Taping and Patellar Maltraction in PFPS Patients

Not Applicable

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Other: Exercise program; Other: Femoral rotational taping technique; Other: McConnel patellar taping technique

• Registration Number: NCT04692727
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

Patellofemoral Pain Syndrome(PFPS) treatment is basically conservative, but there is no general consensus on the most appropriate therapeutic approach. The aim of this study was to examine the misalignment of the patellofemoral joint with MRI and compare the effectiveness of McConnell patellar taping and femoral lateral rotational taping techniques applied to exercise function on pain, patellar maltraction, functional status, balance and quality of life in patients with PFPS.

Detailed Description

This is a single blinded randomized controlled trial, will be conducted at Ankara Yıldırım Beyazıt UniversityYenimahalle Education and Research Hospital. Evaluations regarding the parameters and inclusion criteria at the stage of diagnosis will be carried out by the Specialist Physician, exercise therapy and taping practices by the Specialist Physiotherapist, and the MRI measurements by the Specialist Radiologist. Fixed probability stratified randomization method will be preferred in order to ensure proportional gender distribution in the formation of groups and participants will be divided into 3 groups. An exercise program that includes stretching, strengthening and balance exercises accompanied by physiotherapist in the clinic will be applied to all individuals participating in the study for 2 times/week X 6 weeks (12 sessions). Only the exercise program will be applied to the first group. To the second group; McConnell patellar taping technique will be applied using rigid tape(Leukotape® P Rigid Strapping Tape, 38 mm X 10 m, USA) in addition to the exercise program in each session.To the third group; femoral lateral rotation taping technique will be applied using rigid tape in addition to the exercise program. Patients' patellar maltraction, pain function, balance, and quality of life will be assessed before and after treatment with MRI and clinical testing.

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2020-12-26
• Study First Submitted QC: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-01
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Presence of anterior knee pain lasting more than 6 weeks
• Anterior or retropatellar knee pain is present in at least two activities (stair descending, stair climbing, squatting, running, jumping, sitting for a long time
• Presence of malalignment of patellofemoral joint in MRI examination [Bisect offset index (BOİ) ≥57 and / or patellar tilt angle (PTA) ≥15]

Exclusion Criteria

• presence of knee trauma history and/or previous knee surgery
• presence limitation in knee joint range of motion
• presence of meniscopathy or lesion in knee ligaments
• presence of patellar subluxation or dislocation
• presence of a neuromuscular (upper or lower motor neuron lesions), cardiovascular or rheumatological disease
• pregnancy status
• presence of MRI contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise grup	Exercise program	An exercise program that includes stretching, strengthening and balance exercises accompanied by physiotherapist in the clinic will be applied to all individuals participating in the study for 6 weeks, 2 times a week (12 sessions). Each session will take approximately 40 minutes and patients will be asked to repeat the exercises at least 2 sets a day at home when they are not in the clinic (other 5 days a week). The home program will be followed by the exercise daily form.
McConnell patellar taping grup	Exercise program	McConnell patellar taping technique will be applied using a rigid tape in addition to the exercise program applied to the exercise group. The tape will remain in the body for a maximum of 48 hours and will be renewed by the same physiotherapist in each session.
Femoral rotational taping grup	Exercise program	Femoral lateral rotation taping technique will be applied using a rigid tape in addition to the exercise program applied to the exercise group.The tape will remain in the body for a maximum of 48 hours and will be renewed by the same physiotherapist in each session.
Femoral rotational taping grup	Femoral rotational taping technique	Femoral lateral rotation taping technique will be applied using a rigid tape in addition to the exercise program applied to the exercise group.The tape will remain in the body for a maximum of 48 hours and will be renewed by the same physiotherapist in each session.
McConnell patellar taping grup	McConnel patellar taping technique	McConnell patellar taping technique will be applied using a rigid tape in addition to the exercise program applied to the exercise group. The tape will remain in the body for a maximum of 48 hours and will be renewed by the same physiotherapist in each session.

Primary Outcome Measures

Name	Time	Method
Change in Patellar tilt angle (PTA)	Change from baseline PTA at 6 weeks	The patellar tilt angle is the angle between the posterior line of the femoral condyles and the widest mediolateral line of the patella. Below 15 degrees is considered normal.
Change in Lateral patellofemoral angle (LPFA)	Change from baseline LPFA at 6 weeks	It is the angle between the line connecting the top points of the femoral condyles and the line drawn along the lateral facet of the patella. In general, the patellofemoral angle is more than 8 ° and is open laterally. Medial patency monitoring or an angle less than 8 ° is considered an abnormal slope.
Change in Lateral patellar displacement (LPD)	Change from baseline LPD at 6 weeks	In the axial plan, a line connecting the top of the medial and lateral condyles and a vertical line is drawn from this at the top of the medial femoral condyle. The distance between this perpendicular line and the medial edge of the patella is measured. This distance should not be more than 1 mm in normal knees.
Change in Bisect offset index (BOI)	Change from baseline BOI at 6 weeks	A reference line is drawn through the posterior of the femoral condyles in the axial plan. A line is drawn from the widest diameter of the patella. A perpendicular third line drawn from the deepest point of the trochlear groove divides the widest diameter of the patella into 2 parts (α, β). Bisect offset is defined as the ratio of the lateral part of the patella to the patellar width and is calculated by the formula \[α / (α + β) x100\]. Being above 57° is a risk factor for pain and patellofemoral joint degeneration.

