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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07166952
Status
Recruiting
Apply to this trial

Conditions

  • Lower Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 26, 2025
Status verified
Nov 2025
Primary completion
Oct 26, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Numeric Rating Scale at 60 days and 90 days post procedure (lead removal) [ Time Frame: at 60 days (plus or minus 5 days) and 90 days (plus or minus 10 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Lisa E Mock
[email protected]
843-876-2211
Medical University of South CarolinaCharlestonSouth Carolina29425
Ameet Nagpal, MD
[email protected]
8438762211
Jenna Williams
[email protected]

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By research site
Medical University of South Carolina· Charleston, SC

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