The purpose of this study is to evaluate and document the safety information, how effective and cost effective the DTM SCS stimulation system is and the standard pain treatment in patients with chronic, difficult to treat back pain who are not…
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
neuropathic, refractory chronic back pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of randomized subjects who respond (a decrease in back pain VAS by
at least 50% compared to baseline) to SCS therapy at 6 months (superiority
analysis).
Secondary outcome
The secondary objectives of this study are to further demonstrate the
effectiveness of the DTM-SCS when compared to CMM for the treatment of chronic
pain of the trunk and limbs. This study will also include the characterization
of the safety & health economic analytics of DTM-SCS.
Secondary outcome measures will be assessment at 1, 3, 6, 9, 12 and 24 month
based on:
- Pain - Visual Analogue Scale (VAS)
- Disability - Oswestry Disability Index (ODI)
- Quality of Life - European Quality of Life-5 Dimensions (EQ-5D-5L)
- Patient's and clinician's global impression of change (PGIC)
- Subject satisfaction questionnaire
- Mental and Physical funcitonality - Health and Well-being questionnaire
(SF-12)
- Feedback paresthesia
- Medication use - medication log
- Work status - work status log
- Safety - incidence adverse events (AEs)
Background summary
It is estimated that about 20% percent of the population worldwide is affected
by moderate to severe chronic pain. Chronic pain becomes a burden to the
individual as this affects a person*s ability to carry out many daily life
activities, such as exercising, walking, driving a car, attending social
events, or performing household chores. In the United States, chronic pain is
considered one of the most pervasive and intractable conditions affecting at
least one third of the population at an estimated cost of five hundred billion
dollars per year, when combining health-related expenditure and the cost-impact
on loss of productivity and income.
Conventional medical management (CMM), including medication and physical
therapy, is often not adequate for treating chronic pain. Medication therapy
based on opioids may also lead to addiction. Indeed, extensive use of opioid
medications in the United States has led to the declaration of an epidemic
crisis. When these treatments fail to provide pain relief, imaging is performed
to assess candidacy for back surgery. However, surgery is only indicated for
those patients with mechanical instability or pinched nerves. For the many
patients for whom imaging does not clearly show a cause of chronic back pain,
or for the patients that have confounding medical issues precluding an invasive
surgical procedure, there are few alternative treatment options. Furthermore,
surgical interventions have also failed to remediate severe cases of
neuropathies and intractable back pain for many patients.
Spinal cord stimulation (SCS) is a proven therapy that has been in use for
about 50 years for various types of chronic pain. SCS is a reversible therapy
that allows patients to evaluate the therapy for several days using an external
neurostimulator (ENS) prior to receiving an implantable neurostimulator (INS)
system.
SCS utilizes pulsed electric fields that are applied to the dorsal section of
the spinal cord via electrode arrays, called leads, implanted in the epidural
space.
The Differential Target Multiplexed SCS (DTM SCS) programming approach relies
on stimulation parameters that will be set to levels that provide pain relief
yet well below the levels that could cause uncomfortable paresthesia, which may
result in significant pain relief from back and leg pain symptoms. This can be
done with programming parameters that are currently available on the IntellisTM
neurostimulator device (Medtronic, MN, USA).
In a given program group, DTM SCS will provide programs with different pulse
rates and pulse widths for the goal of better pain relief. The lower
stimulation amplitudes used in the DTM SCS programming approach could result
in patients experiencing less uncomfortable stimulation than with a
Conventional SCS programming approach. This is possible because a DTM SCS
program group contains programs that allow subjects to access amplitudes below
those that could cause uncomfortable paresthesia and make more adjustments to
the amplitude.
There is an ongoing post-market, open-label, prospective, randomized controlled
study (NCT03606187) evaluating the DTM SCS programming approach versus the
Conventional one. The study includes more than 100 subjects randomized in 12
sites in the U.S. At the 3-month primary endpoint, the responder rate
(percentage of subjects with >=50% pain relief) for DTM SCS programming was 80%
vs 51% for the active control arm. Thus, the study met the primary objective
for non-inferiority. A secondary objective of superiority of DTM SCS was also
met for the primary outcome. In addition, the mean percent of back pain relief
relative compared to baseline at the 3-months follow up for DTM SCS was 74%
vs. 46% for conventional programming.
Thus, the ongoing study has shown that DTM SCS is more effective than
conventional SCS at the 3-month primary endpoint of the study. Results also
show that DTM SCS shows a risk profile in line with that of the widely
documented profile for conventional SCS. Therefore, DTM SCS programming
approach offers an alternative programming approach to SCS that might help
thousands of chronic pain sufferers make substantial improvements in pain
relief, reduction in disabilities, and reduce the likelihood of uncomfortable
paresthesia.
The current study is a post-market, open-label, prospective, randomized,
controlled multi-center study that will evaluate DTM SCS programming with CMM
in comparison to CMM alone for chronic back pain sufferers with or without leg
pain. This scientifically sound study will provide more information on safety,
efficacy and health economic analytics for the DTM SCS programming approach.
Study objective
The purpose of this study is to evaluate and document the safety information,
how effective and cost effective the DTM SCS stimulation system is and the
standard pain treatment in patients with chronic, difficult to treat back pain
who are not considered to be suitable for spine surgery.
