The primary objective of this study is to characterize the real-world outcomes of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Low back pain responder rate at 3 months post-activation as compared with
Baseline. A responder is defined as *30% low back pain reduction from Baseline
without change in opioids.
Secondary outcome
Secundary endpoints:
Change in average low back pain from Baseline to 3 months post-Activation
(Numeric Rating Scale)
Change in average leg pain from Baseline to 3 months post-Activation (NRS)
Percent pain relief of low back pain at 3 months post-Activation
Percent pain relief of leg pain at 3 months post-Activation
Change in low back pain with activity from Baseline to 3 months post-Activation
(NRS)
Change in leg pain with activity from Baseline to 3 months post-Activation (NRS)
Patient global impression of change at 3 months post-Activation
Change in disability from Baseline to 3 months post-Activation (ODI v2.1a)
Change in quality of life from Baseline to 3 months post-Activation (SF-36v2)
Exploratory endpoints:
Change in average low back pain from Baseline through 6, 12 months
post-Activation (NRS)
Change in average leg pain intensity from Baseline through 6, 12 months
post-Activation (NRS)
Change in low back pain intensity with activity from Baseline through 6, 12
months post-Activation (NRS)
Change in leg pain intensity with activity from Baseline through 6, 12 months
post-Activation (NRS)
Percent pain relief of low back pain through 6, 12 months post-Activation
Percent pain relief of leg pain through 6, 12 months post-Activation
Change in average daily leg pain intensity (NRS) from Baseline through 3, 12
months post-activation (Diary)
Change in average daily low back pain intensity (NRS) from Baseline through 3,
12 months post-activation (Diary)
Change in disability from Baseline Visit through 6, 12 months post-Activation
(ODI v2.1a)
Patient global impression of change through 6, 12 months post-Activation
Change in quality of life from Baseline Visit through 6, 12 months
post-Activation (SF-36v2)
Change in opioid prescription from Baseline through 6, 12 months
post-Activation (Concomitant Medications)
Health economic endpoint:
Economic value of HR-SCS at 12 months post-Activation (RUI, SF-36v2,
Concomitant Medications, Procedure Information)
Safety parameter:
Rate of occurrence of all device or procedure related adverse events (AEs),
SAEs including serious adverse device events (SADEs), unanticipated serious
adverse device effects (USADEs) through end of study.
Background summary
This study will investigate the effect of High Rate Spinal Cord Stimulation
(HR-SCS) in the treatment of chronic intractable low back pain.
Chronic intractable pain is often defined as pain persisting for at least 6
months which has not responded to conservative treatment(s). The pain may be
due to current or past nerve injury and causes significant disability, reduced
work productivity, reduced quality of life, and significant cost burden. Early
treatments for chronic pain typically include over the counter and prescription
medications. Later treatments like physical therapy and interventional pain
procedures (e.g. intraspinal injections, vertebroplasty, pulsed RF) are
attempted, sometimes followed by chronic high dose opioids and back surgery, if
indicated. If back surgery is unsuccessful in relieving the chronic pain, the
patient can be labeled as having failed back surgery syndrome (FBSS).
SCS is an option in the well-selected patient with chronic low back and/or leg
pain. SCS is has proven to be effective for chronic intractable pain associated
with a variety of conditions, including, but not limited to, FBSS, complex
regional pain syndrome, and low back pain and leg pain. SCS is a less invasive
treatment option for FBSS but has generally been reserved for patients who have
failed multiple, and indeed all possible, repeat operations.
Spinal cord stimulation as a treatment for chronic pain has been utilized since
the 1960s. Stimulation is delivered on a pulsatile basis, with frequencies of
pulse delivery typically programmed between 2 and 1200 Hz (1Hz = 1 pulse per
second).
High-Frequency (up to 10 kHz) spinal cord stimulation has been evaluated in
chronic pain patients. Nevro Corporation*s Senza* System (Menlo Park, CA)
delivers electrical stimulation at higher rates than conventional SCS devices
(Smet et al., 2011 a&b; Van Buyten et al., 2011). Data from previous European
clinical studies suggest that Nevro*s therapy may be effective in treating leg
and back pain and other challenging types of chronic pain that often do not
respond to conventional spinal cord stimulation (Smet et al., 2011 a&b; Van
Buyten et al., 2011). These data also indicate significant and sustained pain
reduction in patients with chronic back and leg pain.
Boston Scientific*s Precision SCS System with MultiWave Technology is capable
of providing stimulation at rates up to 10 kHz. The purpose of this study is to
characterize the real-world outcomes of HR-SCS therapy as an aid in the
management of chronic intractable pain of the trunk, including unilateral or
bilateral pain associated with the following: failed back surgery syndrome,
intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal
Cord Stimulator System with MultiWave Technology.
Study objective
The primary objective of this study is to characterize the real-world outcomes
of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the
management of chronic intractable pain of the trunk, including unilateral or
bilateral pain associated with the following: failed back surgery syndrome,
intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal
Cord Stimulator System with MultiWave Technology.
Study design
The study is a prospective, multi-center, single-arm study. This is a post CE
mark study, within the indications for use.
Intervention
Routine implantation of the Boston Scientific*s Precision SCS System with
MultiWave Technology
Study burden and risks
Subjects who take part in this study are subject to similar risks shared by all
subjects who receive this device but are not participating in this study. In
addition, this study is set up to collect data through questionnaires and
interviews. To complete these additional questionnaires and interviews the
subject will spend additional time at the hospital and/or doctor*s office. They
may have an increased number of visits to the hospital and/or doctor*s office
compared to standard of care.
The study subject may find it difficult, uncomfortable, or tiresome to complete
study visits,diary, and/or questionnaires. They may be uncomfortable with the
medication lock requirements.
The reported benefit of the PRECISION SCS System with MultiWave Technology may
include:
-Reduction in the intensity of chronic low back pain
-Reduction in the intensity of chronic leg pain
-Improvement in physical functioning (disability)
-Reduction in pain-related medication use
-Reduction in the occurrence of side-effects of pain-related medications
accompanied by reduction in opioid use (e.g. sleep disturbances, constipation,
reduction in mental acuity)
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Gaetano Martinolaan 50
Maastricht 6229 GS
NL
Listed location countries
Age
Inclusion criteria
-Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
-No back surgery within 6 months prior to Screening
-Average low back pain intensity of 6 or greater on a 0-10 numerical rating scale during Screening (NRS) as evaluated by interview
-Baseline Oswestry Disability Index score >40 and <81
-18 years of age or older when written informed consent is obtained
Exclusion criteria
-Average leg pain is greater than or equal to average low back pain during Screening (NRS).
-Radiographic evidence of spinal instability requiring fusion
-Require implantation of lead(s) in the cervical epidural space
-Requires implantation of paddle-style SCS lead(s) via a laminotomy and/or laminectomy
-Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
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 | NL56750.091.16 |