No registrations found.
ID
Source
Brief title
Health condition
neuropathic pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the scores on the VAS for pain.
Secondary outcome
Secondary 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.
Study objective
The 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.
Study design
During the 6 weeks study period, the patients will visit the hospital every two weeks. During those visits the primary and secondary will be evaluated.
Intervention
Patients will receive two different SCS stimulator settings (burst and sham) each for a two week period.
M.C. Tjepkema-Cloostermans
Enschede
The Netherlands
m.tjepkema-cloostermans@mst.nl
M.C. Tjepkema-Cloostermans
Enschede
The Netherlands
m.tjepkema-cloostermans@mst.nl
Inclusion criteria
Over 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 criteria
Hospitalisation 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4339 |
| NTR-old | NTR4479 |
| CCMO | NL48576.044.14 |