NCT04692727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

December 26, 2020

Last Update Submit

January 1, 2021

Conditions

Keywords

PFPSMagnetic Resonance ImagingMcConnellfemoral rotationtapingmalalignment

Outcome Measures

Primary Outcomes (4)

  • 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 from baseline BOI at 6 weeks

  • 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 from baseline PTA at 6 weeks

  • 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 from baseline LPFA at 6 weeks

  • 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.

    Change from baseline LPD at 6 weeks

Secondary Outcomes (11)

  • Visual analog scale (VAS)

    Just before the treatment and at the end of 6-week treatment.

  • Y balance test (YBT)

    Just before the treatment and at the end of 6-week treatment.

  • Kujala Patellofemoral Score (KPS)

    Just before the treatment and at the end of 6-week treatment.

  • Q angle

    Just before the treatment and at the end of 6-week treatment.

  • Nottingham Health Profile (NHP)

    Just before the treatment and at the end of 6-week treatment.

  • +6 more secondary outcomes

Study Arms (3)

Exercise grup

ACTIVE COMPARATOR

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.

Other: Exercise program

McConnell patellar taping grup

EXPERIMENTAL

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.

Other: Exercise programOther: McConnel patellar taping technique

Femoral rotational taping grup

EXPERIMENTAL

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.

Other: Exercise programOther: Femoral rotational taping technique

Interventions

* 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

Exercise grupFemoral rotational taping grupMcConnell patellar taping grup

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.

McConnell patellar taping grup

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.

Femoral rotational taping grup

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \[Bisect offset index (BOİ) ≥57 and / or patellar tilt angle (PTA) ≥15\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06370, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 27894177BACKGROUND
  • 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.

    PMID: 19052244BACKGROUND
  • 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.

    PMID: 25127530BACKGROUND
  • 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.

    PMID: 29925502BACKGROUND
  • 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.

    PMID: 27432215BACKGROUND
  • Callaghan MJ, Selfe J. Patellar taping for patellofemoral pain syndrome in adults. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD006717. doi: 10.1002/14651858.CD006717.pub2.

    PMID: 22513943BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ertuğrul Demirdel, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The information of the individuals being treated will be hidden from the researcher who will make the MRI measurements.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2020

First Posted

January 5, 2021

Study Start

December 17, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations