Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients



Status:Suspended
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:22 - Any
Updated:4/21/2016
Start Date:April 2013
End Date:March 2016

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SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666

The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve
Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of
chronic, intractable post-surgical back pain in adults.

This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Key Inclusion Criteria:

- Have persistent back pain for at least 6 months

- Had back surgery at least 6 months ago

- Have tried pain medications and physical therapy

- Read and understand written English or Spanish

- Male or non-pregnant female. If female of child-bearing potential, and if sexually
active, must be using a medically-acceptable method of birth control during study
participation

- Willing and able to undergo surgical implant procedure, attend visits as scheduled,
and comply with the study requirements

- Have an expected lifespan greater than 12 months

Key Exclusion Criteria:

- Have leg pain in addition to back pain.

- Currently enrolled in or plan to enroll in another drug and/or device study

- Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or
fibromyalgia

- Have an active systemic infection or are immunocompromised

- Will be exposed to diathermy or anticipate needing a full-body MRI scan

- Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator

- Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal
drug delivery system or requires additional back surgery
We found this trial at
27
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Orlando, FL
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3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
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Austin, Texas
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Carlsbad, California 92009
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Cincinnati, Ohio 45219
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Cuyahoga Falls, Ohio
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Greenfield, WI
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Greensburg, Pennsylvania
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Huntington Beach, California
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Merritt Island, Florida 32953
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Mount Pleasant, South Carolina
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New York City, New York
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Pascagoula, Mississippi 39581
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona
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Phoenix, Arizona 85050
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Springfield, Missouri 65807
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Webster, Texas 77598
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