Peripheral Nerve Stimulation for Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the SPRINT Peripheral Nerve Stimulation System treatment different from other treatments for back pain?
The SPRINT Peripheral Nerve Stimulation System is unique because it uses electrical stimulation of peripheral nerves to block pain signals, offering a less invasive and potentially safer alternative to traditional treatments like radiofrequency ablation or permanently implanted devices. It can provide long-term pain relief with a short-term implant, reducing the need for opioid painkillers.12345
What data supports the effectiveness of the treatment SPRINT Peripheral Nerve Stimulation System for back pain?
Research shows that peripheral nerve stimulation (PNS) can help relieve chronic low back pain and reduce the need for opioid painkillers. PNS works by using electrical signals to block pain messages from reaching the brain, and it has been used successfully for various types of pain, including back pain.14567
Are You a Good Fit for This Trial?
This trial is for individuals with chronic low back pain. Participants should not have a BMI over 40, any previous lumbar surgery, implanted electronic devices, or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive electrical stimulation using the SPRINT Peripheral Nerve Stimulation (PNS) System for back pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
Crossover
Participants in the standard care group may crossover to receive PNS after 12 months
What Are the Treatments Tested in This Trial?
Interventions
- SPRINT Peripheral Nerve Stimulation (PNS) System
SPRINT Peripheral Nerve Stimulation (PNS) System is already approved in United States for the following indications:
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Who Is Running the Clinical Trial?
SPR Therapeutics, Inc.
Lead Sponsor
United States Department of Defense
Collaborator