Trial document




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  DRKS00009849

Trial Description

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Title

Effects of a multimodal pain therapy on neurotransmitter turnover and functional connectivity in patients with chronic back pain.

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Trial Acronym

EmPaTh-MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Recent studies revealed persistent changes in the brain of chronic pain patients. There are hints that the concentration of chemical messenger substances (so called neurotransmitter) is altered in the brain of chronic pain patients. Further, there is evidence for altered "communication patterns" between specific brain areas (so called functional connectivity) in chronic pain patients. In this study neurotransmitter concentrations and functional connectivity of chronic back pain patients will be compared to healthy controls to gain insight in the mechanisms of pain chronification. Further, neurochemical and functional changes after a multimodal pain therapy will be investigated. Endpoints will by measured by means of functional magnet resonance imaging (MRI) and MR-spectroscopy.

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Brief Summary in Scientific Language

The major aim of this study is to investigate alterations in neurotransmitter levels and functional brain connectivity in pain processing regions of the brain in patients with chronic back pain. Patients are recruited via a screening program of the Pain Therapy Section at the Jena University Hospital and are examined before and after an interdisciplinary, multimodal pain therapy with MEGA-PRESS proton MR spectroscopy and resting state functional MR imaging. This patient group will be compared to a second patient group that undergoes the same MR examination including its repetition after four weeks before they start their own therapy. In addition, a healthy control group will undergo the same MR protocol twice in an interval of 4 weeks. Primary endpoints of the study are differences in neurotransmitter concentrations (GABA and glutamate) and functional connectivity in specific brain regions (insular, anterior cingular and medial prefrontal cortex) between healthy controls and patients with chronic back pain at baseline. Further, changes induced by multimodal pain therapy in these parameters will be compared between patients undergoing therapy and those in the waiting group. Secondary endpoints are changes in pain related questionnaire data and the association of these variables with MRI-data.

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Organizational Data

  •   DRKS00009849
  •   2016/01/18
  •   [---]*
  •   yes
  •   Approved
  •   1861-09/06, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   chronic back pain
  •   M54.0 -  Panniculitis affecting regions of neck and back
  •   M54.2 -  Cervicalgia
  •   M54.3 -  Sciatica
  •   M54.4 -  Lumbago with sciatica
  •   M54.5 -  Low back pain
  •   M54.6 -  Pain in thoracic spine
  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
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Interventions/Observational Groups

  •   therapy group: patients with chronic back pain (baseline measurement before 4 week multimodal pain therapy and post measurement immediately after the end of therapy)
    Measurements:
    resting-state fMRI (functional connectivity) and MEGA-PRESS MR-spectroscopy (GABA and glutamate concentrations) focussing the insular and anterior cingular cortex as well as the medial prefrontal cortex
  •   waiting group: patients with chronic back pain during waiting phase (2 measurements in an interval of 4 weeks)
  •   control group: healthy controls (2 measurements in an interval of 4 weeks)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment, Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

resting-state fMRI (functional connectivity) and MEGA-PRESS MR-spectroscopy (GABA and glutamate concentrations) focussing the insular and anterior cingular cortex as well as the medial prefrontal cortex:
(1) Comparison of neurotransmitter concentrations and functional connectivity patterns between patients and healthy controls at baseline.

(2) Comparisons of neurotransmitter changes and changes in functional connectivity between therapy group and waiting group at baseline and 4 weeks later.

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Secondary Outcome

Pain intensities (numeric rating scales), pain interference (Pain Disability Index), pain catastrophizing (Pain Catastrophizing Scale), pain experience (Short Form McGill pain questionnaire), quality of life (SF-12), symptoms of depression (Hospital Anxiety and Depression scale):

(1) therapy induced changes in questionnaire in the therapy group and compared to waiting group between baseline and 4 weeks later (2) correlative analysis of changes in neurotransmitter concentration and functional connectivity and questionnaire data

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2016/02/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   65   Years
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Additional Inclusion Criteria

(1) chronic back pain since 6 months or more with pain intensity of more than 3 (11-step NRS) that cannot be adequately ascribed to any somatic impairment
(2) Age between 20-65 years
(3) Right-handedness
(4) suitability for MRI assessment
(5) written informed consent

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Exclusion Criteria

(1) primary somatic pain origns (e.g. herniated disc), which can be adressed with other dedicated therapeutic approach
(2) sensomotoric deficits of affected back area or corresponding nerve roots (i.e. symptoms of radicular pain)
(3) serious neurological or acute psychiatric comorbidities, cerebral abnormailities or brain developement deficits
(4) substance addiction
(5) benzodiazepine medication

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Addresses

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    • Arbeitsgruppe medizinische PhysikInstitut für diagnostische und interventionelle Radiologie (IDIR)
    • Mr.  Dr.-Ing.  Alexander  Gussew 
    • Philosophenweg 3
    • 07743  Jena
    • Germany
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    • Leiter Fachbereich SchmerztherapieKlinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Winfried  Meißner 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Arbeitsgruppe medizinische PhysikInstitut für diagnostische und interventionelle Radiologie (IDIR)
    • Mr.  Prof. Dr. rer. nat. med. habil.  Jürgen  Reichenbach 
    • Philosophenweg 3
    • 07743  Jena
    • Germany
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    • Arbeitsgruppe medizinische PhysikInstitut für diagnostische und interventionelle Radiologie (IDIR)
    • Mr.  Dr.-Ing.  Alexander  Gussew 
    • Philosophenweg 3
    • 07743  Jena
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Jena
    • Mr.  Philipp  Baumbach 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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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.