NCT01990287TerminatedNot Applicable
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Abbott Medical Devices
- Enrollment
- 38
- Locations
- 56
- Primary Endpoint
- Safety
Study Overview
Brief Summary
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 22 years of age or older
- •Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
- •Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
- •Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
- •Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
- •Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
Exclusion Criteria
- •Subject currently participating in a clinical investigation that includes an active treatment arm
- •Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
- •Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
- •Subject with an infusion pump or any implantable neurostimulator device
- •Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
- •Subject has an existing medical condition that is likely to require the use of diathermy in the future
- •Subject has peripheral vascular disease
- •Subject is immunocompromised
- •Subject has documented history of allergic response to titanium or silicone
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
- •Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
Outcomes
Primary Outcomes
Safety
Time Frame: 6 months
Evaluation of device or procedure related adverse events
Efficacy
Time Frame: 3 months
Responder rate in SCS-PNfS vs SCS alone
Secondary Outcomes
- Quality of Life(3 months)
- Functional Disability(3 months)
- Worst pain(3 months)
- Rescue medication usage(3 months)
Investigators
Study Sites (56)
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