Focal Pain Outcomes using Configurations Applied for Lateral Stimulatio
- Conditions
- chronic painFocal pain1004154310009720
- Registration Number
- NL-OMON51221
- Lead Sponsor
- Boston Scientific International BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 8
IC1. Average unilateral foot, knee, or groin pain (of neuropathic origin only)
intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit
based on 7-day average NRS score
IC2. Subject signed a valid, EC-approved informed consent form (ICF)
IC3. Willing and able to comply with all protocol-required procedures and
assessments/evaluations
IC4. At least 80% pain/paresthesia overlap during on-table testing for each set
of implanted leads
Patients with at least 80% pain/paresthesia overlap at DC/DR leads only will be
part of the DC/DR subgroup
IC5. If taking prescription opioids for primary chronic pain complaint (low
back and/or leg and/or foot and/or knee and/or groin pain), must have been on a
stable prescription (same drug(s) and dose(s)) 30 days prior to Screening
IC6. Consumed an average total daily morphine equivalent of *100 mg during the
30 days prior to Screening
IC7. 18 years of age or older when written informed consent is obtained
EC1. Significant cognitive impairment at Screening that, in the opinion of the
Investigator, would reasonably be expected to impair the study candidates to
participate in the study
EC2. Previous spinal cord stimulation trial or is already implanted with an
active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse
generator).
EC3. Participating (or intends to participate) in another drug or device
clinical trial that may influence the data that will be collected for this
study
EC4. Currently on any anticoagulant medications that cannot be discontinued
during perioperative period
EC5. A female who is pregnant, is breastfeeding, or is of childbearing
potential and planning to get pregnant during the course of the study or not
using adequate contraception.
EC6. Clinically significant lumbosacral stenosis which would interfere with
lead placement
EC7. Prior history of lumbar-sacral spine fusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>There is no primary endpoint. Collected data will be used to increase the<br /><br>understanding of the therapy, guide product development and help define the<br /><br>best practice for programming patients with focal foot, knee, or groin pain<br /><br>using Spinal Cord Stimulation devices.</p><br>
- Secondary Outcome Measures
Name Time Method