Trial document




drksid header

  DRKS00004977

Trial Description

start of 1:1-Block title

Title

MiSpEx-Network [National Research Network for Medicine in Spine Exercise]
National Research Network for Diagnosis, Prevention and Therapy of back pain in elite Sports and general population - MiSpEx-Multicenter-Interventionstudy

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

Trial Acronym

MiSpEx - Intervention Study

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 validation of preventiv and therapeutic interventions to reduce risk of back pain and and medical condition in elite sports and the general population. Training intervention for the trunk (unimodal) and in Kombination with behavioural therapy (multimodal) are evaluated to a control group (no intervention). Intervention phase is 12 weeks and a total of 24 weeks are screened to assess sustainability. Subjects between 18 and 65 years with/without back pain out of the general population and elite athletes will be recruted.

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, back pain is accompanied with a reduced load bearing capacity in elite sports and it is one major reason for absenteeism at the workplace. This results in a high burden for the health system. The clinical problem is in high loading situations in sport and for subjects with insufficient trunk muscles especially distinct. For development and persistence of medical condition, predominantly deficits on a neuronal, muscular and/or structural level are seen as relevant. Additionally, psycho-social factors are evident. Exercise intervention showed a high efficiency in the prevention and rehabilitation of structural and functional conditions. In contrast, for individual cases the dose-effect relationship to produce adaptation on a structural and functional level resulting in reduced back pain are uncertain. Methods for differential diagnostics in elite sports or the general population need further validation. Due to this lack of evidence, currently an specific and targeted recommendation for back pain treatment is not possible. Therefore, the purpose of the study is the validation of preventiv and therapeutic interventions to reduce risk of back pain and and medical condition in elite sports and the general population. Method: efficacy of excercise intervention will be parameterized by (isolated/combined) adaptations of muscular and neuronal structures as well as pain perception. Training intervention for the trunk (unimodal) and in Kombination with behavioural therapy (multimodal) are evaluated to a control group. Intervention phase is 12 weeks and a total of 24 weeks are screened to assess sustainability. Subjects between 18 and 65 years with/without back pain out of the general population and elite athletes will be recruted.

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

Organizational Data

  •   DRKS00004977
  •   2013/05/16
  •   [---]*
  •   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 (unimodal): sensorimotor-/strengthening Training of the trunk (interventiontime:12 weeks; 3 session/week; 45min. each session)
  •   intervention group 2 (mulitmodal): sensorimotor-/strengthening Training of the trunk + educational therapie (interventiontime: 12 weeks; 3 session/week; 45min. each session)
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
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Back pain: assessment by Korff pain questionaire. Measurements: before intervention, after 3, 6, 12, 24 weeks

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

Secondary Outcome

1. back pain frequency in the last 3 month
2. postural control: center of pressure (COP) for a one-legged stance (force plate)
3. trunk strength: isokinetik trunk extension/flexion peak torque (Nm)
4. fatigue: jumping performance change pre/post fatigue test
Measurements: before intervention, after 3, 6, 12, 24 weeks

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

Recruitment

  •   Actual
  •   2013/05/21
  •   600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

18-65 years of age; subject understand german language; subject is capable to answer a questionnaire without help

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

Exclusion Criteria

acute infection; pregnancy; not able to stand allone; not able to get up from a lying position; disease that contra-induced excercise; acute back pain 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 other
    • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Mr.  Prof.  Philip  Kasten 
    • Fetscherstr. 74
    • 01307  Dresden
    • 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 other
    • Universitätsklinikum Heidelberg
    • Mr.  Dr.  Nikolaus  Streich 
    • Schlierbarcher Landstr. 200a
    • 69118  Heidelberg
    • 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 other
    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Mr.  Prof.  Winfried  Banzer 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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 other
    • Schön Klinik Rückeninstitut
    • Mr.  Dr. med.  Christian  Schneider 
    • Harlachinger Straße 51
    • 81547  München
    • 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
    • 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
  •   2014/10/26
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.