Trial document




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  DRKS00006322

Trial Description

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Title

Inter-rater-reliability and reproducibility of measurements of reflex points in the neck as diagnostic tool within neuraltherapy

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Trial Acronym

NRP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within neuraltherapy the measurement of so called reflex points in the neck can be significantly involved in therapeutic plans. The aim of the current trial is to investigate whether different diagnosticians detect the same points in the same patient. Furthermore, possible changes in the points due to neuraltherapy is evaluated.
Study participants are inpatients at the Clinic for Integrative Medicine, Essen.

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Brief Summary in Scientific Language

The measurement of reflex points in the neck can significantly contribute to neuraltherapeutic plans. The diagnostic measurements are not validated, yet.
The aim of the current study is to investigate the inter-rater-reliability and reproducibility of measurements of different diagnosticians as well as the congruence between patients' and diagnosticians' evaluation. In a subgroup of patients treated with neuraltherapy, it will be evaluated, if the points are affected by treatment.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006322
  •   2014/07/10
  •   [---]*
  •   yes
  •   Approved
  •   13-5683-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   inpatients of the clinic, no specific disease
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Interventions/Observational Groups

  •   usual care neuraltherapy in accordance to diagnosis

    determination of 8 standardised reflex points in the neck by 5 diagnosticians' before and after neuraltherapy

    individualized neuraltherapy
  •   non-treated control

    determination of 8 standardised reflex points in the neck by 5 diagnosticians
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   No treatment
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

outcome:
correlation between 5 diagnosticians' evaluations

timepoints:
ratings of the first and second examination

instrument:
categoric rating scale

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Secondary Outcome

- overlap between diagnosticians' and patients' evaluation concerning the reflec points in the neck (sensitivity and specifity)
- correlation between first and second evaluation for each diagnostician (palpations)
- change in detectability of points after neuraltherapy (patients' and diagnosticians' evaluation)
- correlation between symptom severity and change in neck reflex points

(categoric rating scales)


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/07/11
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- age > 18 years
- sufficient knowledge of German language
- written informed consent
- inpatient status at our clinic

additonally for subgroup of patients treated with neuraltherapy:
neuraltherapy recommendation of treating physician during stay at our clinic

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Exclusion Criteria

- severe psychiatric diseases (e.g. schizophrenia),
- pregnancy
- systemic neurological diseases (multiple sclerosis, parkinson disease, dementia)
- contra-indications against neuraltherapy

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Addresses

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    • Universität Duisburg-Essen Lehrstuhl und Klinik für Naturheilkund und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Mr.  Prof. Dr. med.  Gustav  Dobos 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Universität Duisburg-Essen, Lehrstuhl und Klinik für Naturheilkunde und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Ms.  Dr.  Kyung-Eun  Choi 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Universität Duisburg-Essen, Lehrstuhl und Klinik für Naturheilkunde und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Ms.  Dr.  Kyung-Eun  Choi 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universität Duisburg-Essen Lehrstuhl und Klinik für Naturheilkund und Integrative Medizin, Knappschafts-Krankenhaus, Kliniken Essen-Mitte
    • Mr.  Prof. Dr. med.  Gustav  Dobos 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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