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.
Brief Title
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
Completion Date
Completion Date Type
Actual
Conditions
Failed Back Surgery Syndrome
Post-Laminectomy Syndrome
Low Back Pain
Eligibility Criteria
Key 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)
Key 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)
* 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)
Key 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)
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Keywords
Low Back Pain
Failed Back surgery Syndrome
Post-Laminectomy Syndrome
Spinal Cord Stimulation
Peripheral Nerve field Stimulation
Pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
22 Years
NCT Id
NCT01990287
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
C-11-12
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Primary Outcomes
Outcome Description
Evaluation of device or procedure related adverse events
Outcome Measure
Safety
Outcome Time Frame
6 months
Outcome Description
Responder rate in SCS-PNfS vs SCS alone
Outcome Measure
Efficacy
Outcome Time Frame
3 months
Secondary Outcomes
Outcome Time Frame
3 months
Outcome Measure
Quality of Life
Outcome Time Frame
3 months
Outcome Measure
Functional Disability
Outcome Time Frame
3 months
Outcome Measure
Worst pain
Outcome Time Frame
3 months
Outcome Measure
Rescue medication usage
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
22
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sayed Wahezi
Investigator Email
swahezi@montefiore.org
Investigator Phone