Trial document




drksid header

  DRKS00005233

Trial Description

start of 1:1-Block title

Title

Evaluation of the functional trunkstability
MiSpEx-Network [National Research Network for Medicine in Spine Exercise]

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

Trial Acronym

MiSpEx- Parallel Study PS2

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

URL of the Trial

http://www.mispex.de/

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

Brief Summary in Lay Language

Purpose of the study is the prevention of back pain with the assessment of medical and biomechanical factors to evaluate functional trunk stability. Additionally, reasonalbe training interventions have to be developed to reduce the appearance of injuries. Finally, the efficiency of the different training interventions to enhance trunk stability/function for the individual subject has to be detected. Subjects between 18 and 50 years with or without back pain out of the general population and elite athletes will be recruited

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

Brief Summary in Scientific Language

Background: Back pain is a central health issue in industrial countries. The lifetime prevalence is reported with about 90%. In most of the cases deficits on the neuronal, muscular and/or structural level are seen as relevant for the injury development or pain persistence. Therefore, the trunk stability is characterized by the ability to preserve a "trunk-equilibrium" during external loading or "neuromuscular errors" (for sports and activity of daily life). The quantification of the trunk stability with kinematics for loading situation introduced by the extremities and the association between trunk kinematics and muscular activity is still unclear.
Aim: Therefore, the purpose of the study is the evaluation of the trunk stability by a detailed assessment of the adaptation of the trunk kinematics and muscular activity in load situations introduced by the extremities. Additionally, the effect of training interventions (strength, sensorimotor) to enhance the trunk stability has to be evaluated.
Method: efficacy of excercise intervention will be parameterized by adaptations of the trunk stability (kinematics) and muscular activity (EMG) as well as pain perception. Training intervention for the trunk with sensorimotor or strength focus are evaluated to a control group. Intervention phase is 6 weeks. Subjects between 18 and 50 years with/without back pain out of the general population and elite athletes will be recruited.

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

Organizational Data

  •   DRKS00005233
  •   2013/08/21
  •   [---]*
  •   yes
  •   Approved
  •   36/2011, Ethikkommission der Universität Potsdam
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

  •   M54 -  Dorsalgia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   control group: no intervention
  •   intervention group 1: sensorimotor training of the trunk (device-based). Training characteristics: 4 different exercises, 60min., 3 sessions/week, 6 weeks, center-based
  •   intervention group 2: strengthening training of the trunk (device-based). Training characteristics: 4 different exercises, 60min., 3 sessions/week, 6 weeks, center-based
  •   intervention group 3: strengthening training of the extremities with stabilisation of the trunk (device-based). Training characteristics: 4 different exercises, 60min., 3 sessions/week, 6 weeks, center-based
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), Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

kinematic adaptations for loading situations: assessment by the kinematics (time/angle measures). Before and after 6 weeks intervention.

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

Secondary Outcome

1. neuromuscular adaptation: assessment by the muscular activity (EMG: time/amplitude measures).
2. back pain: assessment by Korff pain questionaire and VAS (visuell analog scale).
3. postural control: center of pressure (COP) for a one-legged stance (force plate)
All measures are assessed before and after 6weeks intervention

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/08/15
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

18-50 years

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

Exclusion Criteria

- acute infection
- pregnancy
- not able to stand alone
- not able to fill out a german questionnaire alone
- disease that contra-induce excercise
- acute back pain recently occured in the last 7 days
- additional participation in a parallel MiSpEx study

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hochschulambulanz der Universität Potsdam
    • Mr.  Prof. Dr. med.  Frank  Mayer 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • 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 scientific-contact
    • Hochschulambulanz der Universität Potsdam
    • Mr.  Dr.  Steffen  Müller 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • 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
    • Hochschulambulanz der Universität Potsdam
    • Ms.  Charlotte-Bettina  Boettcher 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • 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
    • Bundesinstitut für Sportwissenschaft
    • Graurheindorfer Straße 198 (Haus 7)
    • 53117  Bonn
    • 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
  •   2014/10/13
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.