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

SPR Therapeutics

Status: Completed

Conditions: Back Pain; Low Back Pain

Treatments: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03179202

0142-CSP-000

Details and patient eligibility

About

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).

Enrollment: 166 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

Peripheral Nerve Stimulation

Experimental group

Description:

All study subjects will have up to 4 Leads placed in their low back, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System