
Primary	Corbin posture analyses change	Posture analyses will be performed to determine the changes in the posture of the individuals included in the study. These changes will be scored using the form prepared by Corbin et al. that includes lateral and posterior observations. This form is based on detecting postural disorders by observation made from the two planes mentioned and scoring them according to their severity. The scores will be added last and the postural status will be classified according to the total score. Postural anomalies were scored (0: none, 1: mild, 2: moderate, 3: severe). Postural scores obtained by looking from the lateral and posterior aspects are summed (0-2: excellent, 3-4: very good, 5-7: good, 8-11: moderate, 12= bad).	Change from baseline Corbin posture analyses at 4 weeks
Primary	Foot Posture index or (FPI) change	A six-item assessment scale (Foot Posture index or FPI) was developed in response to the need for a fast, easy and reliable method to measure foot position. The FPI consists of observing the bottom of the hind and forefoot of an individual standing in a relaxed position. The hindfoot is assessed by palpation of the talus head, observing the curves above and below the lateral malleoli, and inversion/eversion of the calcaneus. The forefoot consists of assessing the extent of abduction/adduction of the forefoot in the hindfoot, while checking the swelling in the talo-navicular joint area and the alignment of the medial longitudinal arch.	Change from baseline Foot posture index at 4 weeks
Primary	Assessment of hamstring muscle flexibility change	In the supine position, the hip and knee are fixed in 90 degree flexion. The pivot point of the goniometer is placed on the lateral condyle of the femur. The knee angle will be measured by extending the patient's knee with the fixed arm parallel to the lateral midline of the femur and the mobile arm following the fibula. By subtracting the angular value found from 90 degrees, the shortness value will be obtained.	Change from baseline Assessment of hamstring muscle flexibility at 4 weeks
Primary	Sit and reach test change	It was used for flexibility assessment. The patients will be asked to sit on the stretcher, with their legs extended and without shoes, and lean the soles of their feet on the front table. Then, the patient is asked to lie forward on the stretcher as much as possible, without flexing his knees, from his torso (waist and hip), and the extreme point where his fingers reach is cm. The best result will be recorded by measuring in terms of and repeating this test 3 times.	Change from baseline Sit and reach test at 4 weeks
Primary	Q angle measurement change	It will be measured with a goniometer in the supine position, with the hip and knee extended. Between the line drawn from the spina iliaca anterior superior (SiAS) to the middle of the patella and the line drawn from the middle of the patella between the tuberositas tibia, this lateral angle will be measured 3 times and recorded. The average of the measurements will be recorded.	Change from baseline Q angle measurement at 4 weeks
Primary	Mcgill stabilization tests change	Endurance tests known as McGill protocol; It was originally developed to evaluate core stabilization in patients with low back pain. This protocol consists of different endurance tests: lateral endurance, trunk flexor endurance, and trunk extensor endurance. In these tests, the time in seconds that the isometric posture is maintained is measured and recorded.	Change from baseline Mcgill stabilization tests at 4 weeks
Primary	Timed start and go test change	The patients will be asked to start from a sitting position in a chair, get up with the given command, walk the predetermined distance of 3 meters as fast as they can, and return to their places. The time from the time they get up from the chair and sit down again will be recorded with the stopwatch. The measurements will be repeated 3 times and the average will be recorded in seconds.	Change from baseline Timed start and go test at 4 weeks
Primary	Single leg jump test change	The patients begin the test in a position with their hands on their waists on one leg. Patients are asked to jump as far as possible in a parallel plane and land with the same leg. In the tape measure fixed to the ground, the distance between the patient's jump and the starting point is recorded in cm.	Change from baseline Single leg jump test at 4 weeks