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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Lisa Research Assistant/Coordinator
mockl@musc.edu
8438762211
Backup
Ameet Primary PI, MD
nagpal@musc.edu
Time Frame
Start Date: 2025-10-26
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 10
Treatments
Experimental: SPRINT PNS System for chronic lower back pain
This study will observe changes in pain intensity and functional status using the Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) over a 3-month follow-up period.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: SPR Therapeutics, Inc.

This content was sourced from clinicaltrials.gov