Trial document




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  DRKS00016611

Trial Description

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Title

Function and dynamics of central and peripheral pain processing structures in healthy subjects and patients with chronic pain. (Part 1)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to assess adaption and function of pain processing structures after a reversible stimulation of pain receptors (capsaicin pain model) in healthy volunteers and patients with chronic pain. Thereby, new knowledge towards disease development should be gained. The perception of pain will be assessed via Quantitative Sensory Testing (QST), functional laser-Doppler-flowmetry (fLDF) and questionnaires.

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Brief Summary in Scientific Language

Chronic pain is an important health problem, a fifth of the European population is affected (Breivik et al. 2006). However, the efficacy of treatment is due to limited options restrained (Kissin, 2010). In order to develop new analgetics a better understanding of chronic pain conditions is required. In fact, especially the knowledge of the dynamics in pain processing structures is limited.
Mechanisms involved in pain development can be structured in 3 phases, according to their underlying pathology (Woolf and Salter, 2000; Laird and Cervero, 1991). Phase 1 and 2 are characterized by a short-lasting activation of the nociceptive system or an inflammation mediated reversible modulation of peripheral and central sensitization processes (Koltzenburg et al., 1994). In contrast, degenerative and regenerative processes, which modify phenotype as well as genotype expressions are a prerequisite of phase 3.
In fact, not only a disease related change of gene expression, also specific genetic polymorphisms of pain processing structures may induce an altered pain perception (Binder et al., 2011). This observation was confirmed in healthy volunteers by inducing an experimental capsaicin pain model (Forstenpointner et al., 2017).

I. Hypotheses:
Genetic polymorphisms have an influence on dynamic and function of peripheral pain processing structures as well as nociceptor desensitization.

The understanding towards mechanisms of pain modulation after a peripheral nociceptor-sensitization is restrained. Therefore, the de- and regeneration capacity of C-fibers should be assessed via QST and fLDF. The advantage of the fLDF is that C-fiber function can be monitored directly via CGRP mediated microcirculation change. Additionally, a quantification of the endothelia-dependent (NO-mediated) component of the microcirculation is possible. A functional assessment of both systems could lead to a better understanding of the pathophysiological mechanism.

II. Hypotheses:

The nerve or endothelia dependent microcirculatory function in chronic pain patients is altered due to a modified nerve response. A reduced C-fiber function leads to a decreased blood perfusion change.

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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

  •   DRKS00016611
  •   2019/02/05
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  •   yes
  •   Approved
  •   D448/18, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   G60 -  Hereditary and idiopathic neuropathy
  •   G62 -  Other polyneuropathies
  •   M79.2 -  Neuralgia and neuritis, unspecified
  •   B02.2 -  Zoster with other nervous system involvement
  •   T14 -  Injury of unspecified body region
  •   T94 -  Sequelae of injuries involving multiple and unspecified body regions
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Interventions/Observational Groups

  •   A functional laser-Doppler-flowmetry will be conducted, in order to quantify functionality of vasoactive C-fibers.
    Further on Quantitative Sensory Testing, a blood analysis for SNPs (single nucleotid polymorphisms) as well as a pain evaluation within several questionnaires (NRS, painDetect, NPSI, PCS, PSQ, MPSS, HADS, SF-12) will be performed. 30 days after Capsaicin application the questionnaires NRS, painDetect, NPSI and SF-12 will be reevaluated as well as fLDF in a subgroup. Additionally, a telephone interview assessing general impression of change (PGIC, CGIC) will be conducted 2, 10, and 12 weeks after treatment.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

A functional laser-Doppler-flowmetry will be conducted, in order to quantify functionality of vasoactive C-fibers.

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Secondary Outcome

Further on Quantitative Sensory Testing, a blood analysis for SNPs (single nucleotid polymorphisms) as well as a pain evaluation within several questionnaires (NRS, painDetect, NPSI, PCS, PSQ, MPSS, HADS, SF-12) will be performed. 30 days after Capsaicin application the questionnaires NRS, painDetect, NPSI and SF-12 will be reevaluated as well as fLDF in a subgroup. Additionally, a telephone interview assessing general impression of change (PGIC, CGIC) will be conducted 2, 10, and 12 weeks after treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/04
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Healthy control group:
General inclusion criteria:
1. Healthy volunteers have to sign informed consent, whereby they confirm that they have been informed about the intent and purpose of the study.
2. Male or female > 18 years.
3. Study participants have to be able to describe and characterize localization and pain intensity and need to be able to complete all questionnaires within the study.
4. Eligibility of participants will be assessed by an screening test for healthy volunteers (Gierthmuhlen et al., 2015)
Study specific inclusion criteria: 5. No pain disorder in the medical history.

Patient group:
General inclusion criteria:
1. Patients have to sign informed consent, whereby they confirm that they have been informed about the intent and purpose of the study.
2. Male or female > 18 years.
3. Study participants have to be able to describe and characterize localization and pain intensity and need to be able to complete all questionnaires within the study.
4. Patients with chronic pain disorders.


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Exclusion Criteria

Healthy control group:

General exclusion criteria:
1. Previous alcohol, drug or medicine abuse or reasonable suspicion.
2. Other disease altering pain perception or immunological processes.
3. Known immunodeficiency or pregnancy


Patient group:

General exclusion criteria:
1. Previous alcohol, drug or medicine abuse or reasonable suspicion.
2. Other disease altering pain perception or immunological processes.
3. Known immunodeficiency or pregnancy

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Addresses

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    • Sektion für Neurologische Schmerzforschung und Therapie, Klinik für Neurologie, UKSH Campus Kiel
    • Mr.  Prof. Dr. med.  Ralf  Baron 
    • Arnold-Heller Str. 3
    • 24105  Kiel
    • Germany
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    •   0431 500 23911
    •   0431 500 23911
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    • Sektion für Neurologische Schmerzforschung und Therapie, Klinik für Neurologie, UKSH Campus Kiel
    • Mr.  Prof. Dr. med.  Ralf  Baron 
    • Arnold-Heller Str. 3
    • 24105  Kiel
    • Germany
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    • Sektion für Neurologische Schmerzforschung und Therapie, Klinik für Neurologie, UKSH Campus Kiel
    • Ms.  Julia  Forstenpointner 
    • Arnold-Heller Str. 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Grünenthal GmbH
    • Zieglerstr. 6
    • 52078  Aachen
    • Germany
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    •   0241 5690
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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