Trial document





This trial has been registered retrospectively.
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  DRKS00006280

Trial Description

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Title

Osteopathic treatment of women with persistent low back pain postpartum. 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

Low back pain (LBP) is a common complaint amongst women during and after pregnancy with a great impact on their quality of life. In this study the effectiveness of osteopathic treatments in women suffering from LBP after childbirth will be investigated. 80 women with LBP postpartum are randomly assigned to a treatment group and an untreated group. The question should be evaluated if pain and disability in daily life by four osteopathic treatments can be reduced.

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Brief Summary in Scientific Language

The aim of this study is to evaluate the perceived effectiveness of an osteopathic treatment in a randomized controlled trial of women suffering from pregnancy-related low back pain. The focus here in this study should carry out the problems postpartum. Outcome parameters investigated were the perceived pain and disabilities of daily life.

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Organizational Data

  •   DRKS00006280
  •   2014/07/01
  •   [---]*
  •   yes
  •   Approved
  •   EKO01, Ethikkommission für Osteopathie (EKO), Römerschanzweg 5, 82131 Gauting, Deutschland, www.osteopathie-akademie.de
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Secondary IDs

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

  •   non-specific low back pain postpartum
  •   M54.5 -  Low back pain
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Interventions/Observational Groups

  •   The patients in the intervention group will be treated with osteopathy. The treatment is diagnosis-oriented according to the basic principles of osteopathy in the parietal, visceral and cranial system. Four treatments at intervals of 2 weeks will be conducted. 12 weeks after the end of treatments a follow-up will be carried out.
  •   The patients in the control group stay untreated (waiting list)
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Characteristics

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

pain intensity (Visual analoque scale), activities of daily life (Oswestry questionnaire)
before each treatment

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Secondary Outcome

osteopathic dysfunktions (questionnaire)
before first treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2010/01/20
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   42   Years
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Additional Inclusion Criteria

women aged 18-42,
delivery 3-15 months ago,
> 3 months non specific low back pain (LBP),
intensity LBP >5 on VAS,
after gynecological examination,

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Exclusion Criteria

LBP before pregnancy,
other therapies, use of analgesics,
severe traumata, skeletel injury, fractures,
osteoarthritis, neurological disorders,
chronic inflammatory disorders,
neoplasm, metastases, osteoporosis

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Addresses

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    • Praxis für Osteopathie
    • Denis und Katrin  Rother 
    • Schuhmannstr. 11
    • 76185  Karlsruhe
    • Germany
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    • Akademie für osteopathie e.V.
    • MSc, D.O.  Florian  Schwerla 
    • Römerschanzweg 5
    • 82131  Gauting
    • Germany
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    • Praxis für Osteopathie
    • Denis und Katrin  Rother 
    • Schuhmannstr. 11
    • 76185  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Praxis für Osteopathie
    • Denis und Katrin  Rother 
    • Schuhmannstr. 11
    • 76185  Karlsruhe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/01
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Trial Publications, Results and other Documents

  •   Schwerla F, Rother K, Rother D, Ruetz M, Resch KL. Osteopathic Manipulative Therapy in Women With Postpartum Low Back Pain and Disability: A Pragmatic Randomized Controlled Trial. J Am Osteopath Assoc. 2015 Jul 1;115(7):416-25.
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* This entry means the parameter is not applicable or has not been set.