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

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 nerves 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