Trial document




This trial has been registered retrospectively.
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  DRKS00022110

Trial Description

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Title

Patients with chronic pain prefer maintenance of pain treatment despite COVID-19 pandemic restrictions

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Trial Acronym

[---]*

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URL of the Trial

http://forschdb.verwaltung.uni-freiburg.de/servuni/forschdbuni.recherche0?xmldokumentart=Projekt&lfdnr=11889&sprache=D&Layout=uni&Ausgabeart=bs&Rahmen=1&CSS=https://forschdb.verwaltung.uni-freiburg.de/uni2002/content.css&Variante=3

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Brief Summary in Lay Language

In this prospective study, patients suffering from chronic pain treated at a large German interdisciplinary pain center were studied over a period of 2 months at the beginning of the pandemic. Data from patient charts and questionnaires were evaluated. Patients were asked about postponements or cancellations of pain therapy, the possible effect on pain levels, depression, anxiety and stress and the impact of intensified hygiene measures. Results were compared to those from standardized and validated questionnaires from the same patients (German version of the depression, anxiety and stress scale = DASS) at time of the first contact in the pain clinic.

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Brief Summary in Scientific Language

The aim of this prospective study is to clarify whether chronic pain patients are impaired in treatment by the hygiene measures caused by the pandemic.

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

Yes

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Description IPD sharing plan:

The anonymised study data will be published as supplementary data.

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Organizational Data

  •   DRKS00022110
  •   2020/12/21
  •   [---]*
  •   yes
  •   Approved
  •   353/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1262-4221 
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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

  •   Patients are interviewed using a questionnaire and telephone interview.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Other
  •   [---]*
  •   N/A
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Primary Outcome

Survey by means of a questionnaire and telephone interview

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Secondary Outcome

There is none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/06/15
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with chronic pain and treatment in the pain clinic during the COVID-19 pandemic

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Exclusion Criteria

younger than 18 years, inadequate German language skills

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Addresses

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    • Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg
    • Breisacherstrasse 117
    • 79106  Freiburg
    • Germany
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    •   [---]*
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    •   [---]*
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    • Interdisziplinäres SchmerzzentrumUniversitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg
    • Ms.  Dr. med., MSc.  Barbara  Kleinmann 
    • Breisacherstrasse 117
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres SchmerzzentrumUniversitätsklinikum FreiburgMedizinische Fakultät
    • Ms.  Dr.  Barbara  Kleinmann 
    • Breisacherstrasse 117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Medizinische Fakultät, Albert-Ludwigs-Universität Freiburg
    • Breisacherstrasse 117
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2020/10/30
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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.