Trial document




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  DRKS00017685

Trial Description

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Title

Long-term effects of multimodal pain therapy

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Trial Acronym

MMT Longterm

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Interdisciplinary multimodal pain therapy is based on the bio-psychosocial pain model and has been established in the treatment of chronic pain in recent years.
With the present study, it shall be examined whether, respectively, to which extent there are effects of multimodal pain therapy beyond a time interval of one year after therapy.
For the study, all patients, who had been treated in the Interdisciplinary Pain Center, (University Hospital Freiburg) with a multimodal pain therapy of at least four weeks duration within a timeframe of six years are eligible.
With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status. The data shall be compared to data prior to treatment taken from the patient’s charts.
With this study, it should be elucidated whether there is a long term therapeutic effect. Moreover, possible prognostic factors for the long-term effects should be identified.

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Brief Summary in Scientific Language

Interdisciplinary multimodal pain therapy is based on the bio-psychosocial pain model and has been established in the treatment of chronic pain in recent years. The efficiency of multimodal pain therapy has been shown in a variety of studies. Systematic reviews showed that regarding pain reduction, the effect sizes of multimodal pain therapy are relatively modest. Larger effect sizes can be reached regarding functionality, and particularly regarding the return to work rate.
To date there are only few long term observations with a follow-up of more than one year after multimodal pain therapy. Most studies on multimodal pain therapy do not examine intervals of more than one year after therapy. Already within this timeframe, in some studies, a reduction of the effects induced by multimodal pain therapy was observed.
With the present study, it shall be examined whether respectively, to which extent there are effects of multimodal pain therapy beyond a time interval of one year after therapy.
For the study, all patients, who had been treated in the Interdisciplinary Pain Center, (University Hospital Freiburg) with a multimodal pain therapy of at least four weeks duration within a timeframe of six years are eligible.
With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status. The data shall be compared to data prior to treatment taken from the patient’s charts.
With this study, it should be elucidated whether there is a long term therapeutic effect. Moreover, possible prognostic factors for the long-term effects should be identified.

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Organizational Data

  •   DRKS00017685
  •   2019/08/07
  •   [---]*
  •   yes
  •   Approved
  •   517/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   With a questionnaire, data on pain scores (mean, lowest and highest pain score during the preceding two weeks, pain score regarded as a bearable), depression, anxiety, stress, pain related disability and the current employment status.
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Characteristics

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

Mean, highest, lowest and acceptable pain strength on the NRS (numerical rating scale) at time of follow-up

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Secondary Outcome

Depression/anxiety/stress, quality of life, pain related invalidity, employment status

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/07/21
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Day hospital multimodal pain therapy in the ISZ between 1.1.2013 and 31.12.2018.

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Exclusion Criteria

Incompleteness of questionnaire, severe psychiatric comorbidity, missing language skills to understand questionnaire

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Addresses

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    • Interdisziplinäres Schmerzzentrum Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Tilman  Wolter 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • 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.