Secondary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Just before the treatment and at the end of 6-week treatment.	Patients' pain will be assessed for three different situations: "at rest", "at activity" and "at night" before and after treatment. The patient is asked to mark the severity of pain on the 10 cm horizontal line \[left end(0) = no pain, right end(10)= unbearable pain \]. Data is measured with a standard ruler and results are recorded in centimeters (cm).
Y balance test (YBT)	Just before the treatment and at the end of 6-week treatment.	There are 3 bars of 1.5 meters long fixed to a 2.54 cm high central foot plate at an angle of 135 and 90 degrees between them. It is asked to lie down with the tip of the toe in 3 directions and the measurements are recorded.
Kujala Patellofemoral Score (KPS)	Just before the treatment and at the end of 6-week treatment.	The Kujala Patellofemoral Score developed by Kujala et al contains 13 questions in total. This score questions pain during stair-climbing activity, squatting, running, jumping, and prolonged sitting in knees flexion. It also assesses whether there is disruption, swelling or patellar subluxation, the amount of atrophy in the quadriceps muscle, the presence of flexion deficit, and the need for walking aid. The scoring system ranges from 0 to 100 points, from poor to best . Turkish version of Kujala Patellofemoral Score will be used in individuals with PFPS.
Sulcus angle (SA)	Just before the treatment and at the end of 6-week treatment.	It is the deepest angle between the medial and lateral trochlear edges. 135 degrees and above are risk factors for patellofemoral osteoarthritis.
Q angle	Just before the treatment and at the end of 6-week treatment.	Q angle is the angle formed by a line drawn from the anterosuperior iliac. The angle will be measured in the supine position with the knee in full extension and in two different situations (quadriceps relaxed or maximum voluntary contraction (MVC)).spine to the central patella and a second line drawn from central patella to tibial tubercle.
Nottingham Health Profile (NHP)	Just before the treatment and at the end of 6-week treatment.	Nottingham Health Profile Questionnaire will be used to evaluate the quality of life. This questionnaire is used to determine how individuals perceive their emotional, social and physical states at that moment. The questions constituting the questionnaire were composed of two options: yes / no. The questionnaire consists of 2 main sections and 6 subtitles (pain, emotional reactions, sleep, social isolation, physical activity, energy) and includes a total of 38 questions. The total score of each section is 100. The scores formed by the answer "Yes" show the negative characteristics of the individual.
Timed up and go test (TUG)	Just before the treatment and at the end of 6-week treatment.	Patients were asked to perform test at usual walking speed .initial testing standardized verbal instruction given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then walk back to sit down .Note time on stopwatch .The average of tests trail was measured as the mean of TUG.
Genu Valgum/Varum	Just before the treatment and at the end of 6-week treatment.	The patient is standing. The patient is asked to touch the lower extremities while maintaining knee extension. If the medial condyles are in contact and the distance between the medial malleoli is more than 1 cm, it is evaluated as genu valgum. If the medial malleoli are in contact and the distance between the medial condyles is more than 1 cm, it is considered as genu varum.
Patella type	Just before the treatment and at the end of 6-week treatment.	Type 1: Medial and lateral facets are concave and almost equal. Type 2: The medial facet is concave and slightly smaller than the lateral facet.; Type 3: The medial facet is convex and smaller than the lateral facet.
Trochlear depth (TD)	Just before the treatment and at the end of 6-week treatment.	It is measured as the distance from the deepest point of the trochlear sulcus to the line connecting the anterior peaks of the femoral condyles. Below 3 mm is defined as abnormal.
Stair climb test (SCT)	Just before the treatment and at the end of 6-week treatment.	It is a test that evaluates the patient's staircase up and down activity, lower limb strength, and dynamic balance. The patient is asked to climb up and down 9 steps of 20 cm height as quickly as possible, and the activity time is recorded with a stopwatch. The measurements are repeated 3 times and the average is recorded in seconds.

Trial Locations

Locations (1)

Ankara Yıldırım Beyazıt University; 🇹🇷 Ankara, Turkey