Caudal epidural steroid injections versus selective nerve root blocks for single-level lumbar spinal stenosis: a study protocol for a randomized controlled trial

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative condition associated with old age. Its incidence continues to increase with the rapidly aging population in China. Treatment for LSS usually begins with conservative treatments, as some patients refuse surgical procedures or have surgery contraindications. Caudal epidural steroid injections (CESIs) and selective nerve root blocks (SNRBs) are two commonly used conservative treatments for LSS, which have proven to be effective at relieving LSS symptoms in many studies. However, there are no randomized controlled trials comparing these two procedures. We planned the first study to assess which one of these two procedures is more effective in treating LSS. We will compare the efficacy of these two treatment methods in terms of duration of symptom relief and recurrence rate. We hope our findings will help clinicians choose an optimal treatment for LSS patients. METHODS/DESIGN: We plan to conduct a 1-year randomized controlled trial that will include a total of 76 subjects. They will be randomly divided into two groups: group A (patients will receive CESIs) and group B (patients will receive SNRBs). Two days before the procedure, we will assess these patients using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, Oswestry Disability Index (ODI), and numeric rating scale (NRS) for pain. One day, 2 weeks, 3 months, 6 months, and 1 year after the procedure, we will assess the condition of these patients again with the NRS and ODI. DISCUSSION: We hope our findings will lay the foundation for the design of further comprehensive studies and help clinicians make a choice between CESIs and SNRBs for LSS patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900028038. Registered on 8 December 2019