Comparison of DTM SCS Therapy Combined with standard pain treatment to standard pain treatment alone in the Treatment of Intractable Back Pain Subjects without previous history of Lumbar Spine Surgery
- Conditions
- chronicintractable back pain without history of back surgery.10041543neuropathic, refractory chronic back pain
- Registration Number
- NL-OMON54983
- Lead Sponsor
- SGX International LLC (SGX Health Europe)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
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.)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of randomized subjects who respond (a decrease in back pain VAS by<br /><br>at least 50% compared to baseline) to SCS therapy at 6 months (superiority<br /><br>analysis). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives of this study are to further demonstrate the<br /><br>effectiveness of the DTM-SCS when compared to CMM for the treatment of chronic<br /><br>pain of the trunk and limbs. This study will also include the characterization<br /><br>of the safety & health economic analytics of DTM-SCS.<br /><br><br /><br>Secondary outcome measures will be assessment at 1, 3, 6, 9, 12 and 24 month<br /><br>based on:<br /><br>- Pain - Visual Analogue Scale (VAS)<br /><br>- Disability - Oswestry Disability Index (ODI)<br /><br>- Quality of Life - European Quality of Life-5 Dimensions (EQ-5D-5L)<br /><br>- Patient's and clinician's global impression of change (PGIC)<br /><br>- Subject satisfaction questionnaire<br /><br>- Mental and Physical funcitonality - Health and Well-being questionnaire<br /><br>(SF-12)<br /><br>- Feedback paresthesia<br /><br>- Medication use - medication log<br /><br>- Work status - work status log<br /><br>- Safety - incidence adverse events (AEs)</p><br>