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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2021-05-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Back Pain Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peripheral Nerve Stimulation

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.

Group Type EXPERIMENTAL

SPRINT Peripheral Nerve Stimulation (PNS) System

Intervention Type DEVICE

The SPRINT PNS System is a device which 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). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain.

Interventions

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SPRINT Peripheral Nerve Stimulation (PNS) System

The SPRINT PNS System is a device which 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). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain.

Intervention Type DEVICE

Other Intervention Names

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SPRINT System Smartpatch System SPRINT Smartpatch

Eligibility Criteria

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Inclusion Criteria

* At least 21 years of age
* Chronic low back pain

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No