230 Participants Needed

Peripheral Nerve Stimulation for Back Pain

Recruiting at 18 trial locations
LE
DT
ZM
KA
ME
Overseen ByMitchell Engle, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: SPR Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

I have long-term lower back pain.
I have long-term lower back pain.
I have long-term lower back pain.
See 1 more

Exclusion Criteria

You have a very high body mass index (BMI).
Pregnant
You have a pacemaker or other implanted electronic device.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electrical stimulation using the SPRINT Peripheral Nerve Stimulation (PNS) System for back pain

8 weeks
Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Periodic visits up to 24 months post-treatment

Crossover

Participants in the standard care group may crossover to receive PNS after 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • SPRINT Peripheral Nerve Stimulation (PNS) System
Trial Overview The study compares standard treatments for back pain to the SPRINT Peripheral Nerve Stimulation (PNS) System which delivers electrical stimulation to nerves in the lower back and is FDA-cleared for up to 60 days use.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Group 1: Peripheral Nerve Stimulation (PNS)Active Control1 Intervention
Group II: Group 2: Standard Interventional Management (Standard of Care)Active Control1 Intervention

SPRINT Peripheral Nerve Stimulation (PNS) System is already approved in United States for the following indications:

🇺🇸
Approved in United States as SPRINT PNS System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

SPR Therapeutics, Inc.

Lead Sponsor

Trials
14
Recruited
850+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Published Research Related to This Trial

In a study involving 9 subjects, percutaneous peripheral nerve stimulation (PNS) led to significant pain relief, with 67% of participants experiencing at least a 50% reduction in pain intensity after one month of treatment, and many maintaining this relief for up to 12 months post-treatment.
The study found no serious adverse events, suggesting that PNS is a safe and effective alternative for managing chronic low back pain, potentially reducing the need for opioids and invasive procedures.
Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short-Term Implant.Gilmore, CA., Kapural, L., McGee, MJ., et al.[2020]
Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.
PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.
Mechanism of Action of Temporary Peripheral Nerve Stimulation.Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]
A new training curriculum for Peripheral Nerve Stimulation (PNS) has been developed by a multidisciplinary task force to standardize education and improve proficiency in this effective treatment for chronic pain.
The curriculum includes defined milestones for learners at different levels (early, advanced, and practitioner) and covers essential skills such as professionalism, medical knowledge, and procedural skills, ensuring comprehensive training in PNS therapy.
Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society.Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

Citations

Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short-Term Implant. [2020]
Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]
Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]
Peripheral Nerve Stimulation in Pain Management: A Systematic Review. [2022]
A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. [2021]
Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]
The Predictive Value of Transcutaneous Electrical Nerve Stimulation for Patient Selection in Peripheral Nerve Field Stimulation for Chronic Low Back Pain: A Prospective Study. [2022]
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