SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
- Conditions
- Low Back PainFailed Back Surgery SyndromePost-Laminectomy Syndrome
- Registration Number
- NCT01990287
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy 3 months Responder rate in SCS-PNfS vs SCS alone
Safety 6 months Evaluation of device or procedure related adverse events
- Secondary Outcome Measures
Name Time Method Quality of Life 3 months Functional Disability 3 months Worst pain 3 months Rescue medication usage 3 months
Trial Locations
- Locations (28)
The Pain Center of Arizona
🇺🇸Phoenix, Arizona, United States
Valley Pain Consultants - N. Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arizona Pain Specialists
🇺🇸Scottsdale, Arizona, United States
The Mocek Spine Clinic
🇺🇸Little Rock, Arkansas, United States
Comprehensive Pain Management Center
🇺🇸Campbell, California, United States
Coastal Pain & Spinal Diagnostics Medical Group
🇺🇸Carlsbad, California, United States
Pacific Pain Medicine Consultants
🇺🇸Oceanside, California, United States
Pasadena Rehabilitation Institute
🇺🇸Pasadena, California, United States
Bright Health Physicians of PIH
🇺🇸Whittier, California, United States
Comprehensive Pain Specialists
🇺🇸Broomfield, Colorado, United States
Scroll for more (18 remaining)The Pain Center of Arizona🇺🇸Phoenix, Arizona, United States