Recruitment

Recruitment Status
Terminated
Estimated Enrollment
450

Inclusion Criterias

Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
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 is 22 years of age or older
...
Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
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 is 22 years of age or older
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 agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)

Exclusion Criterias

Subject has documented history of allergic response to titanium or silicone
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
...
Subject has documented history of allergic response to titanium or silicone
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
Subject with an infusion pump or any implantable neurostimulator device
Subject is immunocompromised
Subject has peripheral vascular disease
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)
Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
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 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

Summary

Conditions
  • Failed Back Surgery Syndrome
  • Low Back Pain
  • Post-Laminectomy Syndrome
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 22 years and 125 years
Gender
Both males and females

Inclusion Criterias

Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
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 is 22 years of age or older
...
Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
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 is 22 years of age or older
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 agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)

Exclusion Criterias

Subject has documented history of allergic response to titanium or silicone
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
...
Subject has documented history of allergic response to titanium or silicone
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
Subject with an infusion pump or any implantable neurostimulator device
Subject is immunocompromised
Subject has peripheral vascular disease
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)
Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
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 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

Locations

Franklin, Tennessee, 37067
Scottsdale, Arizona, 85254
Charleston, West Virginia, 25301
Whittier, California, 90602
Phoenix, Arizona, 85027
...
Franklin, Tennessee, 37067
Scottsdale, Arizona, 85254
Charleston, West Virginia, 25301
Whittier, California, 90602
Phoenix, Arizona, 85027
Oceanside, California, 92056
West Jordan, Utah, 84088
Muncie, Indiana, 47302
Campbell, California, 95008
Columbus, Ohio, 43219
Broomfield, Colorado, 80020
Little Rock, Arkansas, 72202
Pottstown, Pennsylvania, 19403
Bronx, New York, 10467
Winston-Salem, North Carolina, 27103
Dayton, Ohio, 45417
Carlsbad, California, 92009
Fort Lauderdale, Florida, 33301
Louisville, Kentucky, 40241
Pascagoula, Mississippi, 39581
Elkton, Maryland, 21921
Scottsdale, Arizona, 85255
Stockbridge, Georgia, 30281
Brighton, Michigan, 48114
Tampa, Florida, 33612
Pasadena, California, 91105
Durham, North Carolina, 27710
Lake Success, New York, 11042

Tracking Information

NCT #
NCT01990287
Collaborators
Not Provided
Investigators
  • Principal Investigator: Porter McRoberts, MD Holy Cross Orthopedic Institute
  • Porter McRoberts, MD Holy Cross Orthopedic Institute