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

Peripheral Nerve Stimulation With the SPRINT® System in Chronic Posterior Sacroiliac Joint Complex Pain

This study will try a temporary SPRINT peripheral nerve stimulator to see if it reduces chronic PSIJC-related lower back pain in adults who have already tried physical therapy and medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of South Carolina (other)
• Locations: 2 sites (Charleston, South Carolina and 1 other locations)
• Trial ID: NCT07166952 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (over 18) with chronic PSIJC-related low back pain who are severely debilitated (ODI >40%), have tried at least three months of conservative care, and are scheduled for a commercial SPRINT procedure authorized by their insurer.

Not a fit: Patients with acute SIJ trauma, active spinal neoplasm or inflammation, recent SIJ steroid injection (within 1 month) or sacral lateral branch RFA (within 6 months), pregnancy, or other contraindications to neuromodulation are unlikely to be appropriate or to benefit from this intervention.

Why it matters

Potential benefit: If successful, the SPRINT PNS approach could reduce pain and disability from PSIJC and offer a less invasive option that may decrease reliance on injections or more invasive procedures.

How similar studies have performed: Prior studies of permanent neurostimulation have shown reduced pain and disability, and early reports of temporary SPRINT PNS suggest durable relief for some patients, though large randomized data remain limited.

Eligibility criteria

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 this trial is running

Charleston, South Carolina and 1 other locations

• 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

Conditions: Lower Back Pain