Actively Recruiting
Peripheral Nerve Stimulation With the SPRINT ae System in Chronic Posterior Sacroiliac Joint Complex Pain
Led by Medical University of South Carolina · Updated on 2025-11-14
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
S
SPR Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic lower back pain is a common cause of disability among older adults, with a significant portion caused by pain in the posterior sacroiliac joint complex (PSIJC). This research aims to evaluate the safety and effectiveness of the FDA-cleared SPRINT Peripheral Nerve Stimulation (PNS) system as a treatment for chronic PSIJC pain. The study addresses the need for alternative therapies due to recent limitations on existing treatments like radiofrequency ablation and joint fusion. Participants will receive the SPRINT PNS system, a minimally invasive device that temporarily stimulates targeted spinal nerves to reduce pain. The study includes five time points: screening, the procedure within three months, follow-ups at 12 days and 3 months post-procedure, and a final follow-up 3 months after lead removal. Researchers will observe changes in pain and function over a 3-month period following device use. During the study, participants will undergo physical exams and complete pain and disability questionnaires at specified follow-ups. The primary outcome measured will be pain intensity using the Numeric Rating Scale at 60 and 90 days after the procedure. The Oswestry Disability Index will also be assessed at these times to evaluate functional improvement. The entire participation process spans several months, including device removal and ongoing monitoring.
CONDITIONS
Brief Title
Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sacroiliac pain as diagnosed above
- Age 18 years or older
- Severe sacroiliac joint pain causing significant disability with initial Oswestry Disability Index score greater than 40%
- Received conservative treatment including physiotherapy and pain medication for at least three months
- Able to understand and consent to the study and participate in follow-up surveys
- Scheduled for a commercial SPRINT procedure authorized through healthcare insurance
You will not qualify if you...
- Pregnancy
- Under 18 years of age
- Acute traumatic injury of the sacroiliac joint
- Active inflammation or cancer affecting the sacroiliac joint
- Spinal surgery within the last three months
- Sacroiliac joint steroid injection within the past month or sacral lateral branch radiofrequency ablation within the past six months
- Contraindications for neuromodulation device including severe psychiatric disease, severe bleeding disorder, acute infection, or active autoimmune disease with immunosuppression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive the temporary SPRINT Peripheral Nerve Stimulation (PNS) System targeting the sacral lateral branch to treat posterior sacroiliac joint complex pain.
1 procedure visit and lead removal visit
Duration - Approximately 3 months
Participants are followed for up to 3 months after lead removal to assess pain and functional status using surveys.
Visits at about 60 days and 90 days post lead removal
Trial Site Locations
Total: 2 locations
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
L
Lisa Research Assistant/Coordinator
A
Ameet Primary PI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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