Abstract
PURPOSE: We aimed to evaluate the short-term efficacy and safety of early MSAT intervention in patients with acute radiating leg pain following traffic accidents. PATIENTS AND METHODS: This single-center, pragmatic, randomized controlled trial was conducted at a Korean medicine hospital and included 40 patients with radiating leg pain following traffic accidents hospitalized between November 2023 and October 2024. The patients received integrative Korean medicine treatment (IKMT, control) or IKMT combined with MSAT on hospitalization Days 2, 3, and 4. Primary and secondary outcomes, including the numeric rating scale(NRS) for radiating leg pain and low back pain, Oswestry disability index(ODI), and EuroQol-5-Dimension-5-Level(Q-5D-5L), were assessed daily form Day2 to Day5 during hospitalization and at a 14-day follow-up. Analyses included intention-to-treat and Cox regression for time-to-event outcomes. RESULTS: The MSAT group experienced a significantly greater reduction in radiating leg pain than the IKMT group on hospitalization Day5 (difference: 2.28, 95% confidence interval [CI]: 1.54-3.01; p < 0.001). Significant between-group differences were observed for the NRS scores of low-back pain (difference: 1.81; p < 0.001), ODI (difference: 11.23; p = 0.002), EQ-5D-5L (difference: -0.09; p = 0.006), etc. Kaplan-Meier analysis revealed a faster recovery (≥50% pain reduction) in the MSAT (median, 3.5 vs. 13 days; log-rank p < 0.001) than IKMT group with a 4.473 hazard ratio (95% CI: 1.658-12.067; p = 0.005). One mild adverse event occurred, which was unrelated to the intervention. CONCLUSION: This pilot study suggests that early MSAT combined with IKMT may provide more rapid pain relief, improved functional outcomes, and higher patient satisfaction compared with IKMT alone during the acute phase. REGISTRATION: ClinicalTrials.gov (NCT06179901).