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Taping and Patellar Maltraction in PFPS Patients

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise program
McConnel patellar taping technique
Femoral rotational taping technique
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring PFPS, Magnetic Resonance Imaging, McConnell, femoral rotation, taping, malalignment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Yıldırım Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Exercise grup

McConnell patellar taping grup

Femoral rotational taping grup

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Change in Bisect offset index (BOI)
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.
Change in Patellar tilt angle (PTA)
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)
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)
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.

Secondary Outcome Measures

Visual analog scale (VAS)
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)
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)
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.
Q angle
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)
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)
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.
Stair climb test (SCT)
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.
Genu Valgum/Varum
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
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.
Sulcus angle (SA)
It is the deepest angle between the medial and lateral trochlear edges. 135 degrees and above are risk factors for patellofemoral osteoarthritis.
Trochlear depth (TD)
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.

Full Information

First Posted
December 26, 2020
Last Updated
January 1, 2021
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04692727
Brief Title
Taping and Patellar Maltraction in PFPS Patients
Official Title
The Effectiveness of Different Taping Methods Applied in Addition to Exercise in Patients With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
PFPS, Magnetic Resonance Imaging, McConnell, femoral rotation, taping, malalignment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomized controlled study:Three parallel treatment groups; the control group received only exercise therapy, while the other two groups received two different taping treatments in addition to exercise therapy.
Masking
Outcomes Assessor
Masking Description
The information of the individuals being treated will be hidden from the researcher who will make the MRI measurements.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise grup
Arm Type
Active Comparator
Arm Description
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.
Arm Title
McConnell patellar taping grup
Arm Type
Experimental
Arm Description
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.
Arm Title
Femoral rotational taping grup
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Hamstring, quadriceps, gastrocnemius, iliopsoas, iliotibial band (ITB), lateral and medial retinaculum stretching exercises Isometric exercises of vastus medialis, gluteus medius and external rotators Isotonic exercises of vastus medialis, gluteus medius and external rotators Closed kinetic chain exercises Balance and coordination exercises Core stabilization exercises
Intervention Type
Other
Intervention Name(s)
McConnel patellar taping technique
Intervention Description
Individuals are placed in a supine position with their knees extended and the quadriceps relaxed. A 5 cm wide hypoallergenic band is applied transversely over the patella without affecting the position of the patella. Then, it is started at the lateral edge of the patella with a rigid tape. The tape is terminated at the medial femoral condyle after a medial pull and / or medial tilt to the patella.
Intervention Type
Other
Intervention Name(s)
Femoral rotational taping technique
Intervention Description
This technique is applied in a standing position and hip extreme external rotation. Taping is started on the vastus medialis and is pulled diagonally from the anterior of the leg to the lateral and ends on the trochanter major.
Primary Outcome Measure Information:
Title
Change in Bisect offset index (BOI)
Description
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.
Time Frame
Change from baseline BOI at 6 weeks
Title
Change in Patellar tilt angle (PTA)
Description
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.
Time Frame
Change from baseline PTA at 6 weeks
Title
Change in Lateral patellofemoral angle (LPFA)
Description
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.
Time Frame
Change from baseline LPFA at 6 weeks
Title
Change in Lateral patellar displacement (LPD)
Description
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.
Time Frame
Change from baseline LPD at 6 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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).
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Y balance test (YBT)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Kujala Patellofemoral Score (KPS)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Q angle
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Nottingham Health Profile (NHP)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Timed up and go test (TUG)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Stair climb test (SCT)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Genu Valgum/Varum
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Patella type
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Sulcus angle (SA)
Description
It is the deepest angle between the medial and lateral trochlear edges. 135 degrees and above are risk factors for patellofemoral osteoarthritis.
Time Frame
Just before the treatment and at the end of 6-week treatment.
Title
Trochlear depth (TD)
Description
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.
Time Frame
Just before the treatment and at the end of 6-week treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University
City
Ankara
ZIP/Postal Code
06370
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27894177
Citation
Laugharne E, Bali N, Purushothamdas S, Almallah F, Kundra R. Variability of Measurement of Patellofemoral Indices with Knee Flexion and Quadriceps Contraction: An MRI-Based Anatomical Study. Knee Surg Relat Res. 2016 Dec 1;28(4):297-301. doi: 10.5792/ksrr.16.032.
Results Reference
background
PubMed Identifier
19052244
Citation
Nakagawa TH, Muniz TB, Baldon Rde M, Dias Maciel C, de Menezes Reiff RB, Serrao FV. The effect of additional strengthening of hip abductor and lateral rotator muscles in patellofemoral pain syndrome: a randomized controlled pilot study. Clin Rehabil. 2008 Dec;22(12):1051-60. doi: 10.1177/0269215508095357.
Results Reference
background
PubMed Identifier
25127530
Citation
Song CY, Huang HY, Chen SC, Lin JJ, Chang AH. Effects of femoral rotational taping on pain, lower extremity kinematics, and muscle activation in female patients with patellofemoral pain. J Sci Med Sport. 2015 Jul;18(4):388-93. doi: 10.1016/j.jsams.2014.07.009. Epub 2014 Jul 24.
Results Reference
background
PubMed Identifier
29925502
Citation
Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
Results Reference
background
PubMed Identifier
27432215
Citation
Callaghan MJ, Guney H, Reeves ND, Bailey D, Doslikova K, Maganaris CN, Hodgson R, Felson DT. A knee brace alters patella position in patellofemoral osteoarthritis: a study using weight bearing magnetic resonance imaging. Osteoarthritis Cartilage. 2016 Dec;24(12):2055-2060. doi: 10.1016/j.joca.2016.07.003. Epub 2016 Jul 16.
Results Reference
background
PubMed Identifier
22513943
Citation
Callaghan MJ, Selfe J. Patellar taping for patellofemoral pain syndrome in adults. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD006717. doi: 10.1002/14651858.CD006717.pub2.
Results Reference
background

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Taping and Patellar Maltraction in PFPS Patients

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