Peripheral Nerve Stimulation for Back Pain

Not currently recruiting at 20 trial locations

Overseen By Mitchell Engle, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SPR Therapeutics, Inc.

Disqualifiers: Bmi > 40, Prior lumbar surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System in alleviating back pain compared to usual treatments. The device delivers small electrical pulses to nerves in the lower back to relieve pain. Participants will be divided into two groups: one using the PNS device and the other receiving standard care. The trial seeks individuals with chronic low back pain who have not undergone back surgery and do not have certain medical devices implanted. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially find relief from chronic 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.

What prior data suggests that the SPRINT Peripheral Nerve Stimulation System is safe for back pain?

Research shows that the SPRINT Peripheral Nerve Stimulation (PNS) System is generally well-tolerated. The FDA has approved this device for short-term use, up to 60 days, to help relieve chronic or acute pain, such as back pain. In a large study with over 6,100 patients, more than 71% experienced significant pain relief or improved quality of life, indicating the treatment's effectiveness and safety for many users. Additionally, a long-term follow-up study found that many patients continued to benefit from the treatment years later. No major safety concerns have been reported, reassuring about the treatment's safety for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPRINT Peripheral Nerve Stimulation (PNS) System because it offers a novel approach to managing back pain through electrical stimulation. Unlike standard treatments such as pain medications, physical therapy, or surgery, SPRINT PNS involves placing small leads in the lower back to directly stimulate nerves, potentially offering pain relief without systemic side effects. This method targets the source of pain more precisely and may provide benefits in just eight weeks, offering a non-invasive alternative that could reduce reliance on medications or more invasive procedures.

What evidence suggests that the SPRINT Peripheral Nerve Stimulation System is effective for back pain?

Studies have shown that the SPRINT Peripheral Nerve Stimulation (PNS) System, which participants in this trial may receive, effectively reduces chronic back pain. Research indicates that after using the SPRINT PNS System for 60 days, many patients experienced significant improvements in pain levels and daily activities. Long-term follow-up data reveals that 70% of patients avoided more invasive procedures years later. These findings suggest that the SPRINT PNS System provides lasting pain relief for those struggling with back pain. ^{1 2 4 5 6}

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.

Exclusion Criteria

You have a very high body mass index (BMI).

I have had surgery on my lower back before.

You have a pacemaker or other implanted electronic device.

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?

Group I: Group 1: Peripheral Nerve Stimulation (PNS) Active Control 1 Intervention

Subjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Group II: Group 2: Standard Interventional Management (Standard of Care) Active Control 1 Intervention

Subjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).

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:

• Symptomatic relief of chronic, intractable pain
• Post-surgical and post-traumatic acute pain
• Symptomatic relief of post-traumatic pain
• Symptomatic relief of post-operative pain

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 of 41 patients with chronic low back pain, those who responded positively to Transcutaneous Electrical Nerve Stimulation (TENS) were highly likely (94%) to also benefit from subsequent Peripheral Nerve Field Stimulation (PNFS) treatment, indicating TENS can help predict PNFS success.

Patients who had a positive response to TENS not only showed significant improvement in pain reduction during the PNFS trial but also experienced better overall outcomes in quality of life measures (SF12v2) and disability (ODI) at three and six months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Predictive Value of Transcutaneous Electrical Nerve Stimulation for Patient Selection in Peripheral Nerve Field Stimulation for Chronic Low Back Pain: A Prospective Study. Schwarm, FP., Ott, M., Nagl, J., et al.[2022]

A systematic review of 14 randomized controlled trials (RCTs) found moderate to strong evidence supporting the effectiveness of peripheral nerve stimulation (PNS) for treating various types of pain, including headaches, back pain, and pelvic pain.

The study highlights the need for more prospective trials to better identify which patient populations and specific pain conditions would benefit most from PNS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. Deer, TR., Esposito, MF., McRoberts, WP., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

Citations

1. sprpainrelief.com sprpainrelief.com/press-releases/four-year-follow-data-sprint-pns-low-back-pain-highlights-sustained-pain-relief

Four-year follow-up data on SPRINT® PNS for low back ... An average of four or more years after SPRINT PNS, 70 percent (16/23) of respondents were able to avoid progression to more costly, invasive, or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085521/

Four-Year Follow-Up from a Prospective, Multicenter Study of ... The present work explores the long-term clinical outcomes of Percutaneous 60-day PNS for chronic LBP approximately 4 years after initial treatment.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07166952

Peripheral Nerve Stimulation With the SPRINT® System in ... Previous studies have shown that peripheral nerve stimulation (PNS) can successfully treat multiple types of chronic pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ... Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain ...

5. relievepaincenter.com relievepaincenter.com/real-world-data-from-over-6100-patients-corroborates-significant-pain-reduction-from-prior-prospective-studies-for-patients-treated-with-sprint-pns/

Real-World Data from Over 6100 Patients Corroborates ... The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic ...

6. sprpainrelief.com sprpainrelief.com/hcp/sprint-pns-system/clinical-evidence

SPRINT PNS Clinical Evidence The largest retrospective review of real-word PNS data of over 6,100 patients, with over 71% demonstrating significant pain relief and/or improvement in quality ...