Status:
RECRUITING
Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
SPR Therapeutics, Inc.
Conditions:
Lower Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic lower back pain is a significant cause of disability, affecting 21-68% of people 60 years of age and older (source). Of these cases, 15-30% are attributed to posterior sacroiliac joint complex...
Detailed Description
Chronic low back pain (CLBP) is a leading cause of disability in the United States, with a recent review finding a prevalence between 21-68% of all people aged 60 or older. Posterior sacroiliac joint ...
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)
Key Trial Info
Start Date :
October 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07166952
Start Date
October 26 2025
End Date
October 31 2027
Last Update
November 14 2025
Active Locations (2)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425