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SPRINT® System for Chronic Sacroiliac Joint Pain

This study is looking at how well the SPRINT® Peripheral Nerve Stimulation (PNS) System works for people with chronic pain in their posterior sacroiliac joint complex (PSIJC), a common cause of lower back pain. The SPRINT® System involves placing a small wire under the skin to stimulate nerves that send pain signals. Researchers want to see if this treatment can improve your pain and how well you can do daily activities. You might be able to join if you are over 18, have severe PSIJC pain, and have tried other treatments like physical therapy and pain medication for at least three months. The study will measure your pain levels at 60 and 90 days after the wire is removed. The study plans to enroll 10 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive the SPRINT® PNS System. It plans to enroll 10 participants.
What's involved
You would receive the SPRINT® PNS System and participate in follow-up appointments to assess pain and function at 60 and 90 days after the lead is removed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 90 days after the lead removal procedure.

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NCT07166952

Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain

Recruiting
NAAges 18+Interventional
Medical University of South Carolina
~10 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:SPRINT PNS System

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numeric Rating Scale at 60 days and 90 days post procedure (lead removal)
Measured over at 60 days (plus or minus 5 days) and 90 days (plus or minus 10 days)

Conditions

Lower Back Pain

Explore related trials

Lower Back Pain

Where it's being run

2 sites across 1 states
South Carolina2

Study leadership

  • Ameet Nagpal · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Lisa Research Assistant/Coordinator
[email protected]
8438762211
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Sacroiliac pain as diagnosed above
Subject greater than 18 years old
Subject is severely debilitated by SIJ pain, with initial ODI score \> 40%
Subject received conservative treatment for at least three months including physiotherapy and pain medication
Subject is able to understand and consent to the study and device management and participating in follow-up surveys
Subject is scheduled for a commercial SPRINT case that has been authorized through their healthcare insurance

Exclusion

Pregnancy
Subject is under the age of 18 years
Acute traumatic injury of the sacral iliac joint
Active inflammation or neoplastic infiltration of the SIJ
Neoplastic diseases of the spine
Spinal surgery within the last three months
Sacroiliac joint steroid injection within the past 1 month or sacral lateral branch radiofrequency ablation within the past 6 months
Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosuppression)

What this trial measures

  • Numeric Rating Scale at 60 days and 90 days post procedure (lead removal)at 60 days (plus or minus 5 days) and 90 days (plus or minus 10 days)