Trial document




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  DRKS00012426

Trial Description

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Title

Clinical-practical validity of vegetative rhythms in peripheral physiological signals

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Trial Acronym

[---]*

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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

Intra- and interindividual peripheral physiological signals of vegetative rhythms in osteopathic approach in adult patients in osteopathic practices.

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Organizational Data

  •   DRKS00012426
  •   2017/05/09
  •   [---]*
  •   yes
  •   Approved
  •   07/2017, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   F45 -  Somatoform disorders
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Interventions/Observational Groups

  •   Parallel measurements of peripheral physiological signals and rhythms (ECG, rhythm of breathing, skin resistance, muscle activity, etc.) to the examination of intra - and inter-individual case the therapists and patients, the signals during an osteopathic treatment and assessment of effectiveness (based on questionnaires) with regard to the quantity of synchronization of the rhythms.
  •   Parasympathetic nervous system activation (without osteopathic treatment)
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Is there a valid synchronization of physiological signals between patient and therapist in Osteopathic treatments and if, how effective it is?

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Secondary Outcome

HADS, SOC, PHQ-D, ICR-ICD10 Symptom rating, IES-R Impact Scale revised form,
Each before 1 st physiological measurement and after 2.4.6 weeks at control

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2018/01/02
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Somatoform, psychosomatic and functional disorders and pain syndromes

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Exclusion Criteria

Absence of consent, minority, non-working persons, morphine medication, psychotropic medication, basic psychiatric disorders

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Addresses

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    • Hochschule für Gesundheitsorientierte Wissenschaften Rheinneckar, HGWR gGmbH
    • Mr.  Dr. med.  Holger  Pelz 
    • Belchenstr. 1-5
    • 68163  Mannheim
    • Germany
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    • Simplana
    • Mr.  Dr.  Volker  Perlitz 
    • Neuenhoferweg 25
    • 52074  Aachen
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Hochschule für Gesundheitsorientierte Wissenschaften Rheinneckar, HGWR gGmbH
    • Mr.  Dr. med.  Holger  Pelz 
    • Belchenstr. 1-5
    • 68163  Mannheim
    • 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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    • Hochschule für Gesundheitsorientierte Wissenschaften Rheinneckar, HGWR gGmbH
    • Mr.  Dr. med.  Holger  Pelz 
    • Belchenstr. 1-5
    • 68163  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Head-Genuit-Stiftung, HGS
    • Postfach 3340
    • 52120  Herzogenrath
    • Germany
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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.