Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain

NCT07166952 | Recruiting FDA Device

• 1 other identifier: Pro00140724
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale at 60 days and 90 days post procedure (lead removal)

  at 60 days (plus or minus 5 days) and 90 days (plus or minus 10 days)

Secondary Outcomes (1)

• Measurement of the Oswestry Disability Index (ODI) at the 60 and 90 day post Lead removal

  at 60 days (plus or minus 5 days) and 90 days (plus or minus 10 days) post Lead removal

Study Arms (1)

SPRINT PNS System for chronic lower back pain

EXPERIMENTAL

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.

Device: SPRINT PNS System

Interventions

SPRINT PNS System DEVICE

This study will evaluate patient-reported outcomes, including pain and function, following standard clinical use of the SPRINT PNS System for posterior sacroiliac joint complex (PSIJC) pain.

SPRINT PNS System for chronic lower back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• SPR Therapeutics, Inc.: collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ameet Nagpal

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Research Assistant/Coordinator

CONTACT

8438762211; mockl@musc.edu

Ameet Primary PI, MD

CONTACT

nagpal@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 11, 2025
• Study Start: October 26, 2025
• Primary Completion (Estimated): October 26, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)