Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011240

Trial Description

start of 1:1-Block title

Title

The biomechanical and neurophysiological effects of a patellar brace on patients with patellofemoral pain syndrome -A cross-sectional and longitudinal study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patellofemoral Pain is a collective term for pain in the anterior part of the knee joint which is typically provoked by activities that require loading or prolonged flexed knees. In most cases patellofemoral pain is treated with non-operative methods. Scientific studies indicate best results for physical exercise therapy to restore a muscular balance around the knee joint.
The exercise therapy can be supported by wearing a patellar stabilizing brace.
To what extent the patellar brace also influences muscular activity around the knee is part of this study. Therefore 50 patients suffering patellofemoral pain perform selected daily exercises once with and once without wearing a patellar brace. At the same time the study’s objective is to evaluate the additional benefits of a patellar brace for the treatment of patellofemoral pain. For this purpose two different groups of patients are compared with respect to their perceived pain, functional restrictions and muscular activity. The participants are assigned to 12 weeks home-based exercise programme in combination with the patellar brace Genumedi PT, or home-based exercise programme alone.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The objective of the prospective randomized controlled trial is to analyze the effectiveness of an elastic patellar brace in the therapy of patellofemoral pain syndrome.
Predisposing factors for patellofemoral pain are not only muscular dysfunctions of the knee surrounding muscles but also a malalignment of the patella or the lower limbs. These factors often lead to an abnormal patellar tracking and subsequently to adverse pressure on cartilage and bone, resulting in pain. In contrast to structural factors, neuromuscular factors are approachable to conservative therapy.
An important conservative treatment strategy is physical exercise therapy which includes flexibility, strength, mobilization and stabilization exercises for the knee surrounding muscles. In addition to that braces can be used to stimulate the sensorimotor system.
The present study investigates whether the use of braces has further positive effects on the muscular activity as an endpoint of proprioceptive processing.
Therefore 50 patients suffering patellofemoral pain perform selected daily exercises once with and once without wearing a patellar brace. At the same time the study’s objective is to evaluate the additional benefits of a patellar brace for the treatment of patellofemoral pain. For this purpose two different groups of patients are compared with respect to their perceived pain (Visual Analog Scale), functional restrictions (Kujala Score) and neuromuscular activity. The participants are assigned to 12 weeks home-based exercise programme in combination with the patellar brace Genumedi PT, or home-based exercise programme alone.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011240
  •   2016/11/24
  •   [---]*
  •   yes
  •   Approved
  •   083/2014BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M22.2 -  Patellofemoral disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   25 Patients with patellofemoral pain receive an exercise therapy programm for 12 weeks
  •   25 Patients with patellofemoral pain receive an exercise therapy programm (same as in Arm 1) in combination with the patellar brace Genumedi PT for 12 weeks
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Before the first and second Measurement (12 weeks later):
- Kujala Score (Questionary)
-Pain on Visual Analog Scale.

During four different activities (Hoppings, Walking, Stair climbing, Get up and sit down) once with and once without a patellar brace:
-Neuromuscular activity (Elektromyography of M. gastrocnemius, M. semitendinosus, M. biceps femoris, M. rectus femoris, M. vastus lateralis, M. vastus medialis)
-Pain on Visual Analog Scale

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

/

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/08/18
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   30   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

-Anterior knee Pain
-Indication of conservative therapy by a physician

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-history of surgical treatment or surgical indication of the knee joint
-injuries of the knee joint in the past 12 weeks

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Stuttgart
    • Mr.  Dr.  Wilfried  Alt 
    • Allmandring 28
    • 70569  Stuttgart
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Sportklinik Stuttgart
    • Mr.  Dr.  Daniel  Wagner 
    • Taubenheimstraße 8
    • 70372  Stuttgart
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universität Stuttgart
    • Mr.  Dr.  Wilfried  Alt 
    • Allmandring 28
    • 70569  Stuttgart
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Stuttgart
    • Ms.  Theresa  Kölle 
    • Allmandring 28
    • 70569  Stuttgart
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Landesgraduiertenförderung Universität Stuttgart
    • Mr.  Wilfried  Roth 
    • Geschwister-Scholl-Str. 24 C
    • 70049  Stuttgart
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/12/08
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.