SPRINT peripheral nerve stimulation for chronic posterior sacroiliac joint (PSIJC) low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with chronic posterior sacroiliac joint complex (PSIJC) pain who remain debilitated despite at least three months of conservative treatment. Participants scheduled for a commercial SPRINT PNS case will receive a minimally invasive percutaneous lead placed under the skin to electrically stimulate sacral lateral branch nerves. Outcomes will track pain, disability (Oswestry Disability Index >40% at baseline), and safety over follow-up to determine whether temporary SPRINT PNS provides sustained symptom relief. Enrollment excludes recent SIJ injections or recent radiofrequency ablation, active spinal neoplasm, recent spinal surgery, pregnancy, or other contraindications to neuromodulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Ameet Nagpal — Medical University of South Carolina
• Study coordinator: Lisa Research Assistant/Coordinator
• Email: mockl@musc.edu
• Phone: 8438762211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.