SPRINT PNS System for Lower Back Pain

Overseen By Ameet Primary PI, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnancy, Acute injury, Neoplastic diseases, others

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

Compensation: Varies

Number of Visits: 5

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the SPRINT PNS System for individuals with chronic lower back pain due to posterior sacroiliac joint complex pain. The researchers aim to determine if this system, which uses a small device to send electrical signals to nerves, can safely and effectively reduce pain over time. Individuals who have experienced severe lower back pain despite trying physical therapy and pain medications might be suitable candidates. Researchers will assess participants at various intervals to monitor improvements in pain and daily activities. As an unphased trial, this study provides a unique opportunity for patients to explore innovative pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must have received conservative treatment, including pain medication, for at least three months, it seems likely that you can continue your current medications.

What prior data suggests that the SPRINT PNS System is safe for treating chronic lower back pain?

Studies have shown that the SPRINT PNS (Peripheral Nerve Stimulation) System is safe for treating chronic pain. The FDA has approved it to help reduce chronic pain, and it can be used for up to 60 days. This system has relieved chronic pain without any serious side effects reported in the studies. However, the SPRINT PNS System is not safe to use during MRI scans.

In past research, many people who used the SPRINT PNS System reported long-term pain relief. In a follow-up with patients four years later, 70% avoided more invasive and expensive treatments. This suggests that the SPRINT PNS System is well-tolerated and could be a good option for those seeking pain relief without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SPRINT PNS System is unique because it uses peripheral nerve stimulation (PNS) to target chronic lower back pain directly. Unlike many standard treatments like medication or surgery, which can have significant side effects or require long recovery times, the SPRINT System is minimally invasive and aims to provide pain relief by modulating nerve activity. Researchers are excited about this treatment because it offers the potential for improved pain management and functional status without the drawbacks of more invasive procedures. Additionally, this approach could mean faster relief and better quality of life for patients suffering from chronic lower back pain.

What evidence suggests that the SPRINT PNS System is effective for chronic lower back pain?

Research has shown that the SPRINT PNS System, which participants in this trial will receive, can help treat long-term lower back pain. In one study, 70% of patients using SPRINT PNS avoided more invasive treatments for four years. Another study found that 73% of patients experienced significant pain relief, improving how pain affected their daily lives. The system stimulates nerves to reduce pain signals to the brain, offering long-lasting relief even after short-term use. Early results suggest it is a promising option for those with pain in the back of the pelvis area. ^{2 3 6 7 8}

Who Is on the Research Team?

Ameet Nagpal

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with chronic lower back pain, specifically from the posterior sacroiliac joint complex. Participants must be able to attend multiple follow-ups and complete questionnaires about their pain and disability levels.

Inclusion Criteria

Subject is scheduled for a commercial SPRINT case that has been authorized through their healthcare insurance

Subject is able to understand and consent to the study and device management and participating in follow-up surveys

My back pain severely limits my daily activities.

Exclusion Criteria

Pregnancy

I have not had spinal surgery in the last three months.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 months

1 visit (in-person)

Procedure

Placement of the SPRINT PNS system for treatment of chronic PSIJC pain

1 day

1 visit (in-person)

Post-procedure Follow-up

Participants are monitored for safety and effectiveness after the procedure

12 days

1 visit (in-person)

3-Month Follow-up

Assessment of pain intensity and functional status using NRS and ODI

3 months

1 visit (in-person)

3-Month Post Lead Removal Follow-up

Further assessment of pain intensity and functional status after lead removal

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SPRINT® System

Trial Overview

The SPRINT PNS System, a minimally invasive device designed for temporary use to relieve chronic lower back pain by electrically stimulating spinal nerves, is being tested for safety and effectiveness over several months.

How Is the Trial Designed?

Group I: SPRINT PNS System for chronic lower back pain Experimental Treatment 1 Intervention

This study will observe changes in pain intensity and functional status using the Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) over a 3-month follow-up period.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

SPR Therapeutics, Inc.

Industry Sponsor

Trials

14

Recruited

850+

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 pain ...

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 ...

The aim of this study is to understand whether the FDA-cleared SPRINT PNS system is safe and effective for the treatment of chronic PSIJC pain.

4.

sprpainrelief.com

sprpainrelief.com/press-releases/reset-clinical-trial-demonstrates-superior-pain-relief-with%20sprint-pns

RESET™ clinical trial demonstrates superior pain relief ... - SPR

The study successfully met its primary endpoint, with a greater proportion of patients treated with SPRINT PNS achieving ≥50 percent pain relief ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ...

Clinically meaningful improvements in pain interference were reported by 73% (n ​= ​53/73) of participants and among responders the average reduction in pain ...

6.

sprpainrelief.com

sprpainrelief.com/hcp/sprint-pns-system/safety-information

Safety Information - SPR

The SPRINT PNS System is MR Unsafe. – All MRI procedures, no matter the anatomic site, are contraindicated for patients with SPRINT PNS System.

7.

sprpainrelief.com

sprpainrelief.com/

SPR: Solutions for pain

The SPRINT PNS System is indicated for up to 60 days for: (i) Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; (ii) ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11234914/

A review of prospective studies regarding percutaneous ...

Percutaneous peripheral nerve stimulation is a US FDA-cleared treatment that can be implanted for up to 60 days. Data from prospective clinical studies have ...