Trial document





This trial has been registered retrospectively.
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  DRKS00006876

Trial Description

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Title

Effect of psychoregulative massage therapy on pain and depression in patients with chronic and / or somatoform back pain. A randomized controlled trial.

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Trial Acronym

PMKMchS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The study examines two different massage forms with the background the care of chronichen pain patients to improve. It becomes the psychoregulierende massage (gentle whole body massage) with the classical massage therapy, defines after the valid remedy catalogue, compared. Hypothetical background: It should be tried to show that chronic pain patients with an easy series of treatment of 10 massages, come back faster in the activity of the everyday life.

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Organizational Data

  •   DRKS00006876
  •   2016/12/07
  •   [---]*
  •   yes
  •   Approved
  •   2014-148, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
  •   F45 -  Somatoform disorders
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Interventions/Observational Groups

  •   Psycho-regulate (gentle interacting massages concerning the creation parameters Pressure, Time, Rhythm and Direction) massage: The treatments take place 2 times per week, over a period of 5 weeks, duration of the meetings 60 minutes
  •   classical (swedish) The treatments take place 2 times per week, over a period of 5 weeks, duration of the meetings 20 minutes)
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Characteristics

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

Intensity of pain on the visual Analogously scale and pain dimensions (Hamburg pain adjective list = HSAL), as well as the degree of the Depression (BDI-II). In each case measured after 5 and 10 treatments, as well as after 3 months

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Secondary Outcome

Bodily functions, activities and participation of the patient measured with the Oswestry Disability index (ODI) after 5 and 10 treatments, as well as after 3 months and drug taking behaviour measured using a drug diary - evaluation period the first day to 3 months after ending of the intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/04/03
  •   66
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Back pain diagnosis according to ICD-10: M54-and F45-
* Back pain since more than 6 months
* Age 18-75 years
* Voluntary participation in the study
* Sufficient knowledge of the German language to understand the questionnaires

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Exclusion Criteria

* The possibility of the selfdecision to the participation is not given
* Inflammatory illnesses
* Open injuries of the skin
* A running pension procedure

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Martin-Luther-Universität Halle Wittenberg
    • Mr.  Prof. Dr.  Johann  Behrens 
    • Magdeburger Straße 16
    • 06112  Halle (Saale)
    • Germany
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    • Physiotherapie Praxis
    • Ms.  Bc., MSc.Phys.  Sabine  Baumgart 
    • Harburger Rathausstrasse 33
    • 21073  Hamburg
    • Germany
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    • Physiotherapie Praxis
    • Ms.  Sabine  Baumgart 
    • Harburger Rathausstrasse 33
    • 21073  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Physiotherapie am Rathaus, Harburger Rathausstraße 33, 21073 Hamburg
    • Ms.  M.Sc.Phys.  Sabine  Baumgart 
    • Harburger Rathausstraße 33
    • 21073  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.