Trial document





This trial has been registered retrospectively.
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  DRKS00005954

Trial Description

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Title

The role of the endocannabinoidsystem and the immune system in chronic pain - alterations in comparison to healthy volunteers and influence of pain treatment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Chronic pain is a wide spread problem associated with impairment of qualitiy of life and the ability to work. The reason of the fact that some patients suffering from pain recover very quickly while others develop a chronic pain syndrome, ist not yet unterstood.
The present study investigates the role of the endocannabinoidsystem and the immune system (i.e. T-cell-system, pro- and antiinflammatory parameters such as cytokines) in patients with different pain syndromes in comparison to healthy volunteers. In addition, the influence of pain treatment including multimodal approaches and specific relaxation techniques on these parameters as well as on pain and on psychological well being is assessed.

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Brief Summary in Scientific Language

The aim of this study is to determine the endocannabinoid- and immune system in patients with chronic pain.

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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

  •   DRKS00005954
  •   2014/03/12
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  •   yes
  •   Approved
  •   331-10, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   R52.2 -  Other chronic pain
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Interventions/Observational Groups

  •   The aim of this study is to determine the endocannabinoid- and immune system in patients with chronic pain. All patients will receive study-independent standard treatment of the corresponding pain syndrome. There will be blood sampling at the beginning and after implementation of therapy.
  •   Healthy volunteers: There will be done one blood sampling and no treatment or intervention.
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Characteristics

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

Before and after standard treatment: Pain level: NRS, Stresslevel: KAB, Cytokines: Immunassay, Endocannabinoids: Mass-spektrometry, T cells: Flow cytometry, mRNA-expression: RT-PCR

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Secondary Outcome

Influences of routine standard pain treatment on the primary outcome parameters.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/09/02
  •   125
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Patients with chronic nociceptive and/or neuropathic pain without medication or stable medication for at least 14 days

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Exclusion Criteria

Pregnancy, psychological/mental disorder, addiction, glucocorticoid treatment

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Addresses

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    • Interdisziplinäre Schmerzambulanz und Tageskinik, LMU München, Klinikum Großhadern
    • Ms.  Prof. Dr. med.  Shahnaz Christina  Azad 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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    • Interdisziplinäre Schmerzambulanz und Tageskinik, LMU München, Klinikum Großhadern
    • Ms.  Prof. Dr. med.  Shahnaz Christina  Azad 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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    • Interdisziplinäre Schmerzambulanz und Tageskinik, LMU München, Klinikum Großhadern
    • Ms.  Prof. Dr. med.  Shahnaz Christina  Azad 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäre Schmerzambulanz und Tagesklinik der LMU München
    • Ms.  Prof. Dr. med.  Shahnaz Christina  Azad 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
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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.