Evaluation of the SCS-Burst Stimulation
Organizational Data
- DRKS-ID:
- DRKS00019083
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-12-16
- Last update in DRKS:
- 2022-09-30
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SCS Burst-Stimulation
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- R52.2 - Other chronic pain
- ICD10:
- M79.2 - Neuralgia and neuritis, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Burst stimulaion with 2 Spikes
- Arm 2:
- Burst stimulaion with 5 Spikes
- Arm 3:
- Burst stimulaion with 7 Spikes
Endpoints
- Primary outcome:
- pain intensity under different number of spikes
- Secondary outcome:
- frequency and duration of return to conventional stimulation under different number of spikes
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Interdisziplinäres Schmerzzentrum, Universitätsklinikum Freiburg Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2019-12-01
- Actual study start date:
- 2019-12-13
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 14
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- Age 18-80 Years, SCS with a system compatible with study requirements
Exclusion Criteria
- stimulation systems exclusively for high frequency or conventional stimulatoion - severe psychiatric comorbidity - lingual or cognitive inability to understand study objective
Addresses
Primary Sponsor
- Address:
- Interdisziplinäres SchmerzzentrumUKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054810
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Interdisziplinäres SchmerzzentrumUKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Contact for Public Queries
- Address:
- Interdisziplinäres SchmerzzentrumUKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Principal Investigator
- Address:
- Interdisziplinäres SchmerzzentrumUKL FreiburgPD Dr. med. Tilman WolterBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Interdisziplinäres SchmerzzentrumUKL FreiburgBreisacherstr.11779106 FreiburgGermany
- Telephone:
- 0761/27054801
- Fax:
- 0761/27054990
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/schmerzzentrum.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-12-18
- Ethics committee number:
- 3/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-09-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry