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SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study (SENSE)

Primary Purpose

Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCS and PNfS
SCS Alone
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring Low Back Pain, Failed Back surgery Syndrome, Post-Laminectomy Syndrome, Spinal Cord Stimulation, Peripheral Nerve field Stimulation, Pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Pain Center of Arizona
  • Valley Pain Consultants - N. Scottsdale
  • Arizona Pain Specialists
  • The Mocek Spine Clinic
  • Comprehensive Pain Management Center
  • Coastal Pain & Spinal Diagnostics Medical Group
  • Pacific Pain Medicine Consultants
  • Pasadena Rehabilitation Institute
  • Bright Health Physicians of PIH
  • Comprehensive Pain Specialists
  • Holy Cross Orthopedics
  • H. Lee Moffitt Cancer and Research Institute
  • Pain Care LLC
  • Interventional Pain Care
  • Bluegrass Pain
  • Mid Atlantic Spine and Pain Physicians
  • Michigan Pain Specialists
  • Comprehensive Pain & Rehabilitation
  • Montefiore Medical Center
  • Neurological Surgery, P.C.
  • Duke University Medical Center
  • Carolina Pain Institute
  • Integrated Pain Solutions
  • Pain and Spine Center
  • Performance Spine and Sports Physicians, P.C.
  • Vertex Spine and Pain
  • Granger Pain and Spine
  • The Center for Pain Relief

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCS and PNfS

SCS Alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety
Evaluation of device or procedure related adverse events
Efficacy
Responder rate in SCS-PNfS vs SCS alone

Secondary Outcome Measures

Quality of Life
Functional Disability
Worst pain
Rescue medication usage

Full Information

First Posted
November 15, 2013
Last Updated
April 11, 2016
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01990287
Brief Title
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
Acronym
SENSE
Official Title
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCS and PNfS
Arm Type
Experimental
Arm Description
Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field
Arm Title
SCS Alone
Arm Type
Active Comparator
Arm Description
Eon or Eon Mini IPG with epidural leads in the spinal column
Intervention Type
Device
Intervention Name(s)
SCS and PNfS
Other Intervention Name(s)
Eon or Eon Mini IPG neurostimulation system with associated components
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SCS Alone
Other Intervention Name(s)
Eon or Eon Mini IPG neurostimulation system with associated components
Intervention Description
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
Primary Outcome Measure Information:
Title
Safety
Description
Evaluation of device or procedure related adverse events
Time Frame
6 months
Title
Efficacy
Description
Responder rate in SCS-PNfS vs SCS alone
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
3 months
Title
Functional Disability
Time Frame
3 months
Title
Worst pain
Time Frame
3 months
Title
Rescue medication usage
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Porter McRoberts, MD
Organizational Affiliation
Holy Cross Orthopedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Valley Pain Consultants - N. Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Arizona Pain Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
The Mocek Spine Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Comprehensive Pain Management Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Coastal Pain & Spinal Diagnostics Medical Group
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Pacific Pain Medicine Consultants
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pasadena Rehabilitation Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Bright Health Physicians of PIH
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Comprehensive Pain Specialists
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80020
Country
United States
Facility Name
Holy Cross Orthopedics
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
H. Lee Moffitt Cancer and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Pain Care LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Interventional Pain Care
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47302
Country
United States
Facility Name
Bluegrass Pain
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Mid Atlantic Spine and Pain Physicians
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Michigan Pain Specialists
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Comprehensive Pain & Rehabilitation
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Neurological Surgery, P.C.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina Pain Institute
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Integrated Pain Solutions
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Pain and Spine Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Performance Spine and Sports Physicians, P.C.
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Vertex Spine and Pain
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Granger Pain and Spine
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
The Center for Pain Relief
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Learn more about this trial

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

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