Trial document




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  DRKS00009528

Trial Description

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Title

Impact of alternative exercise technologies on chronic low back pain in back pain patients under special regard of its sustainability.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Chronic back pains concern a large part of the population. The aim of the study is to evaluate the effects of Whole Body-Electromyostimulation (WB-EMS) and Whole Body Vibration (WBV) on chronic back pains in persons with chronic low back pain. Further it is our aim to determinate the sustainability of the intervention after the supervised exercise period.
A total of 234 male and female chronic back pain patients were randomly assigned to 3 groups (1-1-1) in each case in the study locations Erlangen and Cologne. Primary study outcome was changes of back pains, secondary study endpoint sustainability of the training realization.
Our hypothesis is that WB-EMS as well as WBV lowers the incidence of back pains significantly more pronounced than an intervention with conventional therapeutic exercises. Another hypothesis is, that WB-EMS and WBV-interventions generated a significantly higher sustainability compared with classical exercise programs.

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Brief Summary in Scientific Language

Chronic back pains concern a large part of the population. The aim of the study is to evaluate the effects of Whole Body-Electromyostimulation (WB-EMS) and Whole Body Vibration (WBV) on chronic back pains in persons with chronic low back pain. Further it is our aim to determinate the sustainability of the intervention after the supervised exercise period.
A total of 234 male and female chronic back pain patients become on 3 groups in each case in the study locations Erlangen and Cologne. Primary study endpoints were changes of back pains and sustainability of the training realization.
Our hypothesis is that WB-EMS as well as WBV lowers the incidence of back pains significantly more pronounced than an intervention with conventional therapeutic exercises. Another hypothesis is, that WB-EMS and WBV-interventions generated a significantly higher sustainability compared with classical exercise programs.

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Organizational Data

  •   DRKS00009528
  •   2015/10/15
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  •   yes
  •   Approved
  •   224_15B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   M54.8 -  Other dorsalgia
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Interventions/Observational Groups

  •   Whole Body Electromyostimulation for 14 weeks, 20 min, once per week (6 s current – 4 s rest, impulsfrequency 85 Hz, impuls-width: 350 ms,0,5 sec impuls-increase und -decrease) with devices of miha bodytec® (Gersthofen, Germany).
    After the supervised intervention: Assessment of the sustainability of the WB-EMS-intervention for a further 28 weeks.
  •   Video guided WB-Vibration for 14 weeks, 15 min, twice per week (side-alternating system, 10-30 Hz, 2-10 mm displacement) with devices of SVG® (Ötisheim, Deutschland). After careful instruction and briefing during the first 2-3 weeks, participants conducted a a video-guided WBV-Training.

    After the "supervised" intervention: Assessment of the sustainability of the WBV-intervention for a further 28 weeks.
  •   Usual care control-group that conducted a 45 min min session of conventional resistance exercise program partially performed on strength machines once per week for 14 weeks. The session was consistently supervised and designed as a group exercise session (10-12 participants) and should represent the common back programs of health care providers.
    After the "supervised" intervention: Assessment of the sustainability of the WBV-intervention for a further 28 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of chronic (low) back pain
at baseline and after 14 und 42 weeks via questionnaire:
-Chronic Pain Grade; German Version
-"Funktionsfragebogen" Hannover FFbHR
-partially: German Pain Questionnaire

Assessment of the sustainability of the intervention(s) after 14 and 42 weeks via questionnaire:
-Global Physical Activity Score
subanalysis via:
"Stadien-Flussdiagramm Sport":
-Scale: "Sport- und bewegungsbezogene Selbstkonkordanz"
-Scale "sportbezogenen situativen Barrieren und sportbezogenes Barrierenmanagement"
-Scale „sportbezogene Konsequenzerfahrung“.

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Secondary Outcome

-muscle mass of the trunk extensors (MRI)
-strength/power (isokinetic assessment)
-ADL and sportive activities (questionanaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2017/10/01
  •   234
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   70   Years
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Additional Inclusion Criteria

-chronic unspecific low back pain
-untrained, i.e. no special exercise training affecting strength or lower back during the last 6 months

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Exclusion Criteria

-WB-EMS spezific exclusion criterias (i.e. contraindikations: e.g. cardiac pace makers: thrombosis,hernias)

-WBV spezific exclusion criterias (i.e. contraindikations: e.g. e.g. cardiac pace makers: thrombosis, implants, artificial joints (back, lower extremities) , retinal detachment

- no known changes pharmacologic pain therapy during the intervention

- relevant psychological comorbidities

-diseases/medication affecting muscle metabolism

-absence of >2 weeks during the first intervention period of 14 weeks

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Addresses

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    • Friedrich Alexander Universität Erlangen-Nürnberg, Institut für Medizinische Physik,
    • Mr.  Professor Dr.  Wolfgang  Kemmler 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
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    • Deutsche Sporthochschule Köln (DSHS)Institut für Trainingswissenschaft und Sportinformatik
    • Ms.  Dr.  Ulrike  Dörmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Friedrich Alexander Universität Erlangen-Nürnberg, Institut für Medizinische Physik,
    • Ms.  MSc  Anja  Weißenfels 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
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    • Friedrich Alexander Universität Erlangen-Nürnberg, Institut für Medizinische Physik,
    • Ms.  MSc  Anja  Weißenfels 
    • Henkestrasse 91
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische PhysikFriedrich Alexander Universität Erlangen-Nürnberg
    • Mr.  Professor Dr.  Wolfgang  Kemmler 
    • Henkestrasse 91
    • 91052   Erlangen
    • Germany
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  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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