- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692727
Taping and Patellar Maltraction in PFPS Patients
January 1, 2021 updated by: Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
The Effectiveness of Different Taping Methods Applied in Addition to Exercise in Patients With Patellofemoral Pain Syndrome
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06370
- Ankara Yıldırım Beyazıt University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise grup
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.
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Experimental: McConnell patellar taping grup
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.
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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.
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Experimental: Femoral rotational taping grup
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bisect offset index (BOI)
Time Frame: Change from baseline BOI at 6 weeks
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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.
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Change from baseline BOI at 6 weeks
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Change in Patellar tilt angle (PTA)
Time Frame: Change from baseline PTA at 6 weeks
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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.
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Change from baseline PTA at 6 weeks
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Change in Lateral patellofemoral angle (LPFA)
Time Frame: Change from baseline LPFA at 6 weeks
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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.
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Change from baseline LPFA at 6 weeks
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Change in Lateral patellar displacement (LPD)
Time Frame: Change from baseline LPD at 6 weeks
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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.
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Change from baseline LPD at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale (VAS)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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).
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Just before the treatment and at the end of 6-week treatment.
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Y balance test (YBT)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Kujala Patellofemoral Score (KPS)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Q angle
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Nottingham Health Profile (NHP)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Timed up and go test (TUG)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Stair climb test (SCT)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Genu Valgum/Varum
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Patella type
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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. |
Just before the treatment and at the end of 6-week treatment.
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Sulcus angle (SA)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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It is the deepest angle between the medial and lateral trochlear edges.
135 degrees and above are risk factors for patellofemoral osteoarthritis.
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Just before the treatment and at the end of 6-week treatment.
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Trochlear depth (TD)
Time Frame: Just before the treatment and at the end of 6-week treatment.
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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.
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Just before the treatment and at the end of 6-week treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 17, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
December 26, 2020
First Submitted That Met QC Criteria
December 30, 2020
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
January 1, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/76
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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