The main objective of the study is to test if burst SCS is clinically non-inferior to conventional SCS in patients already successfully treated with conventional SCS. The secondary objective of the study is to evaluate patient satisfaction and…
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical effectiveness of the SCS treatment for refractory angina will be
measured with the Seattle angina questionnaire (SAQ) comparing baseline
conventional stimulation with burst SCS at 1 month.
Secondary outcome
Patient satisfaction will be measured on a 11 point Numeric Rating Scale and
quality of life with the EQ5D.
Background summary
For decades, Spinal Cord Stimulation (SCS) has been used for the treatment of
refractory neuropathic and ischaemic pain. In conventional SCS, paraesthesias
are induced in the painful area through electrical stimulation of the spinal
cord. Recently new stimulation modes became available in which no paraesthesias
are perceived resulting in better patient comfort. These novel stimulation
modes have gathered evidence in the treatment of neuropathic pain. So far,
there are no reports of the appliance of these new modes for ischaemic pain,
despite the fact that they are often applied in clinical practice. Therefore,
we want to evaluate one of the novel modes, burst stimulation, for the
treatment of refractory angina pectoris. We hypothesize burst SCS will be
non-inferior compared to conventional SCS in clinical effectiveness with a
higher patient satisfaction.
Study objective
The main objective of the study is to test if burst SCS is clinically
non-inferior to conventional SCS in patients already successfully treated with
conventional SCS. The secondary objective of the study is to evaluate patient
satisfaction and quality of life with burst SCS. Gathered data will also be
used to calculate an adequate sample size for a future randomised controlled
trial.
Study design
The study is designed as a prospective observational pilot study in patients
with successful conventional SCS of their refractory angina. Their system will
be able to deliver both conventional and burst SCS. Burst stimulation will be
available as an extra program, providing patients with the possibility to fall
back on their conventional program anytime. Patients will be followed according
to normal clinical procedures. No extra measurements will be performed in the
setting of this observational study.
Intervention
After inclusion and measurement of base line parameters burst stimulation will
be programmed on the SCS device of the subjects. During 1 month treatment will
be with form of stimulation, with the possibility to go back to the old
traditional SCS program. After 1 month patients can choose their preffered
stimulation mode.
Study burden and risks
There is no extra burden for the participants of this study, nor are there
extra risks because their system is able to deliver both conventional and burst
SCS. The study parameters will be extracted from the routine questionnaires,
which are used in the standard follow-up according to the Dutch Association for
Neuromodulation (VvNN). A potential benefit for the participants is that burst
SCS results in the same clinical effect with a higher patient comfort due to
the absence of paraesthesias.
Bosboomstraat 1
Utrecht 3582KE
NL
Bosboomstraat 1
Utrecht 3582KE
NL
Listed location countries
Age
Inclusion criteria
- age 18 to 90 of either sex
- mentally competent and able to fill in the questionnaires
- implanted with an IPG capable of delivering both conventional and BurstDRTM
SCS
- no changes in anti-angina medication in the previous three months
- no procedures like PCI or CABG, nor instability of the clinical signs and
symptoms of refractory angina in the previous three months
- the implanted SCS system has no signs of hardware problems (normal lead
impedances)
- able to use the remote control I pod
Exclusion criteria
- signs of instable angina pectoris
- unexplained weight loss in the previous three months
- inability to visit the outpatient department for the follow-up visits
- unable to provide informed consent
- myocardial infarction or unstable angina in the previous three months
Design
Recruitment
Medical products/devices used
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 |
---|---|
CCMO | NL68293.018.18 |