Trial document




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  DRKS00015252

Trial Description

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Title

Cross-cultural adaptation and psychometric validation of the German version of the Central Sensitization Inventory (CSI-Ge)

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Trial Acronym

CSI-Ge

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URL of the Trial

https://www.pridedallas.com/questionnaires/

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Brief Summary in Lay Language

In this trial, the German version of the ‘Central Sensitization Inventory’ (CSI) for patients with chronic pain will be examined.
The term 'central sensitization' describes processes in the pain processing system (central nervous system, the brain and the spinal cord) of the body, which moght increase pain sensitivity. As a result, specific touch, body positions, or movements, which are normally not painful, become painful. Moreover, pain might spread to several regions of the body. The CSI questionnaire was developed to provide evidence of central sensitization within the diagnostic process.
The questionnaire was developed in English and is used worldwide already. Following a specific procedure, the original version was translated into German and has already been tested with patients for comprehensiveness. In a further step, psychometric properties of the German version will be validated, namely validity and reliability. For this study, patients with chronic pain as well as pain-free persons will be asked to complete the questionnaire describd above and a series of other questionnaires. The answers will be analyzed statistically.
If the German version proves to be valid and reliable, the questionnaire could be used for the diagnosis of patients with chronic pain. If evidence of 'central sensitization' can be determined from the questionnaire, further specific diagnostic and therapeutic actions could be initiated in earlier stages of the treatment.

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Brief Summary in Scientific Language

In this trial an authorized cross-cultural adaptation of the German version of the ‚Central Sensitization Inventory‘ (CSI-Ge) will be validated. The original version of the questionnaire was developed in the USA and was designed as a screening-tool for clinical practice, in order to determine certain somatic and emotional conditions that are often associated with central sensitization. In this study, ‘central sensitization’ (CS) is used as an umbrella term, which includes a variety of pain mechanisms at the spinal and supraspinal level.
The items of the original English version were generated by an interdisciplinary expert group in terms of chronic pain. The questionnaire was tested for test-retest reliability and internal consistency in the USA. By now, validation studies are available in different countries for patient groups with various medical conditions.
There is no validated version of the questionnaire in German. Therefore, this project will validate the German version of the ‘Central Sensitization Inventory’ (CSI-Ge). In preparation for this study the original English version was translated into German; the forward-backward translation procedure followed a standardized procedure (Beaton et al., 2000). Details about the translation procedure were published (Laekeman et al., 2017). Moreover, a cognitive pretest has already been finished. This study will examine psychometric properties of the German version, namely validity and reliability.
The CSI-Ge questionnaire could provide evidence of a manifest central sensitization in affected people in order to initiate specific diagnostic and therapeutic actions at an early stage of the treatment. Based on the CSI-score, central sensitization symptoms could moreover be graded into five degrees of severity (Neblett et al,. 2017).

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Organizational Data

  •   DRKS00015252
  •   2019/01/24
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  •   yes
  •   Approved
  •   15/9/17, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   R52 -  Pain, not elsewhere classified
  •   M54 -  Dorsalgia
  •   F45 -  Somatoform disorders
  •   R10 -  Abdominal and pelvic pain
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Interventions/Observational Groups

  •   Patients (n=250) with chronic pain: completing questionnaires (see below), in a subsample retest after 2-4 weeks.
    Instruments applied/parts of:
    German Pain Questionnaire (DGSS, 2015); PainDETECT questionnaire; Pain Sensitivity Questionnaire (PSQ); Somatization-Scale (PHQ-15) of the Patient Health Questionnaire (PHQ-D); Pain Catastrophizing Scale (PCS); Schmerzbeschreibungs-Liste (SBL) comprising qualitative pain characteristics.
  •   Control group (n=50) without current pain symptoms or current medical treatment because of chronic pain: completing questionnaires (see arm 1).
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Characteristics

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

Psychometric properties of the German version of the ‘CSI-Ge’ based on:
1) Reliability: Internal consistency (Cronbach’s Alpha) and retest reliability (intraclass correlation coefficient, time span: 2 weeks).
2) Validity: structural validity (explorative factor analysis); criterion validity (correlation with pain- and cognition-related questionnaires); Hypothesis-testing (patients with chronic pain achieve significantly higher CSI values compared to healthy control group).

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Secondary Outcome

Not applicable.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/01/25
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Chronic pain >= 3 months;
Sufficient physical and cognitive capacity to complete the questionnaires;
Sufficient knowledge of the German language to complete the questionnaires;

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Exclusion Criteria

Underlying psychatric disease with pain as predominant symptom (e.g. pure somatoform disorder, severe depression);
Patients at the beginning of a drug therapy of an underlying inflammatory disease;

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Addresses

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    • Klinik für Anästhesiologie, Universitätsmedizin Göttingen
    • Mr.  Prof. Dr. med.  Frank  Petzke 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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    • Hochschule für Angewandte Wissenschaft und Kunst, Hildesheim
    • Mr.  Prof. Dr.  Axel  Schäfer 
    • 31134  Hildesheim
    • Germany
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    • Hochschule Furtwangen
    • Ms.  Prof. Dr.  Angela V.  Dieterich 
    • 79100  Freiburg
    • Germany
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    • Abteilung für Allgemeinmedizin, präventive und rehabilitative Medizin; Philipps-Universität Marburg
    • Ms.  M.Sc.  Katrin  Kuss 
    • 35032  Marburg
    • Germany
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    • Physiologische Psychologie, Universität Bamberg;
    • Ms.  Marjan  Laekeman, M.Sc. 
    • Zillertalstr. 120;
    • 44807  Bochum
    • Germany
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    • Klinik für Anästhesiologie, Universitätsmedizin Göttingen
    • Mr.  Prof. Dr. med.  Frank  Petzke 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • DVMT - Deutscher Verband für manuelle Therapie (Maitland® Konzept) e.V.
    • c/o Collenbuschstraße 16
    • 01324  Dresden
    • Germany
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    •   0351-20878414
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Status

  •   Recruiting planned
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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.