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Burst SCS evaluated


- candidate number17009
- NTR NumberNTR4479
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2014
- Secondary IDsNL48576.044.14 
- Public TitleBurst SCS evaluated
- Scientific TitleEffect of burst spinal cord stimulation evaluated in patients familiar with spinal cord stimulation
- ACRONYMSCS: Bursts
- hypothesisThe present mode of (tonic) SCS is accompanied by paraesthesia in the area of stimulation. Recently, a new mode of SCS has been developed which makes it possible to apply spinal cord stimulation without paraesthesias. This mode is called burst stimulation, in which is periods of stimulation are interspersed with periods without stimulation. Burst SCS, makes it not only possible to stimulate without paresthesias, but could possibly also be more effective in the treatment of neuropathic pain. In this study we want to evaluate which mode of SCS (burst stimulation, or conventional tonic stimulation) is the most effective for the treatment of neuropathic pain.
- Healt Condition(s) or Problem(s) studiedCentral neuropathic pain
- Inclusion criteriaOver 18 years, SCS for at least 3 months, Optimal tonic stimulation, SCS system type Eon, EonC, Eon mini or Prodigy (SJM, Plano, TX), Capable of participation: travelling to the hospital and filling out the questionnaires.
- Exclusion criteriaHospitalisation or other form of serious decline of general health, Severe pain that is interfering with the pain the SCS is used for, Received burst SCS in the past, Incapable of working with rechargeable system in the future.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-dec-2015
- Target number of participants58
- InterventionsPatients will receive two different SCS stimulator settings (burst and sham) each for a two week period.
- Primary outcomeThe main study parameters are the scores on the VAS for pain.
- Secondary outcomeSecondary parameters are the scores on VAS for quality of life, the McGill Pain Questionnaire, the Patients' Global Impression of Change (PGIC) scale, and the estimated walking distance. These scores will be compared for the conventional tonic, burst and sham stimulation situations. In a subgroup of patients with failed back surgery syndrome we will study the differences in brain activation between the stimulation settings, measured by changes in EEG features and evoked potentials.
- TimepointsDuring the 6 weeks study period, the patients will visit the hospital every two weeks. During those visits the primary and secondary will be evaluated.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.C. Tjepkema-Cloostermans
- CONTACT for SCIENTIFIC QUERIESIr. C.C. Vos, de
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-mrt-2014 - 21-apr-2014


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