Clinical trial NCT01990287: SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
Official title: SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Post-Laminectomy Syndrome
Low Back Pain
Keywords: Low Back Pain
Failed Back surgery Syndrome
Post-Laminectomy Syndrome
Spinal Cord Stimulation
Peripheral Nerve field Stimulation
Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Safety
timeFrame: 6 months
measure: Efficacy
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
measure: Functional Disability
timeFrame: 3 months
measure: Worst pain
timeFrame: 3 months
measure: Rescue medication usage
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Valley Pain Consultants - N. Scottsdale
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
city: Little Rock
country: United States
facility: The Mocek Spine Clinic
state: Arkansas
city: Campbell
country: United States
facility: Comprehensive Pain Management Center
state: California
city: Carlsbad
country: United States
facility: Coastal Pain & Spinal Diagnostics Medical Group
state: California
city: Oceanside
country: United States
facility: Pacific Pain Medicine Consultants
state: California
city: Pasadena
country: United States
facility: Pasadena Rehabilitation Institute
state: California
city: Whittier
country: United States
facility: Bright Health Physicians of PIH
state: California
city: Broomfield
country: United States
facility: Comprehensive Pain Specialists
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Orthopedics
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer and Research Institute
state: Florida
city: Stockbridge
country: United States
facility: Pain Care LLC
state: Georgia
city: Muncie
country: United States
facility: Interventional Pain Care
state: Indiana
city: Louisville
country: United States
facility: Bluegrass Pain
state: Kentucky
city: Elkton
country: United States
facility: Mid Atlantic Spine and Pain Physicians
state: Maryland
city: Brighton
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: Pascagoula
country: United States
facility: Comprehensive Pain & Rehabilitation
state: Mississippi
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Lake Success
country: United States
facility: Neurological Surgery, P.C.
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Pain Institute
state: North Carolina
city: Columbus
country: United States
facility: Integrated Pain Solutions
state: Ohio
city: Dayton
country: United States
facility: Pain and Spine Center
state: Ohio
city: Pottstown
country: United States
facility: Performance Spine and Sports Physicians, P.C.
state: Pennsylvania
city: Franklin
country: United States
facility: Vertex Spine and Pain
state: Tennessee
city: West Jordan
country: United States
facility: Granger Pain and Spine
state: Utah
city: Charleston
country: United States
facility: The Center for Pain Relief
state: West Virginia
Study officials:
affiliation: Holy Cross Orthopedic Institute
name: Porter McRoberts, MD
role: PRINCIPAL_INVESTIGATOR
References: