Trial document




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  DRKS00003123

Trial Description

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Title

Transition from localized low back pain to chronic widespread pain in general practice: Identification of risk factors, preventive factors, and key elements for treatment.

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Trial Acronym

[---]*

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URL of the Trial

http://www.login-verbund.de/index.php?id=15

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Brief Summary in Lay Language

Long running low back pain can widespread arround the whole body. The name is chronic widespread pain. At the moment, informations about frequency of chonic widespread pain in primary setting does not exist. That question will be answered by this study. Although the study will find prognostic factors protecting chronic widespread pain and how influencing them.

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Brief Summary in Scientific Language

The aim of the study is to identify predictors of pain generalization in consulters for low back pain in general practice and to identify individual resources for the prevention of the transition from chronic localized LBP to chronic widespread pain (CWP). These results provide the psychological background information on CWP patients which can be used for an intervention addressing resources and risk factors of this patient group.

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Organizational Data

  •   DRKS00003123
  •   2011/06/28
  •   [---]*
  •   yes
  •   Approved
  •   88/10, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   chronic widespread pain,
  •   M54.8 -  Other dorsalgia
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Interventions/Observational Groups

  •   Patients with chronic local low back pain during point of time T0 will include in a cohort study and observed with regard of pain loacalisation.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   [---]*
  •   [---]*
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Primary Outcome

Primary endpoint: Propability getting a chronic widespread pain for patients with chronic local low back pain during one year. Measuring: questionnaires, every 3 months. The questionnaire constists of a body pain drawing (Pfau et al. 2009*) where patients drawing in their pain. The analysis will done by the definition of Wolfe et al 1999*.

* Pfau Doreen B. et al. Somatosensory profiles in subgroups of patients with myogenic
temporomandibular disorders and fibromyalgia syndrome. Pain. 147 (2009) 72–83.

* Wolfe et al.The american college of rheumatology 1999 criteria for the classification of fibromyalgie. Arthritis and Rheumatism, Vol. 33, No. 2 (February 1990).

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Secondary Outcome

prevalence of local chronic low back pain and prevalence of chronic widespread pain in primary care setting. Measurement: questionnaire, to point of time To.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/06/01
  •   1000
  •   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

all patients consulting their family doctor because of chronic* low back pain during a time of 4 month.
* chronic = pain during most days in the last three month.
** low back pain = Pain in the back area under the costal arch an over the bottum fold.+/- radiation.

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Exclusion Criteria

- lack of fluency
- age < 18 years
- pregnancy

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Addresses

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    • Philipps-Universität Marburg
    • Biegenstr. 10/12
    • 35037  Marburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Abteilung für Allgemeinmedizin, Präventive und Rehabilitative Medizin Philipps-Universität Marburg
    • Ms.  Prof. Dr.  Annette  Becker 
    • Karl-von-Frisch Str. 4
    • 35032  Marburg
    • Germany
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    • Abteilung für Allgemeinmedizin, Präventive und Rehabilitative Medizin Philipps-Universität Marburg
    • Ms.  Prof. Dr.  Annette  Becker 
    • Karl-von-Frisch Str. 4
    • 35032  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • 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.