SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

NCT01990287 | Terminated

• 1 other identifier: C-11-12
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 28

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Safety

  Evaluation of device or procedure related adverse events

  6 months

• Efficacy

  Responder rate in SCS-PNfS vs SCS alone

  3 months

Secondary Outcomes (4)

• Quality of Life

  3 months

• Functional Disability

  3 months

• Worst pain

  3 months

• Rescue medication usage

  3 months

Study Arms (2)

SCS and PNfS

EXPERIMENTAL

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

Device: SCS and PNfS

SCS Alone

ACTIVE COMPARATOR

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

Device: SCS Alone

Interventions

SCS and PNfS DEVICE

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

SCS and PNfS

SCS Alone DEVICE

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

SCS Alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (28)

The Pain Center of Arizona

Phoenix, Arizona, 85027, United States

Location

Valley Pain Consultants - N. Scottsdale

Scottsdale, Arizona, 85254, United States

Location

Arizona Pain Specialists

Scottsdale, Arizona, 85255, United States

Location

The Mocek Spine Clinic

Little Rock, Arkansas, 72202, United States

Location

Comprehensive Pain Management Center

Campbell, California, 95008, United States

Location

Coastal Pain & Spinal Diagnostics Medical Group

Carlsbad, California, 92009, United States

Location

Pacific Pain Medicine Consultants

Oceanside, California, 92056, United States

Location

Pasadena Rehabilitation Institute

Pasadena, California, 91105, United States

Location

Bright Health Physicians of PIH

Whittier, California, 90602, United States

Location

Comprehensive Pain Specialists

Broomfield, Colorado, 80020, United States

Location

Holy Cross Orthopedics

Fort Lauderdale, Florida, 33301, United States

Location

H. Lee Moffitt Cancer and Research Institute

Tampa, Florida, 33612, United States

Location

Pain Care LLC

Stockbridge, Georgia, 30281, United States

Location

Interventional Pain Care

Muncie, Indiana, 47302, United States

Location

Bluegrass Pain

Louisville, Kentucky, 40241, United States

Location

Mid Atlantic Spine and Pain Physicians

Elkton, Maryland, 21921, United States

Location

Michigan Pain Specialists

Brighton, Michigan, 48114, United States

Location

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Neurological Surgery, P.C.

Lake Success, New York, 11042, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Pain Institute

Winston-Salem, North Carolina, 27103, United States

Location

Integrated Pain Solutions

Columbus, Ohio, 43219, United States

Location

Pain and Spine Center

Dayton, Ohio, 45417, United States

Location

Performance Spine and Sports Physicians, P.C.

Pottstown, Pennsylvania, 19403, United States

Location

Vertex Spine and Pain

Franklin, Tennessee, 37067, United States

Location

Granger Pain and Spine

West Jordan, Utah, 84088, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; post laminectomy syndrome; Low Back Pain; Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Porter McRoberts, MD

  Holy Cross Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (28)