Trial document




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  DRKS00011267

Trial Description

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Title

Assessment of peripheral pro- and anti-neuroinflammatory cytokine changes in blood and saliva biofluids by enzyme-linked immune assay (ELISA) in neuropathic refractory post-surgical knee pain syndrome (CPSP) treated with dorsal root ganglion stimulation (SCS-DRG) and analysis of possible correlation between peripheral cytokine changes and DRG-associated pain and functional state (depression, sleep architecture, body weight) responsiveness

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Trial Acronym

neuropathic refractory post-surgical knee pain syndrome (CPSP)

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URL of the Trial

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Brief Summary in Lay Language

This study examines the effect of dorsal root ganglion (SCS-DRG) stimulation in patients with refractory chronic postoperative knee pain (CPSP).
In Addition, SCS-DRG, cytokine changes before and after 3 and 12 months stimulation will be assessed in order to determine possible relationship between SCS-DRG outcome and responsiveness and cytokine plasma level changes. An additional subgroup of patients will undergo On/Off Stimulation Evaluation after 12 months.

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Brief Summary in Scientific Language

The study will examine the pain-modulating effects of minimally invasive spinal ganglion stimulation (SCS-DRG) in patients with refractory chronic postoperative knee pain.
DRG stimulation is a minimally invasive form of therapy in neuromodulation to stimulate spinal ganglion. A total of 15 patients are treated.
Clinical evaluations include the severity of pain (VAS), sleep quality (PSQI), severity of depression (BDI), and enzyme-linked immunosorbent assay (ELISA).

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Organizational Data

  •   DRKS00011267
  •   2016/11/11
  •   2016/11/15
  •   no
  •   Approved
  •   258/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   M79.66 -  [generalization M79.6: Pain in limb]
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Interventions/Observational Groups

  •   Study of minimally invasive spinal ganglion stimulation in 15 patients with therapy-refractory chronic postoperative knee pain (CPSP).
    Subjective assessments for the measurement of the VAS, BDI and PSQI as well as an objective measurement by ELISA. In addition, the QST examination procedure is used, which allows conclusions as to whether neuropathic pain and which pain symptoms are present in the CPSP patients. Data / measurements are collected at the beginning, after 3 and 12 months follow up.
    After 12 months a further subgroup analysis follows with an Stimulation-OFF MODE of 48h.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Data capture of the baseline pain relief and after 3 and 12 months by means of the visual analog scale VAS.
Data capture baseline sleep behavior and after 3 and 12 months with questionnaire PSQI.
Data capture of intensity of depression Baseline, and after 3 and 12 months using the BDI questionnaire.
Laboratory data capture parameters Oxytocin and CGRP Baseline and after 3 and 12 months
Data capture of pain sensitivity by using the QST examination procedure.
Assessment of peripheral pro- and anti-neuroinflammatory cytokine changes in blood and saliva biofluids by enzyme-linked immune assay (ELISA).

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Secondary Outcome

Detection of the changes in peripheral pro and anti-neuroinflammatory cytokines (IL-1 beta, IL-10, CGRP) caused by the stimulation of spinal ganglion (SCS-DRG) and the oxcytocin concentration in renitent CPSP patients.
Detection of a possible relationship between the peripheral pro- and anti-neuroinflammatory cytokine alterations of IL-1, IL-10, CGRP and oxcytocin with subjective pain perception after SCS-DRG treatment, measurement of pain sensitivity (QST) and the extent of improved functionalities BDI, PSQI, BMI)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/11/21
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients, with confirmed chronic postoperative knee pain (CPSP).
Not suitable for further surgical procedures in the knee Region.
Commitment for SCS-DRG System.
Unchanged medication 4 weeks before SCS-DRG Implantation.

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Exclusion Criteria

-Other neurological disorders (traumatic brain injury)
-Substance abuse
-Neuropsychiatric Disorders,
-Pregnancy
-Cardiovascular diseases
-Not willing to provide follow-up
- Pregnancy

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Addresses

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    • St. Jude Medical GmbH
    • Helfmann-Park 7
    • 65760  Eschborn
    • Germany
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    • Klinik für Psychiatrie, Abteilung Medizinische Psychologie
    • Mr.  Prof  Rene  Hurlemann 
    • Sigmund-Freud-Str.23
    • 53105  Bonn
    • Germany
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    • Klinik für Psychiatrie, Abteilung Medizinische Psychologie
    • Mr.  PD Dr.med.  Thomas M.  Kinfe 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik für Psychiatrie, Abteilung für Medizinische Psychologie
    • Mr.  PD Dr.med.  Thomas M.  Kinfe 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • St. Jude Medical GmbH
    • Helfmann-Park 7
    • 65760  Eschborn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.