The purpose of the clinical study is to demonstrate sustainable pain control and positive psychosocial and functional effects using a neuromodulation system using Burst stimulation
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische pijnklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to evaluate sustainable pain relief with a multiple
waveform enabled neurostimulator.
Secondary outcome
The secondary objectives are to evaluate the psychosocial and functional
responses to burst and tonic stimulation.
Background summary
Spinal cord stimulation (SCS) is a minimally invasive and reversible procedure
in which electrical leads are placed in the epidural space, applying
stimulation to the large myelinated fibers of the dorsal column. SCS is
becoming an increasingly popular alternative for the treatment of chronic,
intractable pain.
A systematic review and meta-analysis of SCS in refractory neuropathic back and
leg pain documented that SCS reduces pain, improves quality of life, reduces
analgesic use, allows some patients to return to work, and may also result in
significant cost savings over time, while having minimally significant adverse
events.
In an effort to continue to optimize neurostimulation treatment and provide
patients with options, the Prodigy (MRI)* and Proclaim EliteTM system have been
developed.
Both systems enable the use of both tonic stimulation and Burst stimulation.
With tonic stimulation the pulse is delivered at the same amplitude, frequency
and pulse width and typically produces paresthesia (tingling sensation) over
the patient*s area of pain.
During burst stimulation groups of pulses called bursts trains are repeated at
a burst rate; within each burst train; several pulses are issued at an
intra-burst rate.Individual pulses are characterized by a pulse amplitude and
pulse width in exactly the same manner as in tonic Stimulation. The amplitudes
used for Burst programming are reported to be significantly lower than those
traditionally used for tonic Stimulation which often results in paresthesia
free therapy with continued pain suppression.
Pain stimuli are likely processed in parallel by two pathways: the lateral
discriminatory pathways that helps to identify the location, type and intensity
of pain and the medial affective/attentional pathway that helps to drive
attention and salience to the pain
The current working hypothesis is that Burst stimulation may exert its main
effect through an ability to modulate both lateral & medial pathways whilst
tonic stimulation only affects the lateral pathway.
The purpose of the proposed clinical study is to collect data to evaluate
sustainable pain control by using a neuromodulation system which enables both
tonic and Burst stimulation.
Study objective
The purpose of the clinical study is to demonstrate sustainable pain control
and positive psychosocial and functional effects using a neuromodulation system
using Burst stimulation
Study design
A prospective, multicenter, single arm intervention study
Study burden and risks
There are no additional risks. The burden consists of a number of additional
questionnaires.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
2. Subject has a score of 6 or higher on the NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
4. Subject is 18 years of age or older at the time of enrollment.
5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.
Exclusion criteria
1. Subject currently has a spinal cord stimulation system implanted.
2. Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
5. Subject is currently participating in another clinical investigation with an active treatment arm.
6. Subject unable to read and/or write.
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 |
|---|---|
| CCMO | NL58153.078.16 |