Trial document




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  DRKS00019083

Trial Description

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Title

Evaluation of the SCS-Burst Stimulation

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Trial Acronym

SCS Burst-Stimulation

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URL of the Trial

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Brief Summary in Lay Language

Up to now, in the treatment of chronic pain by means of epidural numerous stimulation (spinal cord stimulation, SCS) usually stimulation was carried out with frequencies ranging between 20 and 150 Hz. This type of stimulation causes a pleasant paraesthesia, which can be perceived by the patient.
Recent developments are the high-frequency stimulation with 10,000 Hz and burst stimulation. Burst stimulation consists of groups on five High-frequency impulses (so-called bursts), which are applied in the frequency of 40 Hz. Both methods lead to pain reduction without a simulation- induced paraesthesia. The aim of the study is to investigate which number of single impulses is most effective in burst stimulation.

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Brief Summary in Scientific Language

Epidural neurostimulation (spinal cord stimulation, SCS) is a treatment option for chronic neuropathic pain which has proven efficiency in over 40 years. In recent years, the method has gained much interest by technical developments and by the implementation of novel stimulation paradigms. While in conventional numerous stimulation, a relatively low frequent electrical current is employed, high-frequency is characterised By frequencies up to 10,000 Hz.
A further new stimulation method is burst stimulation, where single packages of relatively high frequent impulses (so-called bursts) are applied in the frequency of 40 Hz. The efficiency of this stimulation, paradigms has been proven in a number of studies in patients with chronic post operated radicular pain or patients with diabetic polyneuropathy. While in the first description of this stimulation paradigm five single impulses in each burst were used, recent impulse generator is able to supply 2-7 single impulses with different frequencies and impulse durations.
Recent concepts assume, that also the stimulation density (the proportion of time in which stimulation is applied) plays a role in the efficiency of stimulation. In contrast, burst stimulation has shown a slightly higher efficiency as compared to high-frequency stimulation with 500 Hz. Also a clinical study comparing burst stimulation and 10,000 Hz stimulation showed the higher efficiency of burst stimulation, at least regarding leg pain.
The present study shall investigate, which number of single impulses is most effective in burst stimulation.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019083
  •   2019/12/16
  •   [---]*
  •   yes
  •   Approved
  •   3/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   R52.2 -  Other chronic pain
  •   M79.2 -  Neuralgia and neuritis, unspecified
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Interventions/Observational Groups

  •   Burst stimulaion with 2 Spikes
  •   Burst stimulaion with 5 Spikes
  •   Burst stimulaion with 7 Spikes
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

pain intensity under different number of spikes

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Secondary Outcome

frequency and duration of return to conventional stimulation under different number of spikes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/12/13
  •   14
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Age 18-80 Years, SCS with a system compatible with study requirements

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Exclusion Criteria

- stimulation systems exclusively for high frequency or conventional stimulatoion
- severe psychiatric comorbidity
- lingual or cognitive inability to understand study objective

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Addresses

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    • Interdisziplinäres SchmerzzentrumUKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres SchmerzzentrumUKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
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    • Interdisziplinäres SchmerzzentrumUKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Interdisziplinäres SchmerzzentrumUKL Freiburg
    • Mr.  PD Dr. med.  Tilman  Wolter 
    • Breisacherstr.117
    • 79106  Freiburg
    • Germany
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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.