Peripheral Nerve Stimulation for Back Pain

Recruiting at 18 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

230 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

Eligibility Criteria

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).

Pregnant

You have a pacemaker or other implanted electronic device.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation in Pain Management: A Systematic Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2022]