SPRINT PNS System for Lower Back Pain
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.12345Why 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.23678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Placement of the SPRINT PNS system for treatment of chronic PSIJC pain
Post-procedure Follow-up
Participants are monitored for safety and effectiveness after the procedure
3-Month Follow-up
Assessment of pain intensity and functional status using NRS and ODI
3-Month Post Lead Removal Follow-up
Further assessment of pain intensity and functional status after lead removal
What Are the Treatments Tested in This Trial?
Interventions
- SPRINT® System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
SPR Therapeutics, Inc.
Industry Sponsor