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

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain; Failed Back Surgery Syndrome; Post-Laminectomy Syndrome
• Intervention / Treatment: Device: SCS and PNfS; Device: SCS Alone

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Eon or Eon Mini IPG neurostimulation system with associated components
Active Comparator: SCS Alone; Eon or Eon Mini IPG with epidural leads in the spinal column	Device: SCS Alone; Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.; Other Names: Eon or Eon Mini IPG neurostimulation system with associated components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Evaluation of device or procedure related adverse events	6 months
Efficacy	Responder rate in SCS-PNfS vs SCS alone	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life	3 months
Functional Disability	3 months
Worst pain	3 months
Rescue medication usage	3 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Porter McRoberts, MD, Holy Cross Orthopedic Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Low Back Pain; Spinal Cord Stimulation; Failed Back surgery Syndrome; Post-Laminectomy Syndrome; Peripheral Nerve field Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Syndrome; Back Pain; Low Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: C-11-12