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TerminatedNCT01990287SENSEUpdated Apr 13, 2016

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

An interventional study of SCS and PNfS and SCS Alone in Failed Back Surgery Syndrome, Post-Laminectomy Syndrome and Low Back Pain, sponsored by Abbott Medical Devices. Terminated at 28 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Failed Back Surgery Syndrome

101 studies on the registry are indexed under Failed Back Surgery Syndrome; 16 are open to participants now.

This study's enrollment of 38 is close to the median of 40 across 73 interventional studies indexed under Failed Back Surgery Syndrome.

Browse Failed Back Surgery Syndrome studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Browse Abbott Medical Devices studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    SCS and PNfS

    Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field

    Device: SCS and PNfS

  • Active comparator
    SCS Alone

    Eon or Eon Mini IPG with epidural leads in the spinal column

    Device: SCS Alone

Interventions

  • DeviceSCS 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.

    Also known as: Eon or Eon Mini IPG neurostimulation system with associated components

  • DeviceSCS Alone

    Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.

    Also known as: Eon or Eon Mini IPG neurostimulation system with associated components

06

What researchers measure

Primary outcomes

  1. Safety

    Evaluation of device or procedure related adverse events

    Time frame: 6 months

  2. Efficacy

    Responder rate in SCS-PNfS vs SCS alone

    Time frame: 3 months

Secondary outcomes

  1. Quality of Life

    Time frame: 3 months

  2. Functional Disability

    Time frame: 3 months

  3. Worst pain

    Time frame: 3 months

  4. Rescue medication usage

    Time frame: 3 months

07

Study locations

28 sites
  • The Pain Center of Arizona
    Phoenix, Arizona 85027, United States
  • Valley Pain Consultants - N. Scottsdale
    Scottsdale, Arizona 85254, United States
  • Arizona Pain Specialists
    Scottsdale, Arizona 85255, United States
  • The Mocek Spine Clinic
    Little Rock, Arkansas 72202, United States
  • Comprehensive Pain Management Center
    Campbell, California 95008, United States
  • Coastal Pain & Spinal Diagnostics Medical Group
    Carlsbad, California 92009, United States
  • Pacific Pain Medicine Consultants
    Oceanside, California 92056, United States
  • Pasadena Rehabilitation Institute
    Pasadena, California 91105, United States
  • Bright Health Physicians of PIH
    Whittier, California 90602, United States
  • Comprehensive Pain Specialists
    Broomfield, Colorado 80020, United States
  • Holy Cross Orthopedics
    Fort Lauderdale, Florida 33301, United States
  • H. Lee Moffitt Cancer and Research Institute
    Tampa, Florida 33612, United States
  • Pain Care LLC
    Stockbridge, Georgia 30281, United States
  • Interventional Pain Care
    Muncie, Indiana 47302, United States
  • Bluegrass Pain
    Louisville, Kentucky 40241, United States
  • Mid Atlantic Spine and Pain Physicians
    Elkton, Maryland 21921, United States
  • Michigan Pain Specialists
    Brighton, Michigan 48114, United States
  • Comprehensive Pain & Rehabilitation
    Pascagoula, Mississippi 39581, United States
  • Neurological Surgery, P.C.
    Lake Success, New York 11042, United States
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Carolina Pain Institute
    Winston-Salem, North Carolina 27103, United States
  • Integrated Pain Solutions
    Columbus, Ohio 43219, United States
  • Pain and Spine Center
    Dayton, Ohio 45417, United States
  • Performance Spine and Sports Physicians, P.C.
    Pottstown, Pennsylvania 19403, United States
  • Vertex Spine and Pain
    Franklin, Tennessee 37067, United States
  • Granger Pain and Spine
    West Jordan, Utah 84088, United States
  • The Center for Pain Relief
    Charleston, West Virginia 25301, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2013
First posted
Nov 21, 2013
Start
Nov 2013
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Apr 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01990287
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Nov 21, 2013
Start date
Nov 2013
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Apr 13, 2016

Study contacts

Porter McRoberts, MD
principal investigator · Holy Cross Orthopedic Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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