Trial document





This trial has been registered retrospectively.
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  DRKS00008964

Trial Description

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Title

Non-coding RNAs in neurogenic and neuropathic pain mechanisms and their application for risk assessment, patient stratification and
personalised pain medicine

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Trial Acronym

ncRNAPain

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URL of the Trial

http://www.ncrna-pain.eu/

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Brief Summary in Lay Language

Chronic pain syndromes which develop after nerve damage, trauma, or surgery are characterized by persistent and severe pain. They induce anxiety and depression and greatly impair patients’ quality of life. One out of five Europeans suffer from chronic pain, many of them for more than two years, some even longer. Chronic pain therefore constitutes not only a heavy burden for individual patients and their families, but also for national health systems in Europe since treatment costs take up 1.5 to 3 % of their gross domestic product (GDP) per year.
The ncRNAPain project sets out to further explore the biological mechanisms underlying chronic pain. The project aims at decoding these biological molecules’ role, which perform multiple vital roles in our genetic make-up and in the generation of chronic pain syndromes. The project is designed to deepen scientific knowledge on how pain is generated, propagated, and eased.

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Brief Summary in Scientific Language

Neuro-immune alterations in the peripheral and central nervous system play a role in the pathophysiology of chronic pain, and non-coding RNAs (ncRNAs) regulate both immune and neuronal processes. Therefore, ncRNAPain proposes that ncRNAs are critically important master switches for chronic pain. ncRNAPain represents a multidisciplinary consortium of clinical partners, molecular and systems-level neuroscientists, bioinformatics and ncRNA experts. In order to gain knowledge on the mechanisms of chronic pain, ncRNAPain will investigate ncRNAs specifically in neurogenic and neuropathic pain, including headache. ncRNAPain will provide novel understanding of ncRNA regulation of processes modulating nociception and endogenous analgesia and of the importance of ncRNAs in circuitries and cognitive, emotional and behavioural components of pain. ncRNAPain will reveal insights into the concerted function of ncRNAs in the control of macromolecular complexes in neurons, glia and immune cells and signals used for neuroimmune communication in the pain pathway. Based on these findings, ncRNAPain will identify and validate specific ncRNAs as new druggable molecular targets for pain prevention and relief. ncRNAPain will identify pain predisposing ncRNA expression patterns and polymorphisms in ncRNAS and/or their binding sites as biomarkers for pain and inter-individual variations in the response to painful stimuli and analgesic drugs.

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Organizational Data

  •   DRKS00008964
  •   2015/08/05
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  •   yes
  •   Approved
  •   837.457.13 (9142-F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   complex regional pain syndrome
    (CRPS); ICD 10 M89.0
  •   diabetic neuropathies (dPNP),ICD 10 G63.2
  •   nerve lesions (NL); ICD 10 G58.9
  •   M89.0 -  Algoneurodystrophy
  •   G63.2 -  Diabetic polyneuropathy
  •   G58.9 -  Mononeuropathy, unspecified
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Interventions/Observational Groups

  •   painful dPNP patients
    drawing blood and clinical neurophysiologic investigation
  •   non-pain dPNP patients
    drawing blood and clinical neurophysiologic investigation
  •   posttraumatic CRPS patients
    drawing blood and clinical neurophysiologic investigation
  •   post fracture patients without CRPS
    drawing blood and clinical neurophysiologic investigation
  •   patients with painful nerve lesion
    drawing blood and clinical neurophysiologic investigation
  •   patients with painless nerve lesion
    drawing blood and clinical neurophysiologic investigation
  •   healthy subjects
    drawing blood and clinical neurophysiologic investigation
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is to explore the role of ncRNA in chronic pain. Patients data will be explored, the results will be translated into rodent pain models and then backtranslated (confirmed) into patients.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Czech Republic
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/01
  •   1375
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients have to suffer from the diseases of interest. Therefore, patients have to meet minimum diagnostic criteria for
CRPS, PNP, nerve lesions, headaches

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Exclusion Criteria

patients suffering from tumors, acute infection or autoimmune diseases; pregnancy / lactation.
Other diseases are registered; but will not prevent patients from participating in the study. This is also applicable for affective disorders. Control subject shall not suffer from any pain disorder, including CRPS, PNP, headaches, as well as traumatic nerve lesions.
Patients with pregnancy, breast feeding period or with doubts about compliance will be not included.

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Addresses

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    • European Comission, Directorate - General for Research and Innovationl
    • F2
    • 1049  Brüssel
    • Belgium
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    • Klinik und Poliklinik für Neurologieder Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Prof.  Frank  Birklein 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Neurologie der Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Prof.  Frank  Birklein 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Die Studie ist Teil eines europäischen Konsortiums, das im Rahmen des 7. Forschungsrahmenprogramms von der EU gefördert wird. Directorate - General for Research and Innovation
    • F2
    • 1049  Brüssel
    • Belgium
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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.