Abstract
BACKGROUND: Requirements for the development of pre-surgical therapies for spinal pain disorders have arisen, with ultrasound-guided needle-knife therapy (US-NKT) gaining popularity as a minimally invasive treatment. This study aimed to evaluate the clinical outcomes of US-NKT, focusing on its effectiveness and safety. METHODS: A comprehensive literature survey was conducted by using 12 databases to identify randomized controlled trials (RCTs) comparing the effects of US-NKT with control in patients with spinal pain disorders. Characteristics of RCTs were extracted. Also, a meta-analysis of pain and physical function (PF) outcomes was performed at 1-week, 1-month, and 3-month follow-ups. Adverse events (AEs) were also analyzed. RESULTS: Of the 1,694 articles screened, 23 RCTs (n = 2,107) met the inclusion criteria, with 60.9% addressing spinal degenerative arthropathy. US-NKT significantly reduced pain at 1 week (standardized mean difference [SMD]: -1.11; 95% confidence interval [CI]: -1.42 to -0.79; I(2) = 73%) and 1 month (SMD: -1.74; 95% CI: -2.50 to -0.98; I(2) = 95%). However, the effects were not statistically significant at 3 months. PF improved significantly at all time .points, with the strongest effect at 1 week (SMD: -0.92; 95% CI: -1.42 to -0.42; I(2) = 71%). US-NKT demonstrated superior benefits for pain and PF compared with recommended therapies (at all-time points) or conventional NKT (at 1 week and 1 month). AEs were reported in 43.5% of RCTs, with fewer incidents in the US-NKT groups (4.6%) compared with the controls (13.8%). CONCLUSION: US-NKT demonstrates superior efficacy in reducing pain and improving PF compared with recommended therapies or conventional NKT, with a favorable safety profile. However, sustained benefits beyond 3 months remain inconclusive. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD42024529315.