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

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

sites

The Center for Clinical Research

Winston-Salem, North Carolina 27103

Principal Investigator: Leonardo Kapural, MD, PhD

Phone: 336-765-6181

from

Winston-Salem, NC