The primary objective of this study is to confirm the long term efficacy of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische pijn waarvoor geen alternatieve behandeling meer is
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the percentage of pain relief at the 3-month visit
compared to baseline visit, as measured by the Visual Analog Scale (VAS).
Secondary outcome
• Pain relief at the 3-month visit compared to EMPOWER Perc post market study
(tonic stimulation)
• Paresthesia mapping at the 3-month visit. This endpoint will also be compared
to paresthesia mapping results from the EMPOWER Perc post market study (tonic
stimulation).
• Pain relief at the 12-month visit compared to baseline visit, as measured by
VAS
• Improvement of patient pain catastrophizing at the 12-month visit compared to
baseline visit, as measured by the Pain Catastrophizing Scale (PCS)
• Reduction of use of analgesics at the 12-month visit compared to baseline
visit
• Improvement of the quality of life at the 12-month visit compared to baseline
visit, as measured by the European Questionnaire-5 Dimensions
• Rate of serious adverse events (SAEs) and/or procedure/device-related adverse
events ((S)ADEs)
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 dorsal column. SCS has been used successfully to treat a
variety of pain conditions including, diabetic neuropathy3, failed back surgery
syndrome4,5,6,7, complex regional pain syndrome8,9, phantom limb pain10.
SCS reduces pain, improves quality of life, reduces analgesic use, while having
minimally significant adverse events
. The ProdigyTM system enables the use of both Tonic Stimulation and Burst
Stimulation. The programming option currently available with approved
neurostimulation devices, now referred to as Tonic Stimulation, is what
patients are using today where 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.
Burst Stimulation is a subset of the existing stimulation Cycle mode where
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.
The amplitudes used for burst programming are reported to be significantly
lower than those traditionally used for Tonic Stimulation which results in
paresthesia free therapy with continued pain suppression.
This option provides clinicians with more programming options for their
patients who wish to further individualize and optimize their neurostimulation
treatment.
Study objective
The primary objective of this study is to confirm the long term efficacy of the
ProdigyTM neuromodulation system in the management of failed back surgery
syndrome or chronic intractable pain of the trunk and/or limbs.
Study design
International, multicenter, interventional, prospective and single-arm design
Intervention
Implantation of Prodigy Spinal Cord Stimulation System
Study burden and risks
Subjects will not be exposed to risks other than those associated with the
risks of implantation of a SCS system.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
o Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
o Patient is considered by the investigator as a candidate for implantation of a SCS system
o Patient is >= 18 years of age
o Patient must be willing and able to comply with study requirements
o Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Exclusion criteria
o Patient is immune-compromised
o Patient has history of cancer requiring active treatment in the last 6 months
o Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
o Patients with a SCS system or implantable infusion pump implanted previously
o Patient has a life expectancy of less than one year
o Patient is pregnant or is planning to become pregnant during the duration of the investigation
o Patient is unable to comply with the follow up schedule
o Patient needing legally authorized representative
o Patient unable to read and write
o Patient is currently participating in another clinical investigation with an active treatment arm
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 |
|---|---|
| ClinicalTrials.gov | NCT02143791 |
| CCMO | NL48990.044.14 |