The purpose of this phase III study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis, which is not currently approved by the FDA. This study will last approximately 26 weeks, which includes a screening period that includes 1 or 2 visits. Eligible subjects will undergo a 1:1 randomization with the SL 1002 formula or normal saline used as a placebo. After the screening visits and the study drug treatment visit (Day 1), the subject will be required to return to the study site for 5 additional study visits at approximately 1,2,3,4, and 6 months after the study drug treatment (Day 1). These visits will include physical examinations, knee assessments, patient questionnaires, and the collection of vital signs, and blood and urine samples. This study also requires daily electronic data entries from Day 1 to the end of the study.
The purpose of this research study is to evaluate patient outcomes following treatment with the SPRINTĀ® Peripheral Nerve Stimulation (PNS) System for chronic posterior sacroiliac joint complex (PSIJC) pain. The PNS system is a temporary nerve stimulator, which provides non-surgical treatment that reduces pain by sending electrical pulses to the nerves that carry signals to/from your spinal cord. SPRINT PNS system is currently FDA approved to treat pain after surgery, pain after trauma, and pain that is difficult to treat. The study will consist of 3 total visits for each participant, over the course of roughly 6 months.