Trial document




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  DRKS00009752

Trial Description

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Title

Effect of osteopathic treatments on patients with chronic knee pain. A randomized controlled trial.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Chronic knee pain is a problem for many patients in all age groups. For example Petersson (1997) showed on 2000 people, aged between 35-54 years, that 15% of them had permanent knee pain. In this study, the effectiveness of osteopathic treatments compared to physiotherapy treatments to patients suffering from chronic knee pain will be carried out. It will be investigated whether the intensity of pain can be reduced and the quality of life can be improved

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Brief Summary in Scientific Language

The objective of this randomized controlled trial is to evaluate the effectiveness of osteopathic treatments compared to physiotherapy in patients suffering from chronic knee pain The outcome parameters are pain intensity (measured with the VAS and WOMAC) and quality of life (measured with the SF36)

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Organizational Data

  •   DRKS00009752
  •   2015/12/23
  •   [---]*
  •   yes
  •   Approved
  •   EKO03, Ethikkommission der Osteopathen Deutschlands (EKO), Römerschanzweg 5, 82131, Gauting, Deutschland, http://www.osteopathie-akademie.de
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Secondary IDs

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

  •   chronic knee pain
  •   M79.66 -  [generalization M79.6: Pain in limb]
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Interventions/Observational Groups

  •   6 osteopathic treatments over a period of 6 weeks. The first osteopathic treatment lasts 60 minutes, the following treatments 30 minutes
  •   6 physiotherapeutic treatments over a period of 6 weeks. The first physiotherapeutic treatment lasts 60 minutes, the following treatments 30 minutes
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Intensity of pain, measured with the Visual analogue scale VAS at the bingeing of every treatment

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Secondary Outcome

Specific questionnaire WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) and quality of life, measured with the SF36 at begin and end of treatment series

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Countries of Recruitment

  •   Spain
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2016/01/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   75   Years
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Additional Inclusion Criteria

- Patients suffering from knee pain, at least more than 3 month
- Patients taking German or Spanish
- pain intensity > 4 on the VAS

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Exclusion Criteria

- knee surgery less than one year
- rupture of knee ligaments less than 6 month
- acute fractures which are a contraindication for Osteopathy
- neoplasms
- inflammation like arthritis
- pregnancy
- BMI > 40

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Praxis für Osteopathie
    • Mr.  Arndt  Westendorf 
    • C. Parres, 90
    • 07570  Arta (Mallorca)
    • Spain
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    • Akademie für Osteopathie e.V.
    • Mr.  Msc, D.O.  Florian  Schwerla 
    • Römerschanzweg 5
    • 82131  Gauting
    • Germany
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    • Praxis für Osteopathie
    • Mr.  Arndt  Westendorf 
    • C. Parrs 90
    • 07570  Arta (Mallorca)
    • Spain
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Sources of Monetary or Material Support

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    • Praxis für Osteopathie
    • Mr.  Arndt  Westendorf 
    • C. Parres 90
    • 07570  Arta (Mallorca)
    • Spain
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    •   0034 650447844
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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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.