Trial document




drksid header

  DRKS00023163

Trial Description

start of 1:1-Block title

Title

Perceived Injustice in Chronic Pain

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Perceived Injustice

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Chronic pain, particularly chronic pain secondary to trauma, often goes along with the feeling of perceived injustice.
The aim of the present study is to assess, which factors go along with perceived in justice and how this feeling is distributed among patients with different diagnosis, different ages or differing lengths of their pain history. Moreover, it shall be assessed how and perceived injustice can be influenced by means of the multimodal pain therapy or other pain therapies.
With the IEQ (Injustice Experience Questionnaire) which was developed in the 2008 perceived injustice can be assessed in a standardised manner.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Chronic pain, particularly chronic pain secondary to trauma, often goes along with the feeling of perceived injustice. With the IEQ (Injustice Experience Questionnaire) which was developed in the 2008 perceived injustice can be assessed in a standardised manner. Studies show that a strong feeling of injustice often goes along with the delayed rehabilitation, a problematic development of the pain and is often related to pain catastrophizing. The IEQ has been validated in different languages and recently also a German version has been published.
The aim of the present study is to assess, which factors go along with perceived in justice and how this feeling is distributed among patients with different diagnosis, different ages or differing lengths of their pain anamnesis. Moreover, it shall be assessed how and perceived injustice can be influenced by means of the multimodal pain therapy or other algesiologic interventions.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

The anonymised raw data will be published as supplementary data.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00023163
  •   2020/10/08
  •   [---]*
  •   yes
  •   Approved
  •   20-1061, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Chronic pain
  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with chronic pain fill in the IEQ
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

What: Perceived Injustice, how: Injustice Experience Questionnaire, when: once (in a subgroup of patients who later have multimodal pain therapy a second time ater therapy)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

what (how): depression/anxiety/stress (Depressions/Angst Stress Skala, DASS), quality of life (Habitual Well-Being Questionnaire (FW-7), pain related disability (Pain Disability Index, PDI), occupation status (patient charts)
hen: once (in a subgroup of patients who later have multimodal pain therapy a second time ater therapy)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/10/01
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

age 18-80 years, day hospital treatment between 10/01/2020 and 12/31/2020

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

incompleteness of the questionnaire, language or intellectual incapacity to understand the questionnaire

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Interdisziplinäres Schmerzzentrum UKL Freiburg
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
  •   [---]*
  •   [---]*
  •   164
  •   164
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.