Effectiveness Of Core Stabilization Exercises In Patellofemoral Pain Syndrome

NCT05351814 | Unknown

• 1 other identifier: 21-128
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Core Stability; Patellofemoral Pain; Exercise Therapy; Core Balance; Flexibility

Outcome Measures

Primary Outcomes (15)

• Demographic information form change

  The patient's age, height, weight and disease history are questioned.

  At baseline

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Sıt and reach test at 4 weeks

• 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

• 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

• 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

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Exercise

Core Stability group

EXPERIMENTAL

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.

Other: Exercise

Interventions

Exercise OTHER

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.

Control group; Core Stability group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• /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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Berrak VARHAN, Assoc. Prof.

  Ethics committee protocol number 21-128

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Individuals will be divided into two groups by computerized randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSIOTHERAPIST

Model Details: 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)

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 28, 2022
• Study Start: March 14, 2022
• Primary Completion: May 20, 2022
• Study Completion: June 20, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)