Randomized Evaluation of Lumbar Injection Effectiveness and Function

The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained herniated lumbar disc. The study will enroll adults 18 to 75 years of age with a single-level contained lumbar disc herniation who continue to have symptoms despite at least 6 weeks of non-surgical treatment and a previous lumbar spine injection. The main questions it aims to answer are:

• Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone?
• Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits? Researchers will compare participants who receive Triojection® followed by SNRB with participants who receive SNRB alone to determine whether the investigational treatment provides improved clinical outcomes. Participants will:
• Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone.
• Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement.
• Undergo physical and neurological examinations during study follow-up visits.
• Have MRI scans performed at selected study visits to evaluate changes in the treated disc.
• Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment. Up to 300 participants will be enrolled at up to 30 investigational sites in the United States and Canada and followed for approximately 24 months after treatment.