Trial document




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  DRKS00010129

Trial Description

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Title

MiSpEx-Network [National Research Network for Medicine in Spine Exercise]
National Research Network for Diagnosis, Prevention and Therapy in back pain for elite athletes and the General population
- MiSpEx-Multicenterstudy with Intervention

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Trial Acronym

MiSpEx-MCSB

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URL of the Trial

http://www.mispex.de/

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Brief Summary in Lay Language

Purpose of the study is the validation of preventive and therapeutic interventions to reduce risk and symptoms of back pain in elite athletes and the general population. Training Intervention for the trunk will be evaluated in comparison to a control Group (no Intervention). 12 weeks Intervention phase will be applied with an overall obervational period of 12 month to assess the sustainability. Elite athletes and subjects out of the general population with the age of 18 to 65 years will be included in the study.

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Brief Summary in Scientific Language

Background: chronic unspecific back pain schow a life time prevalence of 90% in the western industrial nations. Most commonly, back pain is accompanied with disability (Athletes) and work time absenteeism. Back pain is especially relevant in high intensity loading Situation in sports and subjects with insufficiently trained trunk muscles. Deficits on a neuronal, muscular and/or structural Level are predominantly seen for the development and persistence of these medical condition. additionally, psychosocial risk factors are evident. Often, exercise interventions show high efficiency in prevention and rehabilitation. Nevertheless, the individual dose-response-relationship is unclear and possible adaptation on a structural and functional level with risk reduction and pain relief. Additionally, its unclear if a sensorimotor Training Intervention with perturbations can be applied to reduce back pain (disability) and risk of back pain occurence and to enhance functional marker.
Purpose: Purpose of the study is the validation of a therapeutic intervention (sensorimotor Trainig with perturbations) to reduce risk and symptoms of back pain in elite athletes and the general population

Methods: The Intervention will be evaluated in a prospective study design (randomised controlled Trial RCT). For intervention effect, the muscular and neuronal Adaptation and back pain (intensitiy, disability) will be quantified. Training Intervention will be analysed in comparison to a control Group. 12 weeks Intervention phase will be applied with an overall obervational period of 12 month to assess the sustainability. Elite athletes and subjects out of the general population with the age of 18 to 65 years will be included in the study.

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Organizational Data

  •   DRKS00010129
  •   2016/03/03
  •   [---]*
  •   yes
  •   Approved
  •   3/2016, Ethikkommission der Universität Potsdam
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M54 -  Dorsalgia
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Interventions/Observational Groups

  •   control group: no intervention
  •   intervention group (unimodal): sensorimotor and strengthening Excercise with Perturbation for the trunk. Intervention should be done 3-times a week for 12 weeks (3 weeks center- and 9 weeks home-based). each session will have a duration of 45 minutes.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Maximum trunk extension strength: assessment with isokinetic (isometric) Maximum trunk strength testing [Nm, N] for all 5 measurement days: pre Intervention, after 3, 12, 26 and 52 weeks

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Secondary Outcome

1. back pain: back pain related disability assessed by the von Korff questionaire
2. postural control: one legged stance on a ground reaction force plate with the Center of pressure path (COP) as outcome variable [cm]
3. Movement: trunk bendings in all 3 movement planes (flexion/extension, lateral flexion, rotation) with assessment of angle time pattern of the lumbar spine, pelvis and femur with 3D inertial sensors.
4. complex performance: counter movement jumps on a ground reaction force plate with maximum vertical jump force (Fz; [N]) and jump time [ms] as outcomes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • University Medical Center 
  • other 
  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2016/04/01
  •   1542
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- more then 3 days back pain in the last 12 month
- ability to understand the extent and meaning of the study
- ability to answer the questionaire without help
- written informed consent

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Exclusion Criteria

- acute infect
- pregnancy
- not possible to execute a one legged stance
- diseases with contraindication for exercise
- acute back pain appeared during the last 7 days

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Addresses

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    • Hochschulambulanz der Universität Potsdam
    • Mr.  Prof. Dr. med.  Frank  Mayer 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Ms.  Dr.  Heidrun  Beck 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik für Orthopädie und Unfallchirurgie, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie Heidelberg
    • Mr.  Prof  Marcus  Schiltenwolf 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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    • Johann Wolfgang Goethe-Universität Frankfurt am Main, Institut für Sportwissenschaft - Abteilung Sportmedizin
    • Mr.  Prof  Winfried  Banzer 
    • Ginnheimer Landstraße 39
    • 60487  Frankfurt am Main
    • Germany
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    • Schön Klinik Rückeninstitut
    • Mr.  Dr  Christian  Schneider 
    • Harlachinger Straße 51
    • 81547  München
    • Germany
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    • Ruhr-Universität Bochum, Lehrstuhl für Sportmedizin und Sporternährung
    • Ms.  Prof.  Petra  Platen 
    • Gesundheitscampus Nord 10
    • 44801  Bochum
    • Germany
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    • Hochschulambulanz der Universität Potsdam
    • Mr.  Prof. Dr. med.  Frank  Mayer 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • Germany
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    • Hochschulambulanz der Universität Potsdam
    • Ms.  Jessica  Messerschmidt 
    • Am Neuen Palais 10 Haus 12
    • 14469  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Bundesinstitut für Sportwissenschaft
    • Graurheindorfer Straße 198 (Haus 7)
    • 53117  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.