The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische pijn tengevolge van "Failed Back Surgery Syndrome"
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the proportion of subjects with a *50% reduction in low back pain
intensity, as measured by the NPRS, from baseline to the end of Period I in the
SCS group with that in the OMM group.
Secondary outcome
1. To compare change in low back pain intensity, as measured by the NPRS, from
baseline to the end of Period I for subjects in the SCS group with that in the
OMM group.
2. To compare change in leg pain intensity, as measured by the NPRS, from
baseline to the end of Period I for subjects in the SCS group with that in the
OMM group.
3. To compare change in functional disability, as measured by the ODI, from
baseline to the end of Period I for subjects in the SCS group with that in the
OMM group.
4. To compare change in quality of life, as measured by the SF-36 physical
component summary (PCS), from baseline to the end of Period I for subjects in
the SCS group with that in the OMM group.
Background summary
The use of SCS for pain control has been available for more than 40 years. In
SCS, a lead is positioned in the epidural space on the dorsal aspect of the
spinal cord to produce stimulation-induced paresthesia in the painful area. In
1967, Shealy et al. were the first to describe a case in which SCS was
successful in pain relief in a patient with cancer. This finding was the start
of the development of SCS as pain management in a variety of indications,
including FBSS. Numerous articles have been published and we have identified
six systematic reviews (SR), including one Cochrane review, on SCS in the
treatment of chronic pain in patients with FBSS or other back and/or leg pain
conditions. The SR conducted by Frey et al. (2009) included 2 randomized
controlled trials (RCTs) and 10 observational studies and concluded with a
strong recommendation for the long-term clinical use of SCS for the treatment
of FBSS of at least 12 months duration. In 2011, Kelly et al. published an SR
on the impact of SCS on physical function and sleep quality for FBSS patients.
In 13 studies the impact of SCS on physical function was investigated, and nine
studies addressed the impact of SCS on sleep quality. SCS positively affected
physical function and sleep quality; however, the evidence was not strong, and
the authors noted a need for high-quality data to provide additional
information about these additional beneficial effects of SCS.This evidence has
mainly been generated for predominant leg pain patients. Back pain and low
back pain might be less responsive to SCS than leg pain, although there is no
level 1 evidence demonstrating a differential the effectiveness of SCS in these
sub- populations. The anatomy and physiology of the spinal cord make it
challenging to elicit effective stimulation paresthesia for the low back area.
A single center case series published in 2012 suggests that SCS with the
Specify 5-6-5 surgical lead is effective in treating predominant low back
pain; however, no prospective controlled study data demonstrate the benefit of
SCS versus OMM in the treatment of FBSS patients with predominant back pain.
This study (PROMISE) is designed to address this gap in the evidence.
Study objective
The purpose of this study is to compare the effectiveness of spinal cord
stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead
plus optimal medical management (OMM) versus OMM alone in patients suffering
from predominant low back pain due to failed back surgery syndrome (FBSS).
Study design
The study has a multi-center, prospective, randomized, open-label,
parallel-group design. Subjects who meet all of the inclusion criteria and none
of the exclusion criteria will be randomized to receive one of two alternative
treatments:
* SCS group (SCS+OMM): In addition to the OMM described below, subjects will
undergo an SCS screening test and, if successful, an INS implant. Any SCS group
subject not implanted will continue to be treated with OMM and will be followed
as part of the SCS group.
* OMM group: Pain treatment will be evaluated, and medical management of
subjects* pain will be optimized. The investigator and subject will determine
an individual OMM treatment plan, which should include non-investigational
pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or
tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g.,
therapeutic injections, radiofrequency, acupuncture, and physical therapy) as
appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral
nerve stimulation (PNS; not an approved indication in the USA), back surgery at
the location related to his/her original back pain complaint and experimental
therapies. Data regarding pain treatments implemented during the study will be
collected to reveal how medical management was optimized.
Period I (6 months) is the randomized parallel group comparative phase. Time
zero for the study is the point of randomization. The randomization ratio is
1:1 (SCS to OMM). Period II is the long-term observational follow-up phase.
After completing the questionnaires at the 6-month visit subjects will be
systematically reminded that they are no longer in the randomized period of the
study and he/she has the option of adding or discontinuing SCS.
Intervention
SCS group (SCS+OMM): In addition to the OMM described below, subjects will
undergo an SCS screening test and, if successful, an INS implant. The
SCS-system includes a Specify 565 surgical lead, extenion (if applicable), een
implantable neurostimulator and the patient programmer.
OMM group: The investigator and subject will determine an individual OMM
treatment plan, which should include non-investigational pharmacologic agents
(e.g., tricyclic antidepressants, opioid analgesics or tramadol,
antiepileptics, or lidocaine) and/or interventional therapies (e.g.,
therapeutic injections, radiofrequency, acupuncture, and physical therapy) as
appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral
nerve stimulation (PNS; not an approved indication in the USA), back surgery at
the location related to his/her original back pain complaint and experimental
therapies
Study burden and risks
The burden is that it might cost the subject more time (more frequent and
longer visits) than with the treatment outside the study, but he recieves more
attention.
The risks are the same as for subjects who receive the treatment outside the
study (adverse events due to medical management, surgical and technical
complications for subjects with a SCS-system with surgical lead)
Burgemeester E. Demunterlaan 5
Brussel 1090
BE
Burgemeester E. Demunterlaan 5
Brussel 1090
BE
Listed location countries
Age
Inclusion criteria
1. Subject is a candidate for SCS with the Specify 5-6-5 surgical lead.
2. Subject has FBSS and does not require further surgery. For the purposes of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure.
3. Average low back pain is * 5 as assessed by the baseline NPRS.
4. Average low back pain is > leg pain as assessed by the baseline NPRS.
Exclusion criteria
1. Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies.
2. Low back pain only (no leg pain) as assessed by the baseline NPRS.
3. Subject has consistent severe pain (i.e., 10 out of 10) without fluctuation which might confound the results of this study.
4. Radiographic evidence of instability requiring fusion.
5. Pain relieved completely by recumbency (mechanical pain).
6. Subject has a life expectancy of less than 24 months beyond study enrollment.
7. Subject is pregnant or planning to become pregnant during the course of the study.
8. Subject is unable to undergo study assessments or complete questionnaires independently (e.g., is illiterate).
9. Subject is member of a vulnerable population
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 | NCT01697358 |
| CCMO | NL41881.008.12 |