Overview
The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.
Eligibility
Inclusion Criteria:
- Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
- Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months
- At least 6 months since last surgical procedure on the spine
- Be 21 years of age or older at the time of enrollment
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements
Exclusion Criteria:
- Any prior spinal fusion at index or adjacent level
- Pregnant
- Have a life expectancy of less than 1 year
- Be concomitantly participating in another clinical study
- Be involved in an injury claim under current litigation
- Baseline narcotic use of ≥ 100 MME per day
- Significant untreated addiction to dependency producing medications
- Current active implantable medical device
- Cancer
- Have osteoporosis
- Active infection
- Allergies to system components
- AGE > 80
- Expected need to undergo MRI imaging in the future
- Other significant comorbidities