SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

Abbott

Status

Terminated

Conditions

Post-Laminectomy Syndrome

Low Back Pain

Failed Back Surgery Syndrome

Treatments

Device: SCS Alone

Device: SCS and PNfS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01990287

C-11-12

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)