SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
NCT ID: NCT01990287
Last Updated: 2016-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2013-11-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SCS and PNfS
Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field
SCS and PNfS
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
SCS Alone
Eon or Eon Mini IPG with epidural leads in the spinal column
SCS Alone
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
Interventions
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SCS and PNfS
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
SCS Alone
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
22 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Porter McRoberts, MD
Role: PRINCIPAL_INVESTIGATOR
Holy Cross Orthopedic Institute
Locations
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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
Holy Cross Orthopedics
Fort Lauderdale, Florida, United States
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States
Pain Care LLC
Stockbridge, Georgia, United States
Interventional Pain Care
Muncie, Indiana, United States
Bluegrass Pain
Louisville, Kentucky, United States
Mid Atlantic Spine and Pain Physicians
Elkton, Maryland, United States
Michigan Pain Specialists
Brighton, Michigan, United States
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, United States
Neurological Surgery, P.C.
Lake Success, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Pain Institute
Winston-Salem, North Carolina, United States
Integrated Pain Solutions
Columbus, Ohio, United States
Pain and Spine Center
Dayton, Ohio, United States
Performance Spine and Sports Physicians, P.C.
Pottstown, Pennsylvania, United States
Vertex Spine and Pain
Franklin, Tennessee, United States
Granger Pain and Spine
West Jordan, Utah, United States
The Center for Pain Relief
Charleston, West Virginia, United States
Countries
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Other Identifiers
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C-11-12
Identifier Type: -
Identifier Source: org_study_id
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