Trial document




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  DRKS00003352

Trial Description

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Title

Use of whole body vibration training as a company-facilitated sports activitiy fpr people with chronic back disorders

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Trial Acronym

VIBCOMBACK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A high proportion of sick days is caused by backache. Whole body vibration training is able to stimulate the musculature of the trunk and reduce back pain.
Study goal is to examine if a whole body vibration training is able to reduce backache in employees with chronic backache. Aside that it will be examined if physical capacity, coordination, quality of life and the number of sick days could be influenced by such an interention and how employees comply with it.

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Brief Summary in Scientific Language

Study goal is to examine if a whole body vibration training with 2 to 3 sessions per week for 3 months is able to reduce backache in employees with chronic backache. Aside that it will be examined if physical capacity, coordination, quality of life and the number of sick days could be influenced by such an intervention and how employees comply with it.
In a randomised and controlled study on mainly seated working male and female employees with chronic back disorders will be examined.

In the context of this randomised and controlled research project the subjects will be randomised in a intervention group and a control group consisting of 20 subjects each.
In preparation of the research project subjects will be excluded if they show afore defined contraindications for such an intervention.
The data collections are planned at the beginning of the interventinal phase and after the ending of it after 12 weeks.
For the subjects of the control group who will start the whole body vibration training afterwards an additional data collection only for descriptive reasons will be carried out. For the intervention and control group the differences between baseline and 12 weeks will be examined and these differences will be compaired. The subjects of the control group will not take part in any intervention for the first 12 weeks. The subjects of the intervention group will take part in a whole body vibration training for 2,5 times each week. The whole body vibration training will be carried out by the subjects widely independent after an extensive briefing by a trained person. A contat person for questions and problems is aviable at any time.

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Organizational Data

  •   DRKS00003352
  •   2011/11/30
  •   [---]*
  •   yes
  •   Approved
  •   5855b, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1126-1653 
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Health Condition or Problem studied

  •   chronic back pain
  •   M54.5 -  Low back pain
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Interventions/Observational Groups

  •   Whole body vibration training 2,5 times for 15 minutes each per week over a period of 12 weeks
  •   Control group without any intervention for 12 weeks
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Characteristics

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

The back-pain will be messured with the Roland-Morris low-back-pain questionnaire at start (T0) and after 12 weeks (T1)

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Secondary Outcome

The power of the trunk will be messured by isokinetic performance of the musculature of the trunk at start (T0) and after 12 weeks (T1)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2011/12/04
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

male and female subjects with chronic back pain

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Exclusion Criteria

- large, unstable gallstones and nephroliths
- thrombosis
- sugeries in the last 6-8 weeks
- artificial joint replacements in the last 6 months
- coronary heart disease or arterial occlusive disease
- insufficiently treated hypertension
- diabetes mellitus with advanced microangiopathies, gangrenes, diabetic feet, retinal problems
- cardiac or brain pacemaker
- pregnancy
- under 18 years of age
- acute inflammation of the musculoskeletal system (activated arthrosis or arthropathy)
- acute tendinopathies in body parts affected by the intervention
- acute hernias
- acute radicular pain or komplicate back pain
- recent fractures in body parts affected by the intervention
- rheumatoid arthritis
- epilepsy (secundary risk of injury)
- loop (<4 weeks after insertion of a loop with one hook)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Sportmedizin Medizinische Hochschule
    • Mr.  Prof. Dr. med.  Uwe  Tegtbur 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Institut für Sportmedizin Medizinische Hochschule Hannover
    • Mr.  Lothar   Stein 
    • Carl-Neuberg-Str. 1
    • 30625   Hannover
    • Germany
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    • Institut für Sportmedizin Medizinische Hochschule Hannover
    • Mr.  Lothar  Stein 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Sportmedizin Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Uwe  Tegtbur 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/24
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Trial Publications, Results and other Documents

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