Trial document





This trial has been registered retrospectively.
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  DRKS00005735

Trial Description

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Title

FAUL (Fascia and Lymph Trial (German: Fascia and Lymph)): Fascial techniques combined with manual lymphatic drainage/Complex Physical Therapy for Lymphedema of the limbs, measured by volume reduction of the edema.

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Trial Acronym

FAUL-Study

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URL of the Trial

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Brief Summary in Lay Language

This trial serves to demonstrate the effects of fascial techniques paired with manual lymphatic drainage in patients with exhibiting lymphedema. Results will be measured by examining the scale of volume reduction. Beneficial effects are expected to include improved evacuation of the lymph and, consequently enhanced volume reduction in arms or legs. Participants are randomly assigned to three different trial groups. The first trial group receives the common treatment of manual lymphatic drainage and elastic compression, as per usual. The second trial group receives an additional treatment with fascial techniques prior to the manual lymphatic drainage session. The third trial group also receives additional treatment with.
A division of trial participants into three groups serves the purpose of efficient data evaluation, allowing us to determine if a combination of fascial techniques with manual lymphatic drainage is effective at all, and, if so, to investigate if it is superior to a regular treatment consisting of manual lymphatic drainge only.

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Brief Summary in Scientific Language

Hypothesis:
1-H0: A mobilization of the fascial techniques in combination with manual lymphatic drainage (MLD) and elastic compression (EC) has no significant influence on the volume reduction in a lymphedema of the upper limbs.
1-H1: A mobilization of the fascial techniques in combination with MLD/EC has a significant influence on the volume reduction in a lymphedema of the upper limbs.
2-H0: A mobilization of the fascial techniques in combination with MLD/EC has no significant influence on the volume reduction in a lymphedema of the lower limbs.
2-H1: A mobilization of the fascial techniques in combination with MLD/EC has a significant influence on the volume reduction in a lymphedema of the lower limbs.

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Organizational Data

  •   DRKS00005735
  •   2014/04/17
  •   [---]*
  •   yes
  •   Approved
  •   13-003, Ethikkommission der Steinbeis Universität Berlin
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Secondary IDs

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

  •   I89.0 -  Lymphoedema, not elsewhere classified
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Interventions/Observational Groups

  •   Application of fascial techniques prior to manual lymph drainage treatment with elastic compression; 1-2 x per day, 5 days of therapy each week, for a time span of 3-4 weeks.
  •   Application of fascial techniques after manual lymph drainage treatment with elastic compression; 1-2 x per day, 5 days of therapy each week, for a time span of 3-4 weeks.
  •   Application of manual lymph drainage treatment and elastic compression; 1-2 x per day, 5 days of therapy each week, for a time span of 3-4 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Volume reduction determined through precision volumetric measurement (Perometer) of the affected limbs both upon commencement and completion of the 3-4 week trail period.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/21
  •   400
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

All types of lymphedema of the limbs in males and females of age.
- Primary lymphedema
- Secondary lymphedema
- Generalized lymphedema
- Lipolymphedema

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Exclusion Criteria

- cardiac edema with decompensated, right-heart failure
- bacterial inflammation - Erysipelas
- Disease, which are contraindications to the treatment of manual lymph drainage with elastic compression
- acute thrombophlebitis / phlebothrombosis
- readjustment of medication during participation in the trail, especially concerning medication influencing body water balance, such as antidiuretics.
- failure to obtain approval of a participant
- psychiatric conditions
- legally incapable patients
- acute trauma with or without immobilization of the affected limb
- pregnancy

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Addresses

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    • Praxis für Osteopathische Medizin In Kooperation mit oben genannten Kliniken
    • Ms.  Inge  Bez 
    • Manentalstr. 15
    • 72805  Lichtenstein
    • Germany
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    • Lympho-opt Klinik
    • Mr.  Dr  Franz-Josef  Schingale 
    • Happburger Str. 15
    • 91224  Hohenstadt/Pommelsbrunn
    • Germany
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    • Baumrainklinik, Haus am Schlosspark
    • Mr.  Winfried  Schneider 
    • Hochstr. 7
    • 57319  Bad Berleburg
    • Germany
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    • Praxis für Osteopathische Medizin
    • Ms.  Inge  Bez 
    • Manentalstr. 15
    • 72805  Lichtenstein
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Praxis für Osteopathische Medizin
    • Ms.  Inge  Bez 
    • Manentalstr. 15
    • 72805  Lichtenstein
    • Germany
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Sources of Monetary or Material Support

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    • Praxis für Osteopathische Medizin
    • Ms.  Inge  Bez 
    • Manentalstr. 15
    • 72805  Lichtenstein
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/17
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Trial Publications, Results and other Documents

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