Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:21 - Any
Updated:1/31/2019
Start Date:June 23, 2017
End Date:April 2020

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A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

The purpose of this study is to evaluate the effectiveness of electrical stimulation (low
levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve
Stimulation (PNS) system. The System delivers mild electrical stimulation to the muscles in
the low back. The System includes up to four small wires (called "Leads") that are placed
through the skin into the muscles in the low back. The wires attach to device(s) worn on the
body that deliver stimulation (called Stimulators).


Key Inclusion Criteria:

- At least 21 years of age

- Chronic low back pain

Key Exclusion Criteria:

- Infection on or around the low back

- Conditions with increased risk of infection (e.g., valvular heart disease, compromised
immune system, history of recurrent skin infections)

- Implanted electronic device

- Body Mass Index (BMI) > 40

- Pregnant
We found this trial at
9
sites
Shrewsbury, New Jersey 07702
Principal Investigator: Sean Li, MD
Phone: 732-930-2423
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Charleston, West Virginia 25301
Principal Investigator: Timothy Deer, MD
Phone: 304-347-6144
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Charleston, WV
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Thomas Hopkins, MD
Phone: 919-681-4937
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Peoria, Arizona 85381
Principal Investigator: Abram Burgher, MD
Phone: 602-288-4673
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Peoria, AZ
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Richmond, Virginia 23235
Principal Investigator: Michael DePalma, MD
Phone: 804-330-2611
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Richmond, VA
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Tyler, Texas 75701
Principal Investigator: Ryan McKenna, MD
Phone: 903-531-0566
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Tyler, TX
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Walnut Creek, California 94598
Principal Investigator: Kasra Amirdelfan, MD
Phone: 925-478-5490
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Walnut Creek, CA
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Washington, District of Columbia 20037
Principal Investigator: Mehul Desai, MD, MPH
Phone: 202-808-8295
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Washington,
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Winston-Salem, North Carolina 27103
Principal Investigator: Leonardo Kapural, MD, PhD
Phone: 336-765-6181
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Winston-Salem, NC
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