Trial document




This trial has been registered retrospectively.
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  DRKS00013794

Trial Description

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Title

Cluster-randomized, controlled evaluation of a teacher led multi factorial school based back education program for 10 to 12-year old children

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study examines, if a 10month multifactorial teacher led back education program can reduce the prevalence of back pain and bad posture in 10- to 12 year old pupils. Furthermore is tested, if the program can improve core muscle strength, back friendly behavior and back care knowledge. Classes of fifth grade pupils of the participation schools were randomly assigned to either the control or the intervention group. Measures examined prior to and after the intervention period are: clinical orthopedic examiniation, back pain prevalence, health questionnaires, motor tests, back behavior test and back care knowledge test. The intervention group received 3 main components of the program: 1. Five lessons on back care knowledge, 2. posture awareness- and improvement training and 3. mandatory core muscle strengthening in classroom and at the beginning of every physical education class. The control group only took part in both tests and received no back care lessons or any additional material nor guidelines for any lesson.

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Brief Summary in Scientific Language

Background: The aim of this cluster-randomized, controlled study was to examine, whether a teacher-led multifactorial back education program can improve back pain, motor skills, back behaviour and back knowledge over a 10month period in pupils.
Methods : 176 children from two schools were cluster randomised into intervention and control group. The intervention program consisted of 3 parts: 1. knowledge improve-ment, 2. posture awareness training and 3. reducing muscular imbalances of the core muscles through mandatory back and abdominal muscle exercises at the beginning of each physical education lesson. Outcome measures were back pain prevalence (Point and 6 month prevalence), a clinical orthopaedic examination, a health questionnaire, motor test, back-behaviour trial and a knowledge test.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013794
  •   2018/01/24
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  •   yes
  •   Approved
  •   10-101-0165, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
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Interventions/Observational Groups

  •   The intervention program consisted of three parts: 1. knowledge improvement through five lessons on back care held by a teacher with provided material, 2. posture awareness training and improvement in the classroom by three posters and 3. reducing muscular imbalances of the core muscles through mandatory back and abdominal muscle exercises at the beginning of each physical education lesson.
  •   Control Group gets no additional back care lessons, no posters and receives the standard physical education as legally required by the national Curriculum.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Back pain prevalence: Point and in the last 6 months. Baseline measurements took place at the beginning of the school year (September 2010) ahead of the start of the intervention program. Follow up measurement took place at the end of the school year (July 2011) after the completion of the intervention program.

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Secondary Outcome

clinical orthopaedic examination, a health questionnaire, motor tests, back-behaviour Trial, knowledge test. Baseline measurements took place at the beginning of the school year (September 2010) ahead of the start of the intervention program. Follow up measurement took place at the end of the school year (July 2011) after the completion of the intervention program.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/09/27
  •   450
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   12   Years
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Additional Inclusion Criteria

Pupils in fifth grade

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Exclusion Criteria

Enrollment in another scientific trial

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Addresses

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    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Mr.  Prof. Dr. med. Dr. hc.  Joachim  Grifka 
    • Kaiser Karl V.-Allee 3
    • 93077  Bad Abbach
    • Germany
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    •   +49 9405 180
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    • Department of SportScience, University of Re-gensburg
    • Ms.  Prof. Dr.  Petra  Jansen 
    • Universitätstr. 31
    • 93053  Regensburg
    • Germany
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    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Ms.  Silvia  Dullien 
    • Kaiser Karl V.- Allee 3
    • 93077  Bad Abbach
    • Germany
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    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • Ms.  Silvia  Dullien 
    • Kaiser Karl V.- Allee 3
    • 93077  Bad Abbach
    • Germany
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Sources of Monetary or Material Support

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    • Orthopädische Klinik für die Universität Regensburg im Asklepios Klinikum Bad Abbach
    • 93077  Bad Abbach
    • Germany
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    • Vereinigte IKK
    • 81477  München
    • Germany
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    • BMW Werk Regensburg
    • Herbert-Quandt-Allee
    • 93055  Regensburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/07/31
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Trial Publications, Results and other Documents

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