NCT07166952 Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain
| NCT ID | NCT07166952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Lower Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-10-26 |
| Primary Completion | 2027-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-10-26 with a primary completion date of 2027-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (PSIJC) pain (source), making it a target for treatment. Peripheral Nerve Stimulation (PNS) is a procedure that involves the placement of a lead under the skin with local anesthetic and electrically stimulating designated spinal nerves that deliver pain signals to the brain. It has emerged as a promising alternative to drug, injection, and radioablative therapies. Its use has been supported by previous studies of subjects who received permanent neurostimulation and experienced benefits such as decreased sensation of pain and perceived level of disability. SPRINT is a minimally invasive PNS system of interest due to its ability to provide long-term pain relief after temporary administration of PNS. The aim of this study is to understand whether the FDA-cleared SPRINT PNS system is safe and effective for the treatment of chronic PSIJC pain. This prospective clinical study will assess 10 subjects that meet the inclusion and exclusion criteria across 5 separate time points- 1.) Screening; 2.) Procedure within 3 months of screening; 3.) 12-day post-procedure follow-up; 4.) 3-month post-procedure follow-up; 5.) 3-Month post lead removal follow-up. The subjects will be required to complete physical examinations, and VAS and ODI questionnaires at timepoints 3, 4, and 5.
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)
Contact & Investigator
Ameet Nagpal
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07166952 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07166952 currently recruiting?
Yes, NCT07166952 is actively recruiting participants. Contact the research team at mockl@musc.edu for enrollment information.
Where is the NCT07166952 trial being conducted?
This trial is being conducted at Charleston, United States, Charleston, United States.
Who is sponsoring the NCT07166952 clinical trial?
NCT07166952 is sponsored by Medical University of South Carolina. The principal investigator is Ameet Nagpal at Medical University of South Carolina. The trial plans to enroll 10 participants.