Peripheral Nerve Stimulation With the SPRINT® System in Chronic Posterior Sacroiliac Joint Complex Pain
Medical University of South Carolina
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.
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 complex (PSIJC) pain affects a large percentage of these patients, with a prevalence of 15-30% of all CLBP cases. The etiology of sacroiliac dysfunction is complex and often includes multiple factors. Patients may experience pain from inflammation of the SI joint itself, or dysfunction of the supporting tendons and ligaments may produce pain by affecting the ability of the joint to effectively tra…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 trauma…
Interventions
- DeviceSPRINT PNS System
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.
Locations (2)
- Medical University of South CarolinaCharleston, South Carolina
- Medical University of South CarolinaCharleston, South Carolina