SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

Not Applicable

Terminated

• Conditions: Low Back Pain; Failed Back Surgery Syndrome; Post-Laminectomy Syndrome
• Interventions: Device: SCS and PNfS; Device: SCS Alone

• Registration Number: NCT01990287
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCS and PNfS	SCS and PNfS	Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field
SCS Alone	SCS Alone	Eon or Eon Mini IPG with epidural leads in the spinal column

Primary Outcome Measures

Name	Time	Method
Safety	6 months	Evaluation of device or procedure related adverse events
Efficacy	3 months	Responder rate in SCS-PNfS vs SCS alone

Secondary Outcome Measures

Name	Time	Method
Quality of Life	3 months
Functional Disability	3 months
Worst pain	3 months
Rescue medication usage	3 months

Trial Locations

Locations (28)

Valley Pain Consultants - N. Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Comprehensive Pain Management Center; 🇺🇸 Campbell, California, United States

Mid Atlantic Spine and Pain Physicians; 🇺🇸 Elkton, Maryland, United States

Pain Care LLC; 🇺🇸 Stockbridge, Georgia, United States

Interventional Pain Care; 🇺🇸 Muncie, Indiana, United States

Comprehensive Pain & Rehabilitation; 🇺🇸 Pascagoula, Mississippi, United States

Michigan Pain Specialists; 🇺🇸 Brighton, Michigan, United States

Neurological Surgery, P.C.; 🇺🇸 Lake Success, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Carolina Pain Institute; 🇺🇸 Winston-Salem, North Carolina, United States

Integrated Pain Solutions; 🇺🇸 Columbus, Ohio, United States

Pain and Spine Center; 🇺🇸 Dayton, Ohio, United States

Performance Spine and Sports Physicians, P.C.; 🇺🇸 Pottstown, Pennsylvania, United States

Vertex Spine and Pain; 🇺🇸 Franklin, Tennessee, United States

Granger Pain and Spine; 🇺🇸 West Jordan, Utah, United States

The Center for Pain Relief; 🇺🇸 Charleston, West Virginia, United States

Coastal Pain & Spinal Diagnostics Medical Group; 🇺🇸 Carlsbad, California, United States

Holy Cross Orthopedics; 🇺🇸 Fort Lauderdale, Florida, United States

H. Lee Moffitt Cancer and Research Institute; 🇺🇸 Tampa, Florida, United States

The Pain Center of Arizona; 🇺🇸 Phoenix, Arizona, United States

Bright Health Physicians of PIH; 🇺🇸 Whittier, California, United States

Arizona Pain Specialists; 🇺🇸 Scottsdale, Arizona, United States

Comprehensive Pain Specialists; 🇺🇸 Broomfield, Colorado, United States

Pasadena Rehabilitation Institute; 🇺🇸 Pasadena, California, United States

The Mocek Spine Clinic; 🇺🇸 Little Rock, Arkansas, United States

Pacific Pain Medicine Consultants; 🇺🇸 Oceanside, California, United States

Bluegrass Pain; 🇺🇸 Louisville, Kentucky, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States