Trial document





This trial has been registered retrospectively.
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  DRKS00000794

Trial Description

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Title

The use of a three dimensional untrasound-based measurement device for the evaluation of subjects with and without neckpain

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The objective of this study is to evaluate wheater neckpain can be detected by altered motion patterns. Motions analysis will be done by ultrasound. If this device can be validated part of the patients with neckpain may be prevented from x-ray exposítion in future. For that purpose movemnet+ characteristics of healthy subjects will be compared to those of Patientes with neck pain as a first step.

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Brief Summary in Scientific Language

The purpose of the study is to compare movement characteristic of healthy subjects to those of patients with acute and chronic neck pain. By analyziing velocity and acceleration typical movement pattern of subjects with and without neckpain will be identified and compared to validated clinical tests, x-rays and psychosocial varaibles.

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Organizational Data

  •   DRKS00000794
  •   2011/04/08
  •   [---]*
  •   yes
  •   Approved
  •   40/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   M54.2 -  Cervicalgia
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Motions patterns of healthy subjects will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires
  •   Motions patterns of patients with acute neck pain will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires
  •   Motions patterns of patients with chronic neck pain will be analyzed by means of ultrasound topometry. Clinical and manual tests for mobility and pain provocation will be performed, psychosocial factors will be evaluated by questionnaires
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Single blind
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Motion patterns (velocity and acceleration) are investigated by means of ultrasound topometry. Prímary endpoints are peaks within the acceleration curve, for which an analysis of frequency will be performed.

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Secondary Outcome

Data from physical and psychological evaluation from validated quationnaires for mobility, pain, disability, anxiety, depression, fear-avoidance-beliefs. quality of life.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/04/22
  •   180
  •   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

Patients with neck pain and subjects without pain and symptoms during the last 12 months and without medical interventions for neck pain during the last 5 years.

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Exclusion Criteria

Any conditions where active movement may harm the patient irre-versibly or severely, mental dísorders (except anxiety and depression), severe nerve root or spinal cord compression with neurological signs, Neurological symptoms during cervical movements, Vertigo , Patients with running lawsuit where neck pain plays a role, Patients aiming at retirement

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Philipps-Universität Marburg Fachbereich Medizin Physiotherapie
    • Mr.  M.Sc.Phys.  Udo  Wolf 
    • Baldinger Strasse 1
    • 35032  Marburg
    • Germany
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    • Philipps-Universität Marburg Fachbereich Medizin Physiotherapie
    • Mr.  M.Sc.Phys.  Udo  Wolf 
    • Baldinger Strasse 1
    • 35032  Marburg
    • Germany
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    • Philipps-Universität Marburg Fachbereoich Medizin Physiotherapie
    • Mr.  M.Sc.Phys.  Udo  Wolf 
    • Baldfnger Strasse 1
    • 35032  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg Fachbereich Medizin Physiotherapie
    • Mr.  M.Sc.Phys.  Udo  Wolf 
    • Baldinger Srrasse 1
    • 35032  Marburg
    • 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.