BACKGROUND: Traffic injuries include acute low back pain (LBP) needing active treatment to prevent chronicity. This two-armed, parallel, assessor-blinded, randomized controlled trial evaluated the effectiveness and safety of progressive loading-motion style acupuncture treatment (PL-MSAT) for acute LBP following traffic accidents. METHODS: Based on an effect size of 1.03, 104 participants were recruited and divided in a 1:1 ratio into PL-MAST and control groups using block randomization. Both groups underwent integrative Korean medicine treatment (IKMT) daily; only the PL-MSAT group underwent three PL-MSAT sessions. The outcomes were assessed before and after the treatment sessions and at 1 and 3 months post-discharge. The primary outcome was the difference in the numeric rating scale (NRS) for LBP. The secondary outcomes included a visual analog scale for LBP, leg pain status, the Oswestry disability index, lumbar active range of motion (ROM), quality of life, Patient Global Impression of Change, and Post-Traumatic Stress Disorder Checklist adverse events. RESULTS: In the modified intention-to-treat analysis, 50 and 51 participants were included in the PL-MSAT and control groups. On Day 4, the mean LBP NRS score was 3.67 (3.44-3.90) in the PL-MSAT group, indicating a significantly lower NRS 0.77 (0.44-1.11) compared to 4.44 (4.20-4.68) for the control group (p < 0.001). The PL-MSAT group exhibited greater ROM flexion (-5.31; -8.15 to -2.48) and extension (-2.09; -3.39 to -0.80). No significant differences were found for the secondary outcomes and follow-ups. CONCLUSIONS: Compared with IKMT alone, PL-MSAT plus IKMT showed significantly better outcomes for reducing pain and increasing the ROM in acute LBP.
This is a pragmatic, two-armed, parallel, single-center, randomized controlled clinical trial for comparative evaluation between the effectiveness of integrated Korean medicine (IKM) and herbal medicine treatment with that of IKM monotherapy (control) for post-accident syndrome persistent after the acute phase. Participants were randomized into Herbal Medicine (HM, n = 20) and Control groups (n = 20) to receive the allocated treatment of 1-3 sessions/week for 4 weeks. Intention-to-treat analysis was conducted. The Difference of Numeric Rating Scale (NRS) change of overall post-accident syndromes from baseline to week 5 for the two groups was 1.78 (95% CI: 1.08-2.48; p < 0.001). Regarding secondary outcomes, a significant decrease compared to the baseline values was confirmed for NRS of musculoskeletal, neurological, psychiatric complaints and general symptoms of post-accident syndromes. In a survival analysis based on the recovery criteria of "patients with a reduction in the NRS of overall post-accident syndromes of ≥50%," the HM group showed a shorter time to recovery than the control group during the 17-week study period (p < 0.001 by the log-rank test). IKM combined with herbal medicine treatment significantly improved the quality of life by relieving somatic pain and alleviating the overall post-accident syndrome persistent after the acute phase; this effect was maintained for at least 17 weeks.