Study design
This is a post-market, open-label, prospective, randomized, controlled,
multi-center study comparing DTMTM SCS programming approach, delivered through
the CE marked IntellisTM neurostimulator, to Conventional Medical Management
(CMM).
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to
one of two study treatment groups:
• Test treatment group with DTMTM SCS programming approach with CMM
• Control treatment group with CMM alone
Data at follow-up visits will be compared between the two treatment groups, and
compared to baseline assessments collected at the beginning of the study.
There is an optional two-way crossover to the other treatment group available
for all subjects who remain in the study at the 6-months visit (certain
conditions to be fullfilled).
Study burden and risks
1. Side effects of the study medical device
The DTM spinal cord stimulation programming approach will be used with the
commercially available and approved IntellisTM spinal cord stimulation system.
The risks associated with spinal cord systems in general, are well
characterized in the system manuals for medical users and scientific journals
and are minimal compared to the side effects associated with most surgical
procedures or the use of many drugs used to treat chronic pain conditions.
The site effects associated with implanting the IntellisTM system are the same
as if the subject would not participate in the study. These possible site
effects and the possible side effects for the pain treatment in the control
group will be discussed with the study doctor.
The most common reported problems after neurostimulator implantation include :
infections, displacement of the leads, pain at the implant site, loss of
stimulation, and stimulation that does not meet expectations.
Additionally, the treatment is reversible and the device may be turned off
and/or removed at any time for any reason. The expected risks are minimal. At
each of the follow up visits, the subject's pain condition will be reviewed and
the therapy will be adjusted accordingly, if necessary.
The investigators are experienced in the diagnosis and treatment of chronic
pain, have proper surgical and clinical training and will take adequate steps
to ensure the subject's safety during implant procedures and throughout the
study. The investigators and study personnel participating in this study are
familiar with the elements of the system and their functions. However,
unanticipated risks may occur.
If during the study, new information becomes availble that could influence the
subject's decision about his/her participation, the study doctor will inform
the subject as soon as possible without any consequenses for the treatment.
2. Pregnancy
Women who are pregnant cannot participate in this study. Also, woman should not
become pregnant during the study. The spinal cord stimulator can affect the
unborn child. If the subject is of childbearing age and if the subject decides
to participate in this study, the subject should use one of the approved
methods of contraception to avoid becoming pregnant during the study. The
doctor will discuss with the subject the different options that are indicated.
3. Risks associated with the evaluation procedures specific to the study
If the subject is assigned to the spinal cord stimulation test group, they will
have X-rays taken during the surgery and possibly after activation of the
device, to check the electrodes. If the subject is assigned to the control
group, they may also need X-rays. For both groups this will be done according
to the ususal practice of the pain center and the risk is the same even if the
subject did not participate in this study.
Further more, this study collects data via questionnaires and no tests are
taken.
East Empire St. 2406
Bloomington, IL 61704
US
East Empire St. 2406
Bloomington, IL 61704
US
Listed location countries
Age
Inclusion criteria
A subject must MEET ALL of the following inclusion criteria:
1. Be a candidate for SCS system (trial and implant)
2. Have been diagnosed with chronic, refractory axial low back pain with or
without lower limb pain, with a neuropathic component as assessed by the
investigator, 6 months refractory to conventional therapy and are not eligible
for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at
the time of enrollment.
3. Has an average back pain intensity >= 6.0 cm on the 10.0 cm Visual Analog
Scale (VAS) at the time of enrollment
4. Be willing and capable of giving written informed consent to participate in
this clinical study based on voluntary agreement after a thorough explanation
of the subject*s participation has been provided.
5. Be willing and capable of subjective evaluation, read and understand written
questionnaires, and read, understand and sign the written inform consent.
6. Be 18 years of age or older at the time of enrollment
7. Be on a stable pain medication regimen, as determined by the study
investigator, for at least 30 days prior to enrolling in this study
8. Be willing and able to comply with study-related requirements, procedures,
and visits
Exclusion criteria
A subject must NOT MEET ANY of the following exclusion criteria:
1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy,
laminectomy, laminotomy)
2. Has a medical, anatomical, and/or psychosocial condition that is
contraindicated for commercially available IntellisTM SCS systems as determined
by the Investigator
3. Has a diagnosed back condition with inflammatory causes of back pain (e.g.,
onset of severe pain with activity), serious spinal pathology and/or
neurological disorders as determined by the investigator
4. Be concurrently participating in another clinical study
5. Has an existing active implanted device such as a pacemaker, another SCS
unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
6. Has a pain in other area(s) and/or medical condition requiring the regular
use of significant pain medications that could interfere with accurate pain
reporting, and/or confound evaluation of study endpoints, as determined by the
Investigator
7. Has mechanical spine instability as determined by the Investigator
8. Has undergone, within 30 days prior to enrollment, an interventional
procedure to treat back and/or leg pain, which is providing significant pain
relief
9. Has unresolved major issues of secondary gain (e.g., social, financial,
legal), as determined by the investigator
10. Be involved in an injury claim under current litigation or has a pending or
has a pending or approved worker*s compensation claim
11. Be pregnant (determined by urine testing unless female subject is
surgically sterile or post-menopausal. If female, sexually active, and
childbearing age, subject must be willing to use a reliable form of birth
control.)
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 |
|---|---|
| ISRCTN | ISRCTN10663814 |
| CCMO | NL74986.091.20 